Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Guider Softip Guide Catheter (cardiac device) is being recalled because certain units have an incorrect tip curve shape that differs from the label. A total of 116 units have been distributed.
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 (incorrect tip curve shape) affecting a high-risk cardiac application. While no injuries have been reported, the defect could compromise device function and patient safety during interventional procedures, meeting the criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation's Guider Softip Guide Catheter is a cardiac guide catheter used in interventional cardiology procedures. Certain lots of the 5F 100CM Multi-Purpose model (Catalog Number M003101630) are being recalled because they have an incorrect tip curve shape that differs from the shape indicated on the device label.
The defect was identified by Stryker Neurovascular, which observed that the impacted products were distributed with a tip curve shape differing from the labeled specifications. A total of 116 units have been distributed in the United States.
The affected lot numbers are: 25715222, 27762225, and 27780464. Given the cardiac application, the incorrect tip curve shape could affect proper catheter navigation and performance during clinical use.
The recalled product
- Product
- Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 116
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 (4)
- GTIN 08714729283546
- Lot/Batch Numbers: 25715222
- 27762225
- 27780464
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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Similar recalls
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