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Maxon 8886 6229-53Recalls & 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
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523001792), received between Jan 4, 2018 and Jun 29, 2021 — classified as 1 injury, 2 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 16, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Break1
  • Detachment Of Device Component1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • Radiation Exposure, Unintended1

Recent adverse event reports

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

  • MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE FREE FROM THE STRAND.

    Patient problems: Insufficient Information

    MAUDE report 12089839 ↗
  • MalfunctionJan 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE BROKE FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11228619 ↗
  • InjuryJan 4, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MID URETHRAL SLING PLACEMENT, CYSTOSCOPIC COLPOCLEISIS AND DILATION AND CURETTAGE, TWO DEVICES WERE USED. TIPS OF THE NEEDLE BROKE OFF ON BOTH DEVICE AND WERE ASSUMED LEFT IN PATIENT. X-RAY WAS DONE AND NEITHER TIP WERE FOUND. PATIENT IS ALIVE.

    Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

    MAUDE report 7164187 ↗

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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