Guide Catheter Recalled for Incorrect Tip Curve Shape
Stryker Neurovascular identified that certain Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from the label. No injuries or illnesses have been reported.
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: FDA Class II recall involving a structural deviation (incorrect tip curve shape) in a cardiac interventional device. While no illnesses or injuries have been reported, the hazard represents a potential risk-of-harm to patients undergoing cardiac procedures where the catheter tip shape is critical to proper function.
Plain-English summary
Stryker Neurovascular has identified that certain lots of Guider Softip XF Guide Catheters (7F 100CM, Catalog number M003101470) were distributed with an incorrect tip curve shape that differs from the labeled specification. The product is manufactured by Boston Scientific Corporation.
Approximately 828 units were affected and distributed nationwide. The affected lot numbers are: 26746117, 26891819, 27121009, 27435625, 26411755, 26746118, 27435626, 27444224, and 27558596.
Guider Softip Guide Catheters are used in cardiac interventional procedures. A tip curve shape that differs from the labeled specification could affect the catheter's performance during clinical use. No injuries or illnesses related to this issue have been reported.
Healthcare facilities and clinicians should contact Boston Scientific for information regarding the recalled products. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 828
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 (10)
- GTIN 08714729244349
- Lot/Batch Numbers: 26746117
- 26891819
- 27121009
- 27435625
- 26411755
- 26746118
- 27435626
- 27444224
- 27558596 ****letter has more lot numbers than spreadsheet*****
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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Similar recalls
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- HighStryker Neurovascular Recalls Guider Softip XF Guide Catheters
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