Skip to content
Recall Observatory FDA recall evidence

Device product

Cardiosave Hybrid and rescue IABP

Z-1248-2016

December 16, 2015

Class II

Product summary

Firm
Maquet Datascope Corp - Cardiac Assist Division
Event
Event 72890
Status
Terminated
Classification
Class II
Quantity
1243 units US; 1107 units OUS
Official record key
device-enforcement:Z-1248-2016

Official wording

Reason: Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

Code information: Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

Distribution pattern: Worldwide Distribution- Nationwide Distribution including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.