Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling 1004 units of Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from the 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 an FDA Class II recall of a cardiac guide catheter with an incorrect tip curve shape. While no illnesses or injuries have been reported, the shape discrepancy poses a risk of harm in vascular procedures if the incorrect geometry affects catheter placement or causes vessel trauma.
Plain-English summary
Boston Scientific Corporation is recalling certain lots of Guider Softip Guide Catheters (Catalog number M003101430), a cardiac guide catheter used in interventional procedures. The recall affects 1004 units.
The catheters from the affected lots were distributed with an incorrect tip curve shape that differs from the labeled specifications. This discrepancy between the actual product geometry and documented design specifications was identified.
Affected lot/batch numbers are: 27241919, 27516638, 27780467, 27780470, 28065090, 26138318, 26891812, 28676781, 28595471, 28676782, 28886804, and 28910751. The recalled products were distributed in the United States, including Indiana.
The recalled product
- Product
- Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 1,004
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 (13)
- GTIN 08714729244301
- Lot/Batch Numbers: 27241919
- 27516638
- 27780467
- 27780470
- 28065090
- 26138318
- 26891812
- 28676781
- 28595471
- 28676782
- 28886804
- 28910751
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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