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Safety and Quality Concerns with Getinge Cardiovascular Devices - FDA Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices:

  • Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and

  • Getinge/Maquet Cardiohelp system and HLS Sets.

Please visit the FDA's official website to read the rest of this letter. 

Getinge’s Actions in Response to FDA's Letter to Health Care Providers Regarding Cardiosave, Cardiohelp and HLS Set Devices

On May 8th, the U.S. Food and Drug Administration (FDA) published a letter to health care providers on their website, alerting them about safety and quality concerns of Getinge’s Cardiosave Intra-Aortic Balloon Pump (IABP), Cardiohelp System and HLS Set Advanced. The safety and quality concerns are related to previously communicated recalls.

Please download the notice for more comprehensive information and instructions.

997581 Patient Leakage Current Too High

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device Removal for certain units of the CARDIOHELP-i System, due to a non-conformance related to the assessment of leakage current during the manufacture of the CARDIOHELP-i System and a nonconforming sensor panel that can result in leakage current that exceeds the allowable limit. 

Please download the notice for more comprehensive information and instructions.

946519 - Emergency Priming Line Unsealed

Maquet Cardiopulmonary GmbH (MCP)/Getinge is notifying customers of additional lots of the Emergency Priming Line, a component of the HLS Set, that are affected by a voluntary Medical Device Correction (originally initiated on January 16, 2024) due to a potentially compromised sterile barrier. These additional lots are provided in bold italicized text in the above list, along with the related manufacturing and distribution date ranges that have been updated accordingly.

Please download the notice for more comprehensive information and instructions.

946519 - Emergency Priming Line Unsealed.

Maquet Cardiopulmonary GmbH (MCP)/Getinge is notifying you about an issue related to a potentially compromised sterile barrier of the Emergency Priming Line, a component of the HLS Set.

Please download the notice for more comprehensive information and instructions.

782698 False EAN UPC UDI Bubble Sensor

Getinge / Maquet Cardiopulmonary GmbH is initiating a voluntary Medical Device Correction for the above referenced serial numbers of Bubble Sensor BS 3/8x3/32 L1.7 (Product Code / REF: 70105.5720) (the “Bubble Sensor”) due to an incorrect Unique Device Identifier (UDI) on the product label.

Please download the notice for more comprehensive information and instructions.

879551 IFU Contains Incorrect Factory Settings

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device Correction for the CARDIOHELP-i Heart Lung Support System to provide a new version of the Instructions for Use (IFU) to customers who received previous versions of the IFU that incorrectly described certain factory settings for the device (see Figure 1 through Figure 6 in the notice). The devices, however, are manufactured with the appropriate factory settings and functioning as intended.

Please download the notice for more comprehensive information and instructions.

881841 Leakage Current Measurement Against Standard

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device Correction for the CARDIOHELP-i Heart Lung Support System, due to a non-conformance related to the assessment of leakage current during the manufacture of the CARDIOHELP-i System. 

Please download the notice for more comprehensive information and instructions.

881842 Broken Venous Probe Cable

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device Removal for the CARDIOHELP-i Heart Lung Support System, due to the potential that the now-obsoleted design of the venous probe connection cable may break, which could lead to the inability to transmit data from the venous probe to the CARDIOHELP-i System. This field action does not affect you if you already use the venous probe connection cable that is made with polyurethane and is of longer length (320 +/- 10mm)

Please download the notice for more comprehensive information and instructions.

626803 Cardiohelp Slide Rail Holder

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device. Correction for the CARDIOHELP-i Heart Lung Support System, due to an insufficient fixation (weld) of the slide rail plate. 

Please download the notice for more comprehensive information and instructions.

874872 Emergency Drive

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device REMOVAL for the CARDIOHELP Emergency Drive, due to a possible blocking or impairment of the CARDIOHELP Emergency Drive. Getinge will be removing the affected emergency drives in order to repair the devices. There are loaner devices available so that you may continue to use your CARDIOHELP System while your device is being repaired.

