Maxon 8886 6245-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884523001808), received between Jul 13, 2021 and Mar 10, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE, DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555959 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN INGUINAL HERNIA REPAIR, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369233 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED FROM THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367244 ↗
• MalfunctionJan 30, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226948 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OFF THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821372 ↗
• MalfunctionAug 10, 2021Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE SURGEON WAS UNABLE TO TIE KNOTS. THE SUTURE WOULD BREAK BEFORE THE KNOT WAS COMPLETED. THE SURGEON TRIED DIFFERENT METHODS OF TYING AND DIFFERENT NEEDLE DRIVERS BUT THE SUTURE WAS STILL DISINTEGRATING.

  Patient problems: Insufficient Information

  MAUDE report 12302330 ↗
• MalfunctionJul 13, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHEN SUTURING A BIOLOGIC MESH, THE 3 THREADS BROKE APART WHEN PULLING THE KNOTS. ANOTHER TYPE OF STRAND WAS USED TO RESUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160752 ↗

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: