Cuff, Nerve
FDA adverse event reports and recall history for cuff, nerve (product code JXI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 165
- Deaths
- 0
- Injuries
- 110
- Malfunctions
- 21
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-04-25Open, ClassifiedUnder Investigation by firm
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
The product is brittle and potentially crumbling upon handling or when being removed from its package.
- 2013-05-10TerminatedProcess control
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- 2013-05-10TerminatedProcess control
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
- TerminatedLabeling mix-ups
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
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