Please download the notice for more comprehensive information and instructions.

745922 - Insufficient Evidence of Packaging Sterility - Updated Letter

Maquet Cardiopulmonary GmbH (MCP)/Getinge sent you an Urgent Medical Device Correction letter on February 13, 2023 notifying you of the initiation of a voluntary Medical Device. Correction for the HLS Set Advanced (disposable in the CARDIOHELP System) due to insufficient evidence of packaging sterility. This is an update to the initial notification.

Please download the notice for more comprehensive information and instructions.

781869 Potentially Compromised Sterile Barrier

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device. Correction for the HLS Set Advanced (disposable in the CARDIOHELP System) due to insufficient evidence of packaging sterility.

Please download the notice for more comprehensive information and instructions.

661861 Potentially Compromised Sterile Barrier

Maquet Cardiopulmonary GmbH (MCP)/Getinge is expanding its voluntary Medical Device Removal initiated on November 6, 2020 for the HLS Set Advanced (disposable for Cardiohelp). Maquet Cardiopulmonary GmbH (MCP) has continued to receive customer complaints (a total of 34 as of July 15, 2022) of damage to the sterile barrier the HLS Set Advanced. Additional part numbers and lots are being added to the scope of this voluntary Medical Device Removal. Two issues have been identified with distinct root causes and affect different products, but they both can potentially cause a breach in the sterile barrier that may result in compromised product sterility.

Please download the notice for more comprehensive information and instructions.

946519 - Unsealed Packaging - Updated Letter

Maquet Cardiopulmonary GmbH (MCP)/Getinge is notifying customers of additional lots of ROTAFLOW Centrifugal Pumps (RF-32 pumps) that are affected by a voluntary Medical Device Removal (originally initiated on January 8, 2024) due to a potentially compromised sterile barrier. As a result of these added lot numbers, the related manufacturing and distribution date ranges have been updated accordingly. Additionally, the UDI Device Identifiers reported previously had a typographical error. 

Please download the notice for more comprehensive information and instructions.

946519 - Unsealed Packaging

Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device Removal for certain lots of ROTAFLOW Centrifugal Pumps (RF-32 pumps) due to a potentially compromised sterile barrier.

Please download the notice for more comprehensive information and instructions.

828176 Potentially Compromised Sterile Barrier

Maquet Cardiopulmonary GmbH/Getinge is initiating a voluntary Medical Device Removal for the Cardiotomy Reservoirs (VKMO 10000-USA, VKMO 11000-USA), QUADROX-iD (BEQ-HMOD 30000, HMOD 70000, and BEQHMOD 70000), QUADROX-iR (HMO 71100, HMO 70100, BEQ-HMO 71100, HMO 51100, HMO 50100, BEQHMO 51100), and QUADROX-, i (HMO 50000, HMO 51000, HMO 70000, HMO 71000, and BEQ_HMO 71000, HMO 10000, HMO 11000, HMO 30000 and HMO 31000) Oxygenators due to a risk of potentially compromised packaging sterility that may result in the risk of infection/harm to the patient. All lots are being removed.

Please download the notice for more comprehensive information and instructions.

Safety and Quality Concerns with Getinge Cardiovascular Devices - FDA Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices:

  • Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and

  • Getinge/Maquet Cardiohelp system and HLS Sets.

Please visit the FDA's official website to read the rest of this letter. 

Getinge’s Actions in Response to FDA's Letter to Health Care Providers Regarding Cardiosave, Cardiohelp and HLS Set Devices

On May 8th, the U.S. Food and Drug Administration (FDA) published a letter to health care providers on their website, alerting them about safety and quality concerns of Getinge’s Cardiosave Intra-Aortic Balloon Pump (IABP), Cardiohelp System and HLS Set Advanced. The safety and quality concerns are related to previously communicated recalls.

Please download the notice for more comprehensive information and instructions.

