Maxon 8886 6207-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10884523002263), received between Jul 21, 2017 and Jan 8, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (35 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD NEEDLE DETACHMENT.

  Patient problems: Insufficient Information

  MAUDE report 24014575 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD, WHICH HAPPENED TWICE. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697851 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD. IT OCCURRED ON 11 SUTURES. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697847 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD. IT OCCURRED ON 11 SUTURES. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697846 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD. IT OCCURRED ON 11 SUTURES. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697841 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD, WHICH HAPPENED TWICE. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697834 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD. IT OCCURRED ON 11 SUTURES. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697819 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD, WHICH HAPPENED TWICE. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697818 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED AND THE NEEDLE HAD COME OFF THE THREAD. THE ISSUE OCCURRED ON 11 SUTURES. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690926 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN ILEOSTOMY REPOSITIONING PROCEDURE, AFTER OPENING THE PACKAGING, THE SUTURE WAS USED, AND THE NEEDLE HAD COME OFF THE THREAD. THE ISSUE OCCURRED ON 11 SUTURES. ANOTHER SUTURE PACKAGE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689007 ↗
• MalfunctionNov 4, 2023Device Slipped; Patient-Device Incompatibility; Device Slipped; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD KNOTTED AND SLIPPED OFF. THE PATIENT DEVELOPED A KNOT REACTION AND DISCHARGED SECRETIONS FROM THE INCISION.

  Patient problems: Fluid Discharge

  MAUDE report 18070229 ↗
• MalfunctionJul 22, 2023Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE THREAD WAS BROKEN. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375514 ↗
• MalfunctionJul 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, BOTH NEEDLE AND THREAD WERE FOUND TO BE BROKEN ON THE 36 UNITS. THE PRODUCT WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270410 ↗
• MalfunctionJul 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246357 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE WHILE OPENING THE SUTURE PACKET, BOTH DEVICES WERE BROKEN AT THE SAME TIME. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600061 ↗
• MalfunctionOct 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WAS UNEXPECTED SEPARATION OF THE NEEDLE FROM THE THREAD WHEN THE SUTURE WAS PULLED OUT OF THE PACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627711 ↗
• MalfunctionSep 22, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD BROKE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513298 ↗
• MalfunctionJul 27, 2021Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN OPENED TWO PACKS OF SUTURES, NONE OF THE SUTURES HAD NEEDLE ON IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233405 ↗
• MalfunctionJun 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN CHOLEDOCHOJEJUNOSTOMY, THE NEEDLE AND THREAD WERE FOUND TO CAME OFF WHEN IT WAS TAKEN OUT OF THE PACKET. A NEW PRODUCT WAS TAKEN OUT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073212 ↗
• MalfunctionJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL PROCEDURE, AT THE START OF THE PROCEDURE THE THREAD GOT DISENGAGED FROM THE NEEDLE WHEN THE NURSE APPLIED THE NEEDLE AND PULLED OUT THE THREAD TO THE ORGANS. IT HAPPENED ON 2 SUTURING DEVICE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054032 ↗
• MalfunctionJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL PROCEDURE, AT THE START OF THE PROCEDURE THE THREAD GOT DISENGAGED FROM THE NEEDLE WHEN THE NURSE APPLIED THE NEEDLE AND PULLED OUT THE THREAD TO THE ORGANS. IT HAPPENED ON TWO SUTURING DEVICE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051535 ↗
• MalfunctionApr 5, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614128 ↗
• MalfunctionFeb 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED WHEN THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343519 ↗
• MalfunctionFeb 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE BROKE ON THE REINFORCEMENT. THERE WAS AN UNEXPECTED BREAKING OF THE SUTURE. THE SAME EVENT OCCURRED ON 36 UNITS OF THE DEVICE. NEW BOX OF SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11293367 ↗
• MalfunctionJan 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, THE NEEDLE DETACHED. A DIFFERENT PACKET WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228690 ↗

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: