Maxon 8886 6608-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884523003956), received between Jan 2, 2018 and Apr 21, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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.

• MalfunctionApr 21, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHILE REMOVING FROM THE RETAINER, THE NEEDLE DETACHED FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941817 ↗
• MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF AN OPEN PROCEDURE, WHILE PREPARING AT THE BEGINNING OF SURGERY, PRIOR TO PATIENT USE THROUGH A SIMPLE CONTINUOUS SUTURE TECHNIQUE, THE NEEDLE AND THREAD OF ONE OR TWO SUTURES BROKE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058370 ↗
• MalfunctionSep 17, 2021Break; Break

  ACCORDING TO THE REPORTER, THE THREAD OF THE REPORTED DEVICES BROKE.

  Patient problems: Insufficient Information

  MAUDE report 12487716 ↗
• MalfunctionAug 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN REMOVED FROM THE PACKAGING AND LOADED ON THE NEEDLE HOLDER, NEEDLES DETACHED FROM 11 SUTURES WITHOUT EXCESSIVE FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372914 ↗
• MalfunctionJul 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EXCISION OF BASAL CELL SKIN CANCER, WHEN THE SUTURE PACK WAS OPENED, IT WAS FOUND OUT THAT THE NEEDLE DETACHED FROM THE SUTURE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132479 ↗
• MalfunctionAug 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE WHEN ATTEMPTING TO TAKE THE PRODUCT OUT OF THE PACKAGE, THE NEEDLE AND THREAD DISENGAGED. A NEW PRODUCT WAS USED AND THERE WAS NO PROBLEM. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8900284 ↗
• MalfunctionJul 16, 2019Break; Break

  ACCORDING TO THE REPORTER, ON AN OPEN DERMATOLOGY PROCEDURE, THE THREAD OF 2 SUTURES BROKE DURING CLOSURE. THERE WAS NO PATIENT INJURY. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795283 ↗
• MalfunctionJun 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HEART VALVE REPLACEMENT, THE NEEDLE DETACHED FROM THE THREAD WITHOUT EXCESSIVE FORCE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7591895 ↗
• MalfunctionJan 2, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE THREAD BROKE INTO PIECES. NOTHING FELL INTO THE CAVITY. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7158550 ↗

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: