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Maxon GMMT-961Recalls & 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
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884523004588), received between Aug 11, 2022 and Aug 11, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 Component1

Patient problems

  • Unintended Radiation Exposure1

Recent adverse event reports

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

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

    ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT, WHEN OPENING THE PACKAGE, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED. AN X-RAY WAS DONE TO RESOLVE THE ISSUE.

    Patient problems: Unintended Radiation Exposure

    MAUDE report 15214025 ↗

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

All SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices →

Sources and updates

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