Reported Sep 14, 2022 · Ongoing
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
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?
- Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
- Lot codes and dates
Code information reads "UDI-DILot NoFinished Goods Part No.": 1060756710859930001707090884-00-0019-231060756710859930001826110884-00-0019-231060756710859930002020830884-00-0019-23
- Amount recalled
- 10,427 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Certain lots containing undersized dilator.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Datascope Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.