Guider Softip XF Guide Catheter recalled for incorrect tip curve shape
Boston Scientific Corporation is recalling 326 units of Guider Softip XF Guide Catheters due to certain lots being 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 a Class II FDA recall of a cardiac guide catheter with an incorrect tip curve shape that does not match labeled specifications. No illnesses or injuries have been reported. The device qualifies as a risk-of-harm product given its critical role in cardiac procedures, placing it at Score 3 per the rubric criterion for defective products without reported injury.
Plain-English summary
Guider Softip XF Guide Catheters (catalog number M003100630), manufactured by Boston Scientific Corporation, are being recalled. The recall covers 326 units distributed in Indiana with affected lot numbers 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, and 27219434.
Certain lots of these cardiac guide catheters were distributed with an incorrect tip curve shape. The tip curve shape on the distributed products does not match the labeled specifications for the device.
Healthcare providers and facilities that received the recalled lot numbers should immediately identify and quarantine the affected units. Contact Boston Scientific Corporation to arrange for return or replacement of the affected devices. The recalled devices should not be used.
The recalled product
- Product
- Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 326
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 (8)
- GTIN 08714729283515
- Lot/Batch Numbers: 25651754
- 25651753
- 25761245
- 26059691
- 26409982
- 26599707
- 27219434 ****recall letter has more lot numbers****
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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