Maxon 8886 6235-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884523002447), received between Jul 2, 2018 and Dec 30, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE FOR A FRACTURE METACARPAL RIGHT USING THE MAXON 4-0 SUTURE, THE SUTURE BROKE IN THE MIDDLE. THE BREAK OCCURRED WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039518 ↗
• MalfunctionAug 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE NEEDLE WAS HELD WITH HEGAR AND AN ATTEMPT WAS MADE TO PULL OUT THE THREAD, THE THREAD CAME OFF FROM THE NEEDLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164909 ↗
• MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LARGE INTESTINE ANASTOMOSIS, THE NEEDLE DETACHED FROM THE SUTURE. SURGEON TRIED DIFFERENT PACKETS OF THE SAME BOX AND LOT NUMBER BUT ALL HAD THE SAME ISSUE. ANOTHER BOX OF THE SAME SUTURE WAS OPENED AND USED THAT COMPLETED THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405641 ↗
• MalfunctionAug 5, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE SUTURING THE TISSUE OR VESSEL, THE THREE SUTURE THREADS BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370858 ↗
• MalfunctionMar 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835729 ↗
• MalfunctionFeb 9, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD BROKE AT THE HEIGHT OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9685149 ↗
• MalfunctionJan 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CAESARIAN SECTION PROCEDURE, THE DEVICE THREAD BROKE DURING SUTURING. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9544762 ↗
• MalfunctionDec 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE, WHILE THE SURGEON TOOK THE DEVICE OUT OF THE PACKAGE, THE NEEDLE OF THE BOTH SIDES CAME OFF. HENCE, THE PRODUCT WAS NOT USED FOR PATIENT. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9392760 ↗
• MalfunctionJul 2, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING GASTRIC SLEEVE PROCEDURE, THE THREAD BROKE IN RUNNING SUTURING TECHNIQUE. THEY USED A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654370 ↗

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: