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.
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: 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
- Hazard
- tip-curve-mismatch
- 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 (16)
- GTIN 08714729283539
- Lot/Batch Numbers: 26409983
- 26590809
- 27450921
- 27780468
- 25715223
- 25761249
- 25964483
- 25964484
- 26138315
- 26409984
- 26891844
- 27558598
- 27780463
- 28632343
- 28737896
Distribution
Distributed nationwide across the United States.
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