Datascope Corp. 2023-08-02 Health serious FDA
Health · FDA · Recall #FDA-Z-2217-2023
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide… Recall
Issued August 2, 2023 · Datascope Corp.
In August 2023, Datascope Corp. recalled the SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.
What you should do
- 1 Stop using SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide… 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
- August 2, 2023
- Units affected
- Not reported
- Sold at
- Domestic distribution nationwide. International distribution worldwide.
- Recall number
- FDA-Z-2217-2023
- 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.