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Recall Observatory FDA recall evidence

Device product

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Z-0099-2019

September 20, 2018

Class I

Product summary

Firm
Maquet Datascope Corp - Cardiac Assist Division
Event
Event 81055
Status
Ongoing
Classification
Class I
Quantity
N/A
Official record key
device-enforcement:Z-0099-2019

Official wording

Reason: There is a potential for 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.

Code information: UDI - 10607567108391 All Serial Numbers

Distribution pattern: US Nationwide; Internationally to 77 countries

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for 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.