Datascope Corp. 2023-03-15 Health serious FDA
Health · FDA · Recall #FDA-Z-1230-2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75,… Recall
Issued March 15, 2023 · Datascope Corp.
In March 2023, Datascope Corp. recalled the Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
What you should do
- 1 Stop using Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Datascope Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Datascope Corp.
- Category
- Health
- Recall date
- March 15, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide. Global Distribution.
- Recall number
- FDA-Z-1230-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Datascope Corp. has 7 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.