Maxon 8886 6213-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884523002317), received between Nov 13, 2017 and Mar 20, 2025 — classified as 2 injuries, 6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE PREPARING BEFORE PATIENT USE, WHEN THE SUTURE WAS BEING PULLED OUT FROM THE RETAINER, THE NEEDLE DETACHED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655036 ↗
• MalfunctionOct 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, RESECTION OF MUCUS CYST, AT THE TIME OF SEWING THE LIPS TOGETHER WHILE DOING A CONTINUOUS SUTURING TECHNIQUE, AFTER OPENING THE PACKAGE, THE NEEDLE AND THREAD SEPARATED FROM THE THREADING AREA. A NEW SUTURE FROM THE SAME BATCH WAS USED WITHOUT ANY PROBLEM. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15654758 ↗
• MalfunctionSep 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE'S NEEDLE DETACHED WHEN THE SUTURE WAS REMOVED FROM THE MOUNT. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485000 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE OPERATION FOR DUODENAL ATRESIA OPEN PROCEDURE, THE PATIENT UNDERWENT SECOND OPERATION AND ANASTOMOTIC LEAK WAS FOUND. ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE. THE PATIENT HAD DISTENDED ABDOMEN AND FEVER POST OPERATION. THE X-RAY SHOWED FREE AIR.

  Patient problems: Bowel Perforation; Fever; No Code Available; Radiation Exposure, Unintended

  MAUDE report 9889046 ↗
• InjuryMar 16, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE FROM A TRANSANAL PULL THROUGH, PATIENT REVISITED BECAUSE HIS FECES HAD SUTURES IN IT. A SECOND OPERATION WAS PERFORMED AND FOUND THAT ALMOST ALL SUTURES DISLODGED FROM THE ANASTOMOTIC POINT. LAPAROTOMY WAS DONE AND ANASTOMOTIC LEAK WAS FOUNDED. RESUTURING WAS PERFORMED.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 9834934 ↗
• MalfunctionOct 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN WHIPPLE PROCEDURE, THE NEEDLE BROKE OFF FROM THE THREAD ON A COUPLE OF SUTURES WITH THE SAME LOT NUMBER. ANOTHER SUTURE WAS USED FROM THE SAME LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203532 ↗
• MalfunctionJun 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, WHEN THE PRODUCT WAS OPENED, THE THREAD WAS DISENGAGED FROM THE NEEDLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8693327 ↗
• MalfunctionNov 13, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON THE FIRST STITCH, THE NEEDLE CAME OFF THE THREAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7024854 ↗

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: