COAPTIUM CONNECT peripheral nerve repair device recalled due to inaccurate shelf life labeling
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a minor labeling error regarding shelf life accuracy. Per the rubric, minor labeling errors qualify for a moderate severity rating.
Plain-English summary
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its originally stated shelf life of 36 months was not supported by real-time data. The manufacturer, TISSIUM SA, will relabel devices to reflect a revised shelf life of 26 months. Using the device beyond its validated shelf life may cause perioperative breakage, potentially requiring revision surgery.
Consumers should follow the updated labeling instructions and ensure proper handling according to the new shelf life specification. The recall affects nationwide distribution across multiple states including California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
The recalled product
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
- Manufacturer
- TISSIUM SA
- Hazard
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 (9)
- Lot Code: Model No NCOCO3010
- UDI-DI 03760279380117
- Lot Numbers 250700045
- 251000040
- 251000036
- 251000037
- 251000039
- 251000035
- and 251000064
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
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- ModerateCOAPTIUM CONNECT medical device shelf life recalibration recall
FDA (Devices) · 2026-08-12
- 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
FDA (Devices) · 2026-08-12
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