848208 Autofill Alarms, Gas Loss Gas Gain, System Over Temp, Fiber Optic Damage

Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to the following four (4) identified system conditions: Issue 1: Autofill Alarms Issue 2: Gas Loss & Gas Gain Alarms Issue 3: System Over-Temperature Issue 4: Fiber Optic Damage

Please download the notice for more comprehensive information and instructions.

848201 11 Poor or No ECG Signal, Docking Power Battery Failure

Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to the following two (2) identified system conditions: Issue 1: Docking/Power Battery Failure Issue 2: Poor or No ECG Signal.

Please download the notice for more comprehensive information and instructions.

841554 Power Management Board

Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to two issues that could affect IABP performance.

Please download the notice for more comprehensive information and instructions.

763850 Unexpected Shutdown - Coiled Cable Code 111 + 112 and O-Ring Helium Leak

Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to four issues that could affect IABP performance.

Please download the notice for more comprehensive information and instructions.

783344 Safety Disks

This is a new recall, separate from the earlier reported recall involving four (4) issues regarding unexpected shutdown and helium leaks. Datascope Corp., a subsidiary of Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP), Safety Disks, and PIMs, due to the Safety Disk not meeting a performance requirement that may result in the reduction of Intra-Aortic Balloon catheter (IAB) displacement volume by up to 3.6%.

Please download the notice for more comprehensive information and instructions.

744060 Potential shutdown from blood entering the IABP console UPDATE

Datascope Corp., a subsidiary of Getinge, is initiating an update to the previously submitted voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra- Aortic Balloon Pump (IABP) due to increased risks to patients should blood within a perforated IAB catheter enter the IABP console. In addition to the risk of gas emboli from a perforated balloon catheter, an unexpected shutdown may occur. We are aware of other events of blood entering the device not leading to an unexpected shutdown, and we are continuing to investigate these events.

Please download the notice for more comprehensive information and instructions.

744060 Potential shutdown from blood entering the IABP console

Datascope Corp., a subsidiary of Getinge, is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to increased risks to patients should blood within a perforated IAB catheter enter the IABP console. 

Please download the notice for more comprehensive information and instructions.

577031 IPX1 Fluid Ingress

Datascope/Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to the possibility of fluid ingress. Fluid entering the Cardiosave IABP may short various electronic components thus leading to system shutdown.

Please download the notice for more comprehensive information and instructions.

529235 Helium Indicator + Shut Down Upon Battery Removal

Datascope/Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to two issues that could affect IABP performance.

Please download the notice for more comprehensive information and instructions.

527856 Li-Ion Battery Packs

Datascope/Getinge is initiating a voluntary Medical Device Removal for a limited number of Cardiosave Li-Ion Battery Packs with Part Number/REF Number 0146-00-0097 used with Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to the potential risk of unexpected short battery runtime.

Please download the notice for more comprehensive information and instructions.

475699 Ripple 20

Datascope/Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to cybersecurity vulnerabilities in a widely used low-level TCP/IP software library developed by Treck, Inc. that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).

Please download the notice for more comprehensive information and instructions.

475613 - Battery Usage, Charging, Maintenance and Storage Instructions

This is to notify you that the Datascope IABP devices(s) (Cardiosave Hybrid IABP, Cardiosave Rescue IABP, CS300 IABP and CS100 IABP) your facility may have received from Getinge are part of a field correction initiated May 16, 2019. This field correction is being conducted to ensure that all IABP users follow each device's Operating Instructions Manual for recommendations on usage, charging, maintenance and storage of the batteries, as battery run times and discharge cycles vary between IABP models. If battery maintenance is not performed per the Operating Instructions Manual for each IABP, the battery may provide less than the expected minimum run time of operating power per battery.

Please download the notice for more comprehensive information and instructions.

475427 Altitude Autofill Failure

Maquet/Getinge is initiating a voluntary Medical Device Correction for the Cardiosave Intra-Aortic Balloon Pump (IABP) due to the issue presented below. This issue could result in an interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft. This condition could potentially lead to patient hemodynamic instability.

Please download the notice for more comprehensive information and instructions.