Maxon 8886 6632-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521114883), received between Mar 22, 2018 and Feb 12, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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.

• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST PROCEDURE, WHILE SUTURING, THE NEEDLE DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 24320147 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AUGMENTATION MASTOPEXY, DURING SKIN CLOSURE, THE SURGEON USED FOUR SUTURES, AND ON ONE POINT, ALL FOUR NEEDLES DISLODGED FROM THE THREAD. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026730 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AUGMENTATION MASTOPEXY, DURING SKIN CLOSURE, THE SURGEON USED FOUR SUTURES, AND ON ONE POINT, ALL FOUR NEEDLES DISLODGED FROM THE THREAD. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026676 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AUGMENTATION MASTOPEXY, DURING SKIN CLOSURE, THE SURGEON USED FOUR SUTURES, AND ON ONE POINT, ALL FOUR NEEDLES DISLODGED FROM THE THREAD. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026670 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AUGMENTATION MASTOPEXY, DURING SKIN CLOSURE, THE SURGEON USED FOUR SUTURES, AND ON ONE POINT, ALL FOUR NEEDLES DISLODGED FROM THE THREAD. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026445 ↗
• MalfunctionOct 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT REMOVAL AND BREAST LIFT PROCEDURE, THE NEEDLE BROKE OFF FROM THE THREAD. ON THE SECOND DEVICE, THE THREAD BROKE IN THE MIDDLE WHILE THE USER WAS PULLING IT THROUGH THE TISSUE. ADDITIONAL NEW SUTURE OF THE SAME TYPE 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 23367135 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN IMPLANT REMOVAL AND BREAST LIFT PROCEDURE, THE NEEDLE BROKE OFF FROM THE THREAD. ON THE SECOND DEVICE, THE THREAD BROKE IN THE MIDDLE WHILE THE USER WAS PULLING IT THROUGH THE TISSUE. ADDITIONAL NEW SUTURE OF THE SAME TYPE 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 23363702 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY PROCEDURE, THE NEEDLE BROKE OFF FROM THE THREAD. ON THE SECOND DEVICE, THE THREAD BROKE IN THE MIDDLE WHILE THE USER WAS PULLING IT THROUGH THE TISSUE. ADDITIONAL NEW SUTURES WERE 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 23358326 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ABDOMINOPLASTY PROCEDURE, THE NEEDLE BROKE OFF FROM THE THREAD. ON THE SECOND DEVICE, THE THREAD BROKE IN THE MIDDLE WHILE THE USER WAS PULLING IT THROUGH THE TISSUE. ADDITIONAL NEW SUTURES WERE 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 23358053 ↗
• MalfunctionApr 15, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE FROM THE NEEDLE DURING SUTURING.

  Patient problems: Insufficient Information

  MAUDE report 19106286 ↗
• MalfunctionFeb 27, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING, DURING SKIN CLOSURE, WHILE DOING A RUNNING STITCH, THE THREAD BROKE. THERE WERE 2 DEFECTIVE DEVICE INVOLVED. THEY OPENED ANOTHER DEVICE TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8373361 ↗
• MalfunctionApr 18, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE¿S NEEDLE BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7441318 ↗
• MalfunctionMar 22, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE IS FALLING OFF THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7362860 ↗

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: