Maxon 8886 6237-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10884523002461), received between Jul 17, 2017 and Oct 16, 2025 — classified as 75 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (59 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING INTESTINAL PURSE-STRING SUTURING, AFTER ONE OF THE NEEDLES SUCCESSFULLY PASSED THROUGH THE PURSE-STRING CLAMP, THE NEEDLE BROKE WHEN THE SURGEON GRASPED IT WITH THE NEEDLE HOLDER. TO RESOLVE THE ISSUE, THE SURGEON IMMEDIATELY AND CAREFULLY HANDED THE NEEDLE TIP TO THE INSTRUMENT NURSE AND CAUTIOUSLY USED THE NEEDLE HOLDER TO EXTRACT THE REMAINING PART OF THE NEEDLE FROM THE PURSE-STRING CLAMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308489 ↗
• MalfunctionSep 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER UPON OPENING THE PACKAGE AND USING THE SUTURE, THE THREAD BODY DETACHED FROM THE NEEDLE AND THE THREAD BROKE IN MULTIPLE PLACES. ANOTHER SUTURE WAS USED AS A REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23072736 ↗
• MalfunctionJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A TOTAL LAPAROSCOPIC RADICAL GASTRECTOMY AND LAPAROSCOPIC INTESTINAL ADHESION LYSIS UNDER GENERAL ANESTHESIA. DURING THE OPERATION, BEFORE USING THE 3/0 PURSE STRING SUTURE, THE INSTRUMENT NURSE CHECKED THE INTEGRITY OF THE NEEDLE TIP AND HANDED IT TO THE SURGEON. WHEN RETURNING IT AFTER USE, THE INSTRUMENT NURSE FOUND THAT THE TIPS OF BOTH NEEDLES WERE PARTIALLY MISSING, AND IMMEDIATELY INFORMED THE SURGEON AND THE CIRCULATING NURSE. THE SURGEON PAUSED THE OPERATION, THE SURGEON USED A MAGNET TO EXPLORE THE SURGICAL INCISION, THE INSTRUMENT NURSE SEARCHED THE STERILE AREA, AND THE CIRCULATING NURSE SEARCHED ALL CLEAN AREAS AND CONTAMINATED AREAS IN THE OPERATING ROOM, AND THE THREE PARTIES SEARCHED TOGETHER. FINALLY, THE INSTRUMENT NURSE FOUND A MISSING NEEDLE TIP ON THE NEEDLE HOLDER THAT WAS ABOUT 4MM LONG, AND THE SURGEON FOUND ANOTHER NEEDLE TIP THAT WAS ABOUT 2MM LONG WHEN HE USED A MAGNET TO EXPLORE THE SURGICAL INCISION. THE BROKEN ENDS OF THE TWO SUTURE NEEDLES WERE ALIGNED, AND THE LENGTH IS EQUAL TO THAT OF THE INTACT SUTURE NEEDLES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324610 ↗
• MalfunctionJun 24, 2025Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A TOTAL LAPAROSCOPIC RADICAL GASTRECTOMY AND LAPAROSCOPIC INTESTINAL ADHESION LYSIS UNDER GENERAL ANESTHESIA. DURING THE OPERATION, BEFORE USING THE 3/0 PURSE STRING SUTURE, THE INSTRUMENT NURSE CHECKED THE INTEGRITY OF THE NEEDLE TIP AND HANDED IT TO THE SURGEON. WHEN RETURNING IT AFTER USE, THE INSTRUMENT NURSE FOUND THAT THE TIPS OF BOTH NEEDLES WERE PARTIALLY MISSING, AND IMMEDIATELY INFORMED THE SURGEON AND THE CIRCULATING NURSE. THE SURGEON PAUSED THE OPERATION, THE SURGEON USED A MAGNET TO EXPLORE THE SURGICAL INCISION, THE INSTRUMENT NURSE SEARCHED THE STERILE AREA, AND THE CIRCULATING NURSE SEARCHED ALL CLEAN AREAS AND CONTAMINATED AREAS IN THE OPERATING ROOM, AND THE THREE PARTIES SEARCHED TOGETHER. FINALLY, THE INSTRUMENT NURSE FOUND A MISSING NEEDLE TIP ON THE NEEDLE HOLDER THAT WAS ABOUT 4MM LONG, AND THE SURGEON FOUND ANOTHER NEEDLE TIP THAT WAS ABOUT 2MM LONG WHEN HE USED A MAGNET TO EXPLORE THE SURGICAL INCISION. THE BROKEN ENDS OF THE TWO SUTURE NEEDLES WERE ALIGNED, AND THE LENGTH IS EQUAL TO THAT OF THE INTACT SUTURE NEEDLES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324560 ↗
• MalfunctionJun 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR PURSE-STRING SUTURES BROKE CONTINUOUSLY DURING USE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235489 ↗
• MalfunctionJun 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR PURSE-STRING SUTURES BROKE CONTINUOUSLY DURING USE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235357 ↗
• MalfunctionJun 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR PURSE-STRING SUTURES BROKE CONTINUOUSLY DURING USE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235339 ↗
• MalfunctionJun 17, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FOUR PURSE-STRING SUTURES BROKE CONTINUOUSLY DURING USE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235098 ↗
