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Maxon 8886 6261-31Recalls & 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
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 10884523002577), received between Oct 4, 2019 and Dec 14, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component4
  • Break1

Patient problems

  • No Consequences Or Impact To Patient3
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 14, 2022Break; Break

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC WHIPPLE PROCEDURE, WHILE USING THE SUTURE TO DO ANASTOMOSES, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

    Patient problems: Insufficient Information

    MAUDE report 15976275 ↗
  • MalfunctionOct 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS NOT CONNECTED WITH SUTURE. A NEW SUTURE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15597398 ↗
  • MalfunctionMay 26, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN THE SUTURE PULLED OUT OF THE PACKAGE, BOTH NEEDLE AND THREAD BROKE. REPLACED WITH ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10086073 ↗
  • MalfunctionDec 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD AFTER UNPACKING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9442663 ↗
  • MalfunctionOct 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SUTURE NEEDLE AND THREAD SEPARATED WHEN THE PACKAGE WAS OPENED. REPLACED WITH ANOTHER PACK OF SUTURE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9158605 ↗

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:

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Sources and updates

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