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Syneture US1716Recalls & reported problems

Covidien LP · Custom Suture Pack, (2) 88863090-71, (3) 88863157-51, (3) 88863256-51, (4)88863271-31, (1) 88864705-01V, (1) 88864719-21V, (1) 88864750-31V, (1) 88864750-41V, (2) 88866269-61, (1) 88866618-51, (2) CN-792, (1) S-317, (3) VP-703-X, (3) VP-900-X, (1) VS-845 · 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 10884521592964), received between Jul 30, 2019 and Jul 30, 2019 — 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 Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, ON A THIGH LIFT PLASTICS PROCEDURE, 8-10 MINUTES INTO THE PROCEDURE USING THE SUBCUTANEOUS CLOSURE SUTURING TECHNIQUE, THE NEEDLE DETACHED FROM THE SUTURE AFTER TWO TO THREE PASSES. IT WAS STATED THAT FOUR SUTURES WERE OPENED AND THE SAME ISSUE OCCURRED. THE STRAND WERE TIED AND ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8843389 ↗

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.