Myo/Wire II 040-397Recalls & reported problems
A & E Medical Corporation · SS Suture, 4 per sleeve · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841291102052), received between Apr 29, 2016 and Apr 29, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Unsealed Device Packaging1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2016Unsealed Device Packaging; Unsealed Device Packaging
CUSTOMER RETURNED PRODUCT BECAUSE THEY FOUND THE PRODUCT POUCH (STERILE BARRIER) TO BE UNSEALED. NO PATIENT WAS INVOLVED, OPEN SEAL WAS NOTED DURING PREPARATION FOR PROCEDURE. CUSTOMER RETURNED THE ENTIRE LOT MINUS 4 UNITS THAT WERE REPORTED TO HAVE BEEN DISCARDED BECAUSE THE SEALS WERE NOTED TO BE OPEN.
Patient problems: No Patient Involvement
MAUDE report 5619326 ↗
Other Suture, Nonabsorbable devices
- Myo/Wire II 046-367A & E Medical Corporation · Suture, Nonabsorbable4 reports
- Myo/Wire II 040-308A & E Medical Corporation · Suture, Nonabsorbable2 reports
- Myo/Wire II 040-355A & E Medical Corporation · Suture, Nonabsorbable2 reports
- Myo/Wire II 046-093A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-181A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-062A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 040-365A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-267A & E Medical Corporation · Suture, Nonabsorbable1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page