• MalfunctionMay 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969166 ↗
• MalfunctionJul 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NURSE UNPACKED THE PACKAGE, IT WAS FOUND THAT THE NEEDLE AND SUTURE DETACHED OUTSIDE THE HOLDER/RETAINER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739736 ↗
• MalfunctionJun 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHILE ATTEMPTING TO USE THE DEVICE, THE THREAD DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499854 ↗
• MalfunctionJun 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UTERINE FIBROID ENUCLEATION, DURING USE OF THE DEVICE, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19463912 ↗
• MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND THREAD SEPARATED. THE HAND-WASHING NURSE OPENED THREE SUTURE PACKAGES FROM THE SAME LOT NUMBER AND FOUND THAT THE NEEDLES AND SUTURES WERE DETACHED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797513 ↗
• MalfunctionFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND THREAD SEPARATED. THE HAND-WASHING NURSE OPENED THREE SUTURE PACKAGES FROM THE SAME LOT NUMBER AND FOUND THAT THE NEEDLES AND SUTURES WERE DETACHED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785194 ↗
• MalfunctionDec 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE PACKAGE WAS JUST OPENED BY HAND, BOTH NEEDLE AND THREAD BROKE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18294487 ↗
• MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY PROCEDURE, WHEN PREPARING FOR THE ESOPHAGEAL POUCH SUTURE AND AFTER OPENING THE PACKAGE, THE NEEDLE AND THREAD CONNECTIONS WERE SEPARATED, AND TWO CONSECUTIVE PACKS OF SUTURES WERE THE SAME. ADDITIONAL USE OF THE BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133948 ↗
• MalfunctionNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY PROCEDURE, WHEN PREPARING FOR THE ESOPHAGEAL POUCH SUTURE AND AFTER OPENING THE PACKAGE, THE NEEDLE AND THREAD CONNECTIONS WERE SEPARATED, AND TWO CONSECUTIVE PACKS OF SUTURES WERE THE SAME. ADDITIONAL USE OF THE BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133832 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PACKAGES OF TWO PACKS OF PURSE THREADS WERE OPENED AND THE NEEDLE AND THREAD WERE SEPARATE. ONE OF TWO PACKS THE NEEDLE HAD A BENT NEEDLE. AND THE THREAD OF ANOTHER PACK BROKE WHILE SUTURING THE PURSE USING THE PURSE STITCHING TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125767 ↗
• MalfunctionNov 11, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PACKAGES OF TWO PACKS OF PURSE THREADS WERE OPENED AND THE NEEDLE AND THREAD WERE SEPARATE. ONE OF TWO PACKS THE NEEDLE HAD A BENT NEEDLE. AND THE THREAD OF ANOTHER PACK BROKE WHILE SUTURING THE PURSE USING THE PURSE STITCHING TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116951 ↗
• MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PACKAGES OF TWO PACKS OF PURSE THREADS WERE OPENED AND THE NEEDLE AND THREAD WERE SEPARATE. ONE OF TWO PACKS THE NEEDLE HAD A BENT NEEDLE. AND THE THREAD OF ANOTHER PACK BROKE WHILE SUTURING THE PURSE USING THE PURSE STITCHING TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116908 ↗
• MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGE WAS OPENED, THE THREAD WAS ALREADY FOUND TO BE DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115355 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY DURING UNPACKING, THE THREE NEEDLES WERE SEPARATED FROM THE THREAD. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077721 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY DURING UNPACKING, THE THREE NEEDLES WERE SEPARATED FROM THE THREAD. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077397 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY DURING UNPACKING, THE THREE NEEDLES WERE SEPARATED FROM THE THREAD. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077285 ↗
• MalfunctionOct 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE HANDWASHING NURSE UNPACKED THE SUTURE, IT WAS FOUND THAT THE NEEDLE AND THREAD WERE DETACHED. IT WAS NOTED THAT A NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035933 ↗

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: