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Terminated

SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.

FDA Recall Z-2164-2017 · Posted None

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSP
Date Initiated2017-04-12
Date Terminated2020-01-28
Product Quantity996 UNITS

Reason for Recall

Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.

Firm Action

Getinge notified their customers with a recall letter/return response form via Fed Ex on 4/12/2017. Getinge notified their customers again through an expansion on 10/16/2017.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDatascope Corp. · 2013-12-12

Official Source

View FDA Recall →

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

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