Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape
Boston Scientific is recalling Guider Softip Guide Catheters from certain lots because the tip curve shape does not match the labeled specification. No illnesses or injuries have been reported.
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: FDA Class II recall of a risk-of-harm medical device (cardiac catheter) with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score at Level 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling the Guider Softip Guide Catheter (catalog number H965100430), a cardiac guide catheter. The recall affects certain manufacturing lots with an incorrect tip curve shape that differs from the labeled specifications. Approximately 4,426 units are involved in the recall.
The affected catheters were distributed in the United States. Fifty-one manufacturing lot numbers are affected, including lot numbers 26034355, 26034358, and 25761346, among others, as detailed by the FDA.
Healthcare providers and facilities should stop using affected lots immediately and contact Boston Scientific for guidance on replacement or return. Patients who received these catheters during cardiac procedures should contact their healthcare provider.
No illnesses or injuries have been reported in association with this defect.
The recalled product
- Product
- Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 4,426
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 0871472920247
- Lot/Batch Numbers: 26034355
- 26034358
- 25761346
- 26034356
- 26034832
- 26034833
- 26277184
- 26277185
- 26599620
- 26599621
- 26599624
- 26745648
- 26745649
- 26891296
- 27081941
- 27081942
- 27081943
- 27103346
- 27645560
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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