Guider Softip XF Guide Catheter Recalled for Incorrect Tip Curve Shape
Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from labeled specifications, affecting 1,086 units 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 an FDA Class II medical device recall of a cardiac guide catheter with a functional defect. Although no illnesses or injuries have been reported, the incorrect tip curve shape could affect device performance in a high-risk application, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific is recalling certain lots of the Guider Softip XF Guide Catheter, a cardiac guide catheter. The recalled units were distributed with a tip curve shape that differs from the labeled specifications.
The affected product was distributed in Indiana. The recalled lot numbers are 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, and 28811944. A total of 1,086 units with GTIN 08714729283508 are being recalled.
When a cardiac guide catheter has an incorrect tip curve shape, it may not perform as intended during use. Healthcare providers with devices from the affected lots should verify lot numbers against this notice.
The recalled product
- Product
- Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiac
- Hazard
- catheter-shape-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 (17)
- GTIN 08714729283508
- Lot/Batch Numbers: 26277195
- 26891778
- 25715235
- 25715236
- 25761247
- 25761248
- 26059690
- 26277194
- 26599706
- 27170548
- 27444248
- 27516585
- 28057178
- 28584686
- 28595475
- 28811944
Distribution
Distributed nationwide across the United States.
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