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Maxon 8886 6221-31Recalls & 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
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523002379), received between Dec 18, 2017 and Feb 20, 2020 — classified as 4 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
  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient3
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PRODUCT WAS NOT USED ON THE PATIENT, ON THE FIRST STITCH, WHEN OPENING, IT WAS FOUND THAT BOTH NEEDLES CAME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9733137 ↗
  • MalfunctionNov 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THEY TRIED TO PULLED THE THREAD OUT FROM FIRST PACKET, THE NEEDLE DISENGAGED FROM THE NEEDLE SWEDGE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8034618 ↗
  • MalfunctionJun 15, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING PROXIMAL PANCREATICODUODENECTOMY, THE DEVICE NEEDLE DETACHED AND PART OF IT FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7607177 ↗
  • MalfunctionDec 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, THE DEVICE'S NEEDLE CAME OFF FROM THE THREAD. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE AND RESOLVE THE ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7125924 ↗

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

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