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Syneture US1667Recalls & reported problems

Covidien LP · Custom Suture Pack,(4) 88863256-41;(2) 88866307-71;(1) 88868679-01;(2) S-193;(1) S-195;(2) S-608;(1) VP-37-M-X;(2) VP-521-X;(1) VP-705-MX;(1) VP-706-MX · Class 2

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 10884521196155), received between May 11, 2022 and May 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BY PASS (CABG) PROCEDURE, THERE WAS NO PROBLEM WITH THE FIRST DEVICE. BUT ON THE SECOND DEVICE, THE NEEDLE CAME OFF. TO RESOLVE THE ISSUE, A NEW DEVICE OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14350652 ↗

Other Suture kit devices

All Suture kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.