Maxon 8886 6267-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884523002614), received between Dec 13, 2018 and Mar 18, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 18, 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.

• MalfunctionMar 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A OPEN HERNIA REPAIR PROCEDURE, PRIOR TO PATIENT USE, THE NEEDLE DETACHED FROM THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634673 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HERNIA PROCEDURE, A NEEDLE DETACHMENT OCCURRED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555934 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE REMOVING FROM RETAINER PRIOR TO PATIENT USE, THE NEEDLE DETACHED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439443 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE DETACHED WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24426685 ↗
• MalfunctionFeb 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HERNIA REPAIR, THE NEEDLE DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233824 ↗
• MalfunctionMar 6, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE FOR A FACELIFT, WHEN THE FACELIFT FLAP WAS ON THE PATIENT'S LEFT SIDE, THE SURGEON USED THE 3-0 SUTURE TO CLOSE THE FACELIFT FLAPS, AND THE SURGEON THREW HIS SQUARE KNOTS AND THEN SLIDES THE KNOW OVER WITH FORCEPS. WHEN THE SURGEON GRABS BELOW THE KNOT WITH FORCEPS AND SLIDES THE KNOT OVER THE STRAND BREAKS THE KNOT AT THE FORCEPS LOCATION. IT WAS RESULTED MULTIPLE TIMES WITH A 3-0 STRAND AS WELL AS A 2-0 STRAND. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 16486446 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE STRAND BROKE OFF AT THE NEEDLE AND SOMETIMES, WHEN THE NURSE OPENS THE PACKAGE, THE STRAND IS NO LONGER ATTACHED TO THE NEEDLE. NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460688 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CUSTOMER STATED THAT THE THREAD IS BROKEN OFF AT THE NEEDLE AND SOMETIMES EVENT THE NURSE WILL OPEN THE PACKAGE AND THE STRAND IS NOT ATTACHED TO THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460281 ↗
• MalfunctionDec 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, OPEN HERNIA PROCEDURE, THE SUTURE WAS BREAKING OFF FROM THE NEEDLE. THEY USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8159971 ↗

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: