Boston Scientific Corporation 2023-10-11 Health serious FDA
Health · FDA · Recall #FDA-Z-0014-2024
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac… Recall
Issued October 11, 2023 · Boston Scientific Corporation
In October 2023, Boston Scientific Corporation recalled the Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac…, a serious 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
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
What you should do
- 1 Stop using Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation 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
- Boston Scientific Corporation
- Category
- Health
- Recall date
- October 11, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the state of Indiana.
- Recall number
- FDA-Z-0014-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.