Recall Z-2917-2026 ยท DQX Wire, Guide, Catheter
Galt Medical Corporation
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
| Date | Aug 7, 2026 (initiated Jun 26, 2026) |
| Status | Open, Classified |
| Reason | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. |
| Root cause | Under Investigation by firm |
| Action | On July 30, 2026, Galt Medical Issued a 4th iteration of the Urgent: Medical Device Recall Notification via Email expanding the affected lots. The initial notification was issued on June 26, 2026 via Email, 2nd notification issued on June 30, 2026 and 3rd notification issued on July 9, 2026. Galt Medical asked consignees to take the following actions 1. Discontinue use and distribution of the products with the affected lot numbers. 2. Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers. 3. Ensure all applicable personnel within the vicinity o |
| Quantity | 114,260 kits |
| Distribution | US Nationwide distribution in the state of MN. |
| FDA record | Open on fda.gov |