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Datascope Corporation recalls Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Recalled September 14, 2022 · FDA recall Z-1686-2022 · Datascope
Hazard
Certain lots containing undersized dilator. · FDA Class II
Units
10,427 units
Sold at
Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Description
Certain lots containing undersized dilator.
Product
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Manufacturer(s)
Datascope Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →