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Dokument
Customer letter for four identified issues, July 31, 2023
Voluntary Medical Device Correction for the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) related to Autofill Alarms, Gas Loss & Gas Gain Alarms, System…
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Dokument
Addendum to: Cardiosave IABP Operating Instructions - Clinical Considerations IAB IFU Balloon Membrane Perforation MCA000000549 C_OUS
Addendum to: Cardiosave IABP Operating Instructions - Clinical Considerations IAB IFU Balloon Membrane Perforation MCA000000549 C_OUS
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Dokument
JAN2023 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…
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Dokument
MCA000000556 C_US_Addendum to: Cardiosave IABP Operating Instructions-Clinical Considerations IAB IFU Balloon Membrane Perforation
MCA000000556 C_US_ Addendum to: Cardiosave IABP Operating Instructions-Clinical Considerations IAB IFU Balloon Membrane Perforation
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Dokument
Signature_Banner_IABP_Product_Support_Page_MCA00003220 Rev A_OUS
Signature Banner IABP Product Support Page MCA00003220 Rev A for OUS use
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Dokument
MDSAP Certificate TUV SUD QS6 102541 0004 Rev. 03 IABP and Accessories
MDSAP Certificate TUV SUD QS6 102541 0004 Rev. 03 IABP and Accessories, HL40, Collagen ISO 13485:2016 Effective: 2023-02-06 Exp. 2026-02-05
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Dokument
UPDATED - Urgent Medical Device Product Correction
Cardiosave Intra-Aortic Balloon Pumps (IABP) performance issues – Version 2
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