Maxon 8886 6532-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884523003871), received between Mar 26, 2019 and Dec 19, 2023 — classified as 8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SKIN CLOSURE PROCEDURE, WHEN OPENING THE STERILE PACKING OF THE SUTURE, THE PRODUCT WAS NOT APPLIED TO THE TISSUE. THERE WERE SIX SUTURES LEFT OUT OF THE BOX. THREE SUTURES WERE NOT EVEN ATTACHED TO THE NEEDLE, AND THREE SUTURES DETACHED FROM THE NEEDLE WHEN GRABBING THE NEEDLE WITH THE NEEDLE HOLDER. TO RESOLVE THE ISSUE, A SUTURE FROM ANOTHER BOX WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356181 ↗
• MalfunctionDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SKIN CLOSURE PROCEDURE, WHEN OPENING THE STERILE PACKING OF THE SUTURE, THE PRODUCT WAS NOT APPLIED TO THE TISSUE. THERE WERE SIX SUTURES LEFT OUT OF THE BOX. THREE SUTURES WERE NOT EVEN ATTACHED TO THE NEEDLE, AND THREE SUTURES DETACHED FROM THE NEEDLE WHEN GRABBING THE NEEDLE WITH THE NEEDLE HOLDER. TO RESOLVE THE ISSUE, A SUTURE FROM ANOTHER BOX WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356078 ↗
• MalfunctionDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SKIN CLOSURE PROCEDURE, WHEN OPENING THE STERILE PACKING OF THE SUTURE, THE PRODUCT WAS NOT APPLIED TO THE TISSUE. THERE WERE SIX SUTURES LEFT OUT OF THE BOX. THREE SUTURES WERE NOT EVEN ATTACHED TO THE NEEDLE, AND THREE SUTURES DETACHED FROM THE NEEDLE WHEN GRABBING THE NEEDLE WITH THE NEEDLE HOLDER. TO RESOLVE THE ISSUE, A SUTURE FROM ANOTHER BOX WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355928 ↗
• MalfunctionMar 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE NEEDLE AND THREAD CAME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656843 ↗
• MalfunctionSep 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE NEEDLE WAS TAKEN OUT, THE THREAD AND NEEDLE WERE NOT CONNECTED. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412770 ↗
• MalfunctionNov 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY FOR OPHTHALMIC PTOSIS, AT THE TIME OF WOUND CLOSURE, WHEN THE SUTURE WAS HELD WITH A NEEDLE HOLDER, THE THREAD CAME OFF. A NEW SUTURE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760345 ↗
• MalfunctionJul 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE ON AN OPEN ABDOMINAL BLEPHAROPTOSIS, THE DEVICE CAME OFF THE SWAGE SO IT COULD NOT BE SUTURED. ANOTHER NEW SUTURE WITH SAME LOT NUMBER WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12168201 ↗
• MalfunctionMar 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE WAS DETACHED FROM THE NEEDLE ONCE THE PACKAGING WAS OPENED.

  Patient problems: No Information

  MAUDE report 8451594 ↗

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: