Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling certain lots of Guider Softip cardiac guide catheters because they were distributed with an incorrect tip curve shape that doesn't match the product label. Approximately 3,738 units were affected.
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: FDA Class II recall of a cardiac guide catheter with a confirmed manufacturing defect: certain units have an incorrect tip curve shape that differs from the labeled specification. The recall notice does not document any reported illnesses or adverse events. The combination of Class II classification, a confirmed defect in a high-risk medical device, and absence of reported adverse events warrants High severity (Score 3).
Plain-English summary
Boston Scientific Corporation is recalling certain lots of its Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, a cardiac guide catheter (catalog number M003101460). The affected units were distributed with a tip curve shape that differs from the labeled tip curve shape.
The mismatch between the physical device and its labeled specification constitutes the reported defect. A guide catheter's tip curve is essential to its design and intended function during cardiac procedures.
Approximately 3,738 units were distributed. The affected lot/batch numbers are: 26059697, 26339267, 26339269, 26590800, 26746116, 26891817, 26891818, 27065537, 27288435, 27535145, 27592321, 28132917, 28384670, 25715225, 25715226, 26059695, 26339266, 26339268, 26498391, 26590801, 26746114, 26746115, 26891816, 28632177, 27081948, 27254932, 27280217, 27435623, 27558595, 27592320, 27767765, 27824570, 28115146, 28738180, 28384671, 28632176, 28632178, 28632179, 28737899, 28738181, 28886805, 28886806, 28886807, 29113162, 28795500.
Do not use affected devices in patient procedures. Contact Boston Scientific Corporation or your device supplier for guidance on replacement or return of affected units.
The recalled product
- Product
- Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- incorrect-tip-curve
- device-defect
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 08714729244332
- Lot/Batch Numbers: 26059697
- 26339267
- 26339269
- 26590800
- 26746116
- 26891817
- 26891818
- 27065537
- 27288435
- 27535145
- 27592321
- 28132917
- 28384670
- 25715225
- 25715226
- 26059695
- 26339266
- 26339268
- 26498391
Distribution
Distributed nationwide across the United States.
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