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Caprosyn UC-214Recalls & reported problems

Covidien LP · Monofilament Absorbable Suture,CV-23,1x Violet Strand · Class 2 · Implant

All models of Caprosyn (45)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521035119), received between Jun 7, 2018 and May 3, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component3
  • Break1
  • Component Missing1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 3, 2023Component Missing; Component Missing

    ACCORDING TO THE REPORTER, DURING THE TOOTH REMOVAL, THE NEEDLE HAS COME OFF DURING USE AT LEAST FROM SEVEN SUTURE THREADS. IT WAS ALSO MENTIONED THAT ON ONE THREAD, IT DID NOT HAVE ANY NEEDLE AT ALL. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16861063 ↗
  • MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING THE TOOTH REMOVAL, THE NEEDLE HAS COME OFF DURING USE AT LEAST FROM SEVEN SUTURE THREADS. IT WAS ALSO MENTIONED THAT ON ONE THREAD, IT DID NOT HAVE ANY NEEDLE AT ALL. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16861015 ↗
  • MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING TOOTH REMOVAL, WHEN SUTURING, THE NEEDLE HAD COME OFF FROM THE SUTURE THREAD. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16860098 ↗
  • MalfunctionFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME OFF THE THREAD WHILE SUTURING. THERE WAS NO PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8315313 ↗
  • MalfunctionJun 7, 2018Break; Break

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER THE FIRST THROW, THE DEVICE THREAD BROKE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7578312 ↗

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

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Sources and updates

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