Cardiac Guide Catheter Recalled Due to Incorrect Tip Curve Shape
Boston Scientific recalls certain Guider Softip Guide Catheters with incorrect tip curve shapes that differ from labeled specifications. Approximately 8,475 units were distributed nationwide.
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 medical device with a manufacturing defect in a high-risk cardiac application where the product physically differs from its labeled specifications. While no illnesses or injuries have been reported, the product presents a risk of harm as an invasive vascular device, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling certain lots of Guider Softip Guide Catheters (Catalog number H965100440, 8F PRE-SHAPED 40 90CM) due to a manufacturing defect affecting the product's tip curve shape.
The affected products were distributed with a tip curve shape that differs from the labeled tip curve shape. This discrepancy between the actual product and its labeled specifications constitutes the basis for the recall.
Approximately 8,475 units were distributed nationwide. Multiple lot numbers are affected as documented in the FDA recall notice.
The recalled product
- Product
- Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 8,475
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 08714729202486
- Lot/Batch Numbers: 25651714
- 25651716
- 26034835
- 26034836
- 26034839
- 25651712
- 25651713
- 25651715
- 25651717
- 25651718
- 25651719
- 26034834
- 26034837
- 26034838
- 26059640
- 26059641
- 26138712
- 26338710
- 26338711
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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