Maxon 8886 6057-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884523001914), received between Jul 20, 2017 and May 1, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DERMAL SUTURE, THE THREAD DETACHED FROM THE NEEDLE DURING USE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19223207 ↗
• MalfunctionOct 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN AN ATTEMPT WAS MADE TO REMOVE THE SUTURE FROM THE PACKET USING A NEEDLE HOLDER, THE NEEDLE AND THE THREAD WERE FOUND TO DETACH (CAME OFF) AT THE SWAGE PART. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720142 ↗
• MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE STRAND WHEN TYING THE KNOT. A NEW SUTURE 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 11674987 ↗
• MalfunctionJun 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE NEEDLE AND THREAD WERE FOUND TO BE DETACHED AT THE TIME OF OPENING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185047 ↗
• MalfunctionJun 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE NEEDLE AND THREAD WERE FOUND TO BE DETACHED AT THE TIME OF OPENING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185018 ↗
• MalfunctionJul 22, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, ON ANASTOMOSIS OF THE SMALL INTESTINE, BOTH THE NEEDLE AND THREAD BROKE. ANOTHER SUTURE WAS TAKEN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813305 ↗
• MalfunctionJun 24, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HAND TENDON REPAIR, WHILE SUTURING A TENDON OF THE INDEX FINGER, THE THREAD CAME OUT THE NEEDLE ON THE FIRST STITCH AND BROKE. FOUR THREADS WERE USED, WITH THE SAME RESULT EVERY TIME. THEY USED ANOTHER STRAND TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727311 ↗
• MalfunctionJun 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE YARN OF THE SUTURE DESERTED FROM THE FIRST PASS THROUGH TISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707873 ↗
• MalfunctionJun 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD DISLODGED FROM THE NEEDLE SEVERAL TIMES.

  Patient problems: No Information

  MAUDE report 8678360 ↗
• MalfunctionMay 13, 2019Break; Break

  ACCORDING TO THE REPORTER, BOTH THE NEEDLE AND THREAD BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8604481 ↗
• MalfunctionDec 3, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PANCREATICODUODENECTOMY PROCEDURE WHILE THE DEVICE WAS BEING APPLIED TO THE ANASTOMOSIS, THE NEEDLE BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124086 ↗
• MalfunctionOct 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING BRICKER ANASTOMOSIS, THE THREAD BROKE. NEW SUTURE WAS OPEN TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990628 ↗
• MalfunctionSep 24, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL PROCEDURE, THE DEVICE THREAD BROKE ON THE HALFWAY OF LIGATION. THREE NEW PACKETS IN THE SAME BOX WERE TAKEN OUT, AND THE SAME EVENT OCCURRED. THEY THEN USED ANOTHER DEVICE WITH DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7903176 ↗
• MalfunctionMar 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE DETACHED. THEY USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7308942 ↗
• MalfunctionOct 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A COUPLE OF STITCHES WERE MADE BUT AFTER A COUPLE STITCHES THE NEEDLE CAME OFF OF THE THREAD EASILY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915425 ↗
• MalfunctionSep 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: DURING A TAPP PROCEDURE, THE PACKAGE OF THE FIRST PACKET WAS OPENED, HOWEVER THE NEEDLE AND SUTURE THREAD WAS DISENGAGED. REPLACED BY A NEW PACKET, HOWEVER THE NEEDLE AND SUTURE THREAD WAS DISENGAGED EASILY. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE STATUS OF THE PATIENT: NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872308 ↗
• MalfunctionJul 20, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: DURING TAPP, THE SUTURE DETACHED EASILY FROM THE NEEDLE. THE EVENT OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS ALIVE WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6729078 ↗

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: