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Terminated

Cardiosave Hybrid and rescue IABP

FDA Recall Z-1248-2016 · Posted None

Recalling FirmMaquet Datascope Corp - Cardiac Assist Division
Recall StatusTerminated
Product CodeDSP
Date Initiated2015-12-16
Date Terminated2018-06-01
Product Quantity1243 units US; 1107 units OUS

Reason for Recall

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.

Firm Action

Maquet sent an "Urgent - Medical Device Field Correction Notice and Response form dated December 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed of the issues and provided corrective actions. Customers are asked to completed the attached response form in order to return to 1-973-629-1518, or via email to [email protected]. Questions can be directed 1-800-777-4222, option 3, Monday through Friday 8 am-6 pm. EST.

Root Cause

Other

Distribution Pattern

Worldwide Distribution- Nationwide Distribution including Puerto Rico.

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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