Maxon 8886 6612-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884523003994), received between May 9, 2018 and Nov 7, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE POPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 20632925 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY,  WHILE SUTURING, THREE TO FOUR SUTURES HAD THE NEEDLE DETACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805569 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY,  WHILE SUTURING, THREE TO FOUR SUTURES HAD THE NEEDLE DETACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805564 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE SUTURING, THREE TO FOUR SUTURES HAD THE NEEDLE DETACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805524 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY,  WHILE SUTURING, THREE TO FOUR SUTURES HAD THE NEEDLE DETACH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805521 ↗
• MalfunctionMar 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, MORE THAN 10 SUTURES BROKE AT THE SWAGE.

  Patient problems: Insufficient Information

  MAUDE report 16523591 ↗
• MalfunctionFeb 15, 2023Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 16379682 ↗
• MalfunctionFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SUTURE STRAND SEPARATED FROM THE NEEDLE AT THE SWAGE MULTIPLE TIMES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291735 ↗
• MalfunctionDec 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THERE WERE MULTIPLE BAD SUTURES FALLING OFF THE NEEDLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16013962 ↗
• MalfunctionSep 9, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BENT AND BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395275 ↗
• MalfunctionApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN EXCISION OF A NAEVUS, AT THE END WHEN SUTURING, THE NEEDLE DETACHED FROM THE THREAD AS A WHOLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736023 ↗
• MalfunctionAug 29, 2019Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE KEPT BREAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8947664 ↗
• MalfunctionMay 9, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAS BEEN OPENED OR REMOVED FROM THE PACKAGