Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535
FDA device recall Z-1362-2026 · posted 2026-02-13 · Open, Classified
Recall details
- Recalling firm
- Wilson-Cook Medical Inc.
- Reason for recall
- Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
- Action taken
- On 12/18/2025, the firm priority mailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that the firm is removing Teslatome Bipolar Sphincterotomes from the market because they are nonconforming. Customers are instructed to: 1. Examine inventory immediately to determine if you have affected devices. Immediately cease use of the affected devices and quarantine all affected devices. 2. Return the affected devices to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a credit. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected devices on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. For questions, contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KNS
- Quantity affected
- 153
- Distribution
- U.S. Distribution to states of: CA, CO, IN, and NC.
- Date initiated
- 2025-12-18
- Date posted
- 2026-02-13
- Location
- Winston Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (K243568) | Wilson-Cook Medical, Inc. | 2025-01-17 |