Guider Softip Guide Catheters recalled for incorrect tip curve shape
Boston Scientific is recalling certain Guider Softip Guide Catheters due to incorrect tip curve shape that differs from the label. The recall affects 1170 units distributed in Indiana.
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 a structural defect (incorrect tip curve shape). No illnesses or injuries have been reported. It meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling Guider Softip Guide Catheters (5F PRE-SHAPED 40 100CM, Catalog number M003101620) distributed in Indiana because certain lots have an incorrect tip curve shape that differs from the labeled specification.
The recall affects 1170 units. The affected lot numbers are 26409983, 26590809, 27450921, 27780468, 25715223, 25761249, 25964483, 25964484, 26138315, 26409984, 26891844, 27558598, 27780463, 28632343, and 28737896.
The recalled product
- Product
- Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,170
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 (16)
- GTIN 08714729283539
- Lot/Batch Numbers: 26409983
- 26590809
- 27450921
- 27780468
- 25715223
- 25761249
- 25964483
- 25964484
- 26138315
- 26409984
- 26891844
- 27558598
- 27780463
- 28632343
- 28737896
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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