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Terminated

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

FDA Recall Z-1140-2015 · Posted 2015-02-23

Recalling FirmMaquet Datascope Corp - Cardiac Assist Division
Recall StatusTerminated
Product CodeDSP
Date Initiated2015-01-30
Date Terminated2017-09-29
Product Quantity1,300 units

Reason for Recall

Power supply malfunction complaints related to suboptimal thermal management.

Firm Action

Maquet Inc. sent a recall letter/return response form dated 1/30/2015.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112372CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC · 2011-09-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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