Reported Oct 11, 2023 · Ongoing
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Boston Scientific 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: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
- Lot codes and dates
- GTIN 0871472920247
- Lot/Batch Numbers
26034355260343582576134626034356260348322603483326277184262771852659962026599621265996242674564826745649268912962708194127081942270819432710334627645560276963572775449727779955277804692799630628049141283846362838463728502666285026672867657728676578288411722884117328841174288411752884117628910752289107542627718626411753265996222659962326745647268912972689149827081944270819452884117728955941
- Amount recalled
- 4426 units
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
- IN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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