Cardiac guide catheters recalled for incorrect tip curve
Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device (cardiac guide catheter) with a manufacturing defect. No injuries or hospitalizations have been reported. Per the severity rubric, risk-of-harm products with no reported adverse events receive a score of 3.
Plain-English summary
Boston Scientific Corporation is recalling the Guider Softip Guide Catheter (model H965100460), a cardiac guide catheter. Certain lots of this device were distributed with a tip curve shape that differs from the labeled specifications.
Approximately 2,245 units are affected by this recall. Facilities should check their inventory against the affected lot numbers listed in the FDA recall notice (Z-0012-2024) to determine if they received any recalled units.
If your facility has any of the recalled catheters, contact Boston Scientific Corporation or the FDA for instructions on returning or replacing the affected devices.
The recalled product
- Product
- Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- design-defect
- incorrect-tip-curve
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 08714729202509
- Lot/Batch Numbers: 26059397
- 26338716
- 25822912
- 25822914
- 25822915
- 25822916
- 26059642
- 26584704
- 26585219
- 26745658
- 26745659
- 26891768
- 27177893
- 27412261
- 27504202
- 27568860
- 27754498
- 27816607
- 28100259
Distribution
Distributed nationwide across the United States.
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