Datascope Corporation recalls Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
- Recall date
- August 5, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1686-2022
- FDA classification
- Class II
- Brand / firm
- Datascope Corporation
- Sold / distributed
- 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.
Why it was recalled
Certain lots containing undersized dilator.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
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