Cardiac Guide Catheters Recalled for Incorrect Tip Curve Shape
Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 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 an FDA Class II recall for a medical device defect with no reported illnesses or injuries. The manufacturing defect (incorrect tip curve shape) presents a risk of harm to patients during cardiac catheterization procedures, warranting a High severity classification.
Plain-English summary
Guider Softip Guide Catheter 8F 90CM (Catalog number H965100480), manufactured by Boston Scientific Corporation, has been recalled due to a manufacturing defect. The affected catheters were manufactured with an incorrect tip curve shape that differs from the labeled specifications.
Approximately 17,436 units of the recalled catheters were distributed in Indiana. The defect affects the physical shape of the catheter tip, which could impact its performance and safety when used in cardiac procedures.
Healthcare providers and patients in possession of affected lots should immediately cease use of these catheters. Consumers should contact Boston Scientific Corporation to arrange for return or replacement of the affected units. A complete list of affected lot numbers is available from the FDA.
The recalled product
- Product
- Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 17,436
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 (20)
- GTIN 08714729202523
- Lot/Batch Numbers: 25651745
- 25651749
- 25651755
- 25761258
- 25914835
- 25915125
- 25964541
- 26138808
- 26138818
- 26138819
- 26338718
- 26339260
- 26339261
- 26498387
- 26726579
- 26726621
- 26726622
- 26726624
- 26746104
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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