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Maxon GMM-806LRecalls & reported problems

Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant

All models of Maxon (114)

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

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 10884521114906), received between Apr 16, 2020 and Apr 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionApr 16, 2020Break; Break

    ACCORDING TO THE REPORTER, IN THE PROCESS OF BRINGING SOFT TISSUES CLOSER TOGETHER DURING OPEN RIGHT HEMICOLECTOMY PROCEDURE, THE THREAD OF THE DEVICE WAS ALREADY BROKEN FROM THE ORIGINAL PACKAGING. THE LOOP WAS DONE MANUALLY. NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9969682 ↗

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