Wilson-Cook Medical Recalls Teslatome Bipolar Sphincterotomes Over Current Path Risk
Wilson-Cook Medical Inc. is recalling 153 Teslatome Bipolar Sphincterotomes due to a potential void in the material separating the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device used in ERCP procedures. Per the rubric, FDA Class II recalls with potential for serious health consequences during medical procedures are classified as Severe (score 4).
Plain-English summary
Wilson-Cook Medical Inc. is recalling 153 units of the Teslatome Bipolar Sphincterotomes, including REF TESLA-B2535-260 (Model G60784) and REF TESLA-B2535-450 (Model G60785). These medical devices are used for cannulation of the ductal system and for sphincterotomy, and when preloaded, they also aid in bridging difficult strictures during ERCP. The recall is classified as FDA Class II.
The reason for the recall is that the product may contain a void in the material that separates the wire guide and cutting wire lumens. This defect may cause an inappropriate path of current during cutting, which could affect the safety or effectiveness of the device during use.
The recalled devices were distributed in the U.S. to the states of CA, CO, IN, and NC. Healthcare facilities and professionals who received the affected devices should follow their organization's recall procedures and contact Wilson-Cook Medical Inc. for replacement or further instructions.
No illnesses or injuries have been reported in connection with this recall. Healthcare providers should immediately quarantine any affected units and contact Wilson-Cook Medical Inc. for return or replacement. Consumers or patients with questions should consult their healthcare provider.
The recalled product
- Product
- Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If…
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 153
Distribution
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