Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31,… Recall
Issued September 6, 2023 · Datascope Corp.
In September 2023, Datascope Corp. recalled the Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The HHE also identified hardware issues related to these alarms.
What you should do
- 1 Stop using Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31,… 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.
Recall details
- Brand
- Datascope Corp.
- Category
- Health
- Recall date
- September 6, 2023
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution.
- Recall number
- FDA-Z-2435-2023
- 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.