Maxon 8886620731-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521757790), received between Apr 8, 2021 and Aug 26, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Detachment of Device or Device Component

  According to the reporter, during a procedure, prior to patient use, the needle detached away from the suture while being loaded on to the needle holder. A new suture was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458949 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE OF A SUTURE CAME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217944 ↗
• MalfunctionJun 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE DETACHED FOR THE TWO PACKETS WHEN BEING PULLED OUT FROM THE RETAINER AND PREPARING FOR SUTURING. A THIRD PACKET WAS USED AND THERE WAS NO PROBLEM WITH THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172638 ↗
• MalfunctionJun 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE DETACHED FOR THE TWO PACKETS WHEN BEING PULLED OUT FROM THE RETAINER AND PREPARING FOR SUTURING. A THIRD PACKET WAS USED AND THERE WAS NO PROBLEM WITH THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172567 ↗
• MalfunctionJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DERMAL SUTURING, WHEN CLOSING THE WOUND/INCISION, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265037 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DEEP DOUBLE CESAREAN SECTION PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE WHEN THE PACKAGE OF THE PRODUCT WAS OPENED WHILE SUTURING THE DERMIS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274793 ↗
• MalfunctionMar 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND SUTURE CAME OFF. THE DEVICE WAS NOT USED. ANOTHER DEVICE FROM THE SAME LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591871 ↗
• MalfunctionDec 21, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN AN ATTEMPT WAS MADE TO REMOVE THE SUTURE FROM THE PACKET DURING THE PREPARATION STAGE, THE THREAD WAS BROKEN. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022652 ↗
• MalfunctionFeb 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN APPENDECTOMY, WHEN THE SURGEON WAS GOING TO CLOSE, THE NEEDLE DETACHED FROM THE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534777 ↗
• MalfunctionNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE IN A NISSEN FUNDOPLICATION, WHEN THE SURGEON BEGAN SUTURING AND, ON THE FIRST BITE, WHEN THE SURGEON PULLED ON IT, THE NEEDLE DETACHED FROM THE STRAND. THE SURGEON DIDN¿T APPLY MORE TENSION THAN USUAL. SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805560 ↗
• MalfunctionApr 8, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING ILEAL-URETERAL ANASTOMOSIS, SIX INTERRUPTED SUTURES WERE PLACED. WHEN THE SURGEON CHECKED THE ANAS TOMOSIS LATER IN CASE, THREE OF THE SUTURES HAD UNRAVELED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634086 ↗

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: