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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 2,245
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
Part of a larger recall action
This product is one of 16 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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