Maxon 8886620721-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521757776), received between Apr 22, 2022 and Apr 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EXCISION OF SKIN LESION ON THE FACE, AFTER THE SUTURE WAS LOADED INTO A NEEDLE HOLDER AND FOLLOWING ONE PASS THROUGH SKIN, THE NEEDLE CAME AWAY FROM THE SUTURE MATERIAL. A REPLACEMENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020612 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EXCISION OF SKIN LESION ON THE FACE, AFTER THE SUTURE WAS LOADED INTO A NEEDLE HOLDER AND FOLLOWING ONE PASS THROUGH SKIN, THE NEEDLE CAME AWAY FROM THE SUTURE MATERIAL. A REPLACEMENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020594 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EXCISION OF SKIN LESION ON THE FACE, AFTER THE SUTURE WAS LOADED INTO A NEEDLE HOLDER AND FOLLOWING ONE PASS THROUGH SKIN, THE NEEDLE CAME AWAY FROM THE SUTURE MATERIAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020537 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EXCISION OF SKIN LESION ON THE FACE, AFTER THE SUTURE WAS LOADED INTO A NEEDLE HOLDER AND FOLLOWING ONE PASS THROUGH SKIN, THE NEEDLE CAME AWAY FROM THE SUTURE MATERIAL. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020339 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EXCISION OF SKIN LESION ON THE FACE, AFTER THE SUTURE WAS LOADED INTO A NEEDLE HOLDER AND FOLLOWING ONE PASS THROUGH SKIN, THE NEEDLE CAME AWAY FROM THE SUTURE MATERIAL. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. IT WAS REPORTED THAT THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020330 ↗
• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN EXCISION OF SKIN LESION ON THE FACE, AFTER THE SUTURE WAS LOADED INTO A NEEDLE HOLDER AND FOLLOWING ONE PASS THROUGH SKIN, THE NEEDLE CAME AWAY FROM THE SUTURE MATERIAL. A REPLACEMENT SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020219 ↗
• MalfunctionFeb 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN WITHDRAWING THE DEVICE FROM THE RETAINER AND PREPARING FOR USE, THE NEEDLE AND THREAD DETACHED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326668 ↗
• MalfunctionMar 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A WHIPPLE PROCEDURE, AND WHILE THE SURGEON WAS DOING ANASTOMOSIS, THE THREE STRANDS BROKE TWO INCHES FROM THE NEEDLE. IT OCCURRED WITH MINIMAL PULL ON THE STRAND. REPLACED BROKEN SUTURE WITH OTHERS OF THE SAME LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842240 ↗
• MalfunctionMar 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A WHIPPLE PROCEDURE, AND WHILE THE SURGEON WAS DOING ANASTOMOSIS, THE THREE STRANDS BROKE TWO INCHES FROM THE NEEDLE. IT OCCURRED WITH MINIMAL PULL ON THE STRAND. REPLACED BROKEN SUTURE WITH OTHERS OF THE SAME LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842234 ↗
• MalfunctionMar 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A WHIPPLE PROCEDURE, AND WHILE THE SURGEON WAS DOING ANASTOMOSIS, THE THREE STRANDS BROKE TWO INCHES FROM THE NEEDLE. IT OCCURRED WITH MINIMAL PULL ON THE STRAND. REPLACED BROKEN SUTURE WITH OTHERS OF THE SAME LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842210 ↗
• MalfunctionJul 18, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PANCREATIC-ANASTOMOSIS PROCEDURE, WHEN STARTING SEWING VIA CONTINUOUS SUTURE TECHNIQUE BY ANASTOMOSIS, THREE THREADS THAT THE NEEDLE CAME OFF AND ON TWO THREADS, THE SUTURE BROKE IN THE MIDDLE. IT WAS NOTED THAT NO COMPONENT FELL INTO PATIENT'S CAVITY. TO RESOLVE THE ISSUE, IT WAS STARTED AGAIN WITH A NEW SUTURE FROM THE SAME SERIES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344327 ↗
• MalfunctionJul 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PANCREATIC-ANASTOMOSIS PROCEDURE, WHEN STARTING SEWING VIA CONTINUOUS SUTURE TECHNIQUE BY ANASTOMOSIS, THREE THREADS THAT THE NEEDLE CAME OFF AND ON TWO THREADS, THE SUTURE BROKE IN THE MIDDLE. IT WAS NOTED THAT NO COMPONENT FELL INTO PATIENT'S CAVITY. TO RESOLVE THE ISSUE, IT WAS STARTED AGAIN WITH A NEW SUTURE FROM THE SAME SERIES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319613 ↗
• MalfunctionApr 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SUTURE WAS OPENED, NEEDLE HOLDER WAS PUT ON NEEDLE AND IT POPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 14188184 ↗

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: