COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.
What this means for you
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 with theoretical risk of device breakage leading to revision surgery. No reported injuries or illnesses, but risk-of-harm product where injury has not yet been reported per rubric criteria for High severity.
Plain-English summary
TISSIUM SA is recalling COAPTIUM CONNECT, an in situ polymerizing peripheral nerve repair device (Model No NCOCO4010), due to labeling issues with its shelf life. The devices are currently labeled with a 36-month shelf life that is not substantiated by real-time data. The company will re-label affected devices to reflect a revised shelf life of 26 months.
Using a medical device beyond its validated shelf life may result in perioperative breakage of the device, rendering it unusable. The worst-case outcome would be revision surgery. No illnesses or injuries have been reported in connection with this recall.
The recall affects devices distributed in the United States in the states of CA, FL, IL, NJ, OH, and PA. Affected lot numbers include 251000041, 250700048, 260300046, 260400050, and 260300047. UDI-DI 03760279380148 is associated with these lots.
Healthcare facilities and patients using COAPTIUM CONNECT devices should verify the shelf life on their devices. Any device with a 36-month shelf life label should be returned to TISSIUM SA for re-labeling or replacement. Contact the manufacturer for return instructions.
The recalled product
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
- Manufacturer
- TISSIUM SA
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 (7)
- Lot Code: Model No NCOCO4010
- UDI-DI 03760279380148
- Lot Numbers 251000041
- 250700048
- 260300046
- 260400050
- and 260300047
Distribution
Part of a larger recall action
This product is one of 8 recalled by TISSIUM SA 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.
See all 8 products in this recall →Related recalls
Same manufacturer · TISSIUM SA
See all →- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
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- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- ModerateCOAPTIUM CONNECT peripheral nerve repair device recalled due to inaccurate shelf life labeling
FDA (Devices) · 2026-08-12
- ModerateCOAPTIUM CONNECT medical device shelf life recalibration recall
FDA (Devices) · 2026-08-12
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