TISSIUM SA COAPTIUM Connect Recall
Announced 2026-08-12 · FDA
TISSIUM SA is relabeling COAPTIUM Connect devices to reflect a revised shelf life of 26 months because the current 36-month shelf life is not substantiated by real-time data. Use beyond the validated shelf life may cause perioperative device breakage and render the device unusable, potentially requiring revision surgery. The affected devices were distributed in the US in CA, FL, IL, NJ, OH, and PA, with Lot Numbers 250700041 and 251000032 (Model No NCOCO1510; UDI-DI 03760279380070).
| Brand | TISSIUM SA |
|---|---|
| Product | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A |
| Reason | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery. |
| Severity | moderate |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA. |
| Agency | FDA |
| Recall / campaign no. | Lot Code: Model No NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032 |
WHAT YOU SHOULD DO
- Check your COAPTIUM Connect packaging/labeling to confirm the shelf life is updated to 26 months and identify if your device is from Lot 250700041 or 251000032 (Model NCOCO1510).
- Do not use the device if its shelf life has expired; consult your surgeon or healthcare provider for guidance.
- Contact your healthcare provider for instructions on replacement or next steps related to the recall, and seek updates from the device manufacturer or FDA recall information as needed.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.