Reported May 31, 2017 · Terminated
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number:…
Datascope Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datascope Corporation · 15 Law Dr · Fairfield, NJ · 07004-3206
Is this the product you have?
- SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿
- Product Code/Part Number0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle
- Lot codes and dates
3000045153000043376 3000040272 3000038372
- added lot numbers3000043374 and 3000045513
- Amount recalled
- 996 UNITS
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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