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Maxon 8886 6219-43Recalls & reported problems

Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant

All models of Maxon (114)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523002362), received between Sep 17, 2018 and Jun 1, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K990951); they may or may not involve this specific model.

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

  • Detachment of Device or Device Component2
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND SUTURE WERE DISCONNECTED WHEN THE PACKAGE WAS OPENED. ANOTHER NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11916327 ↗
  • MalfunctionMar 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, PRIOR TO THE FIRST STITCH DURING A PROCEDURE , DETACHABLE THREAD CAME OFF ON ITS OWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Patient problems: No Information

    MAUDE report 9883629 ↗
  • MalfunctionSep 17, 2018Break; Break

    ACCORDING TO THE REPORTER, WHEN PULLING THE SUTURE OUT OF THE PACKAGE, THE SUTURE BROKE. THE EVENT OCCURRED IN USE FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7880788 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990951. One submission often covers many models, so check the product and lot details in each record.

  • Z-2542-2017 · May 3, 2017 · Terminated
    Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number:

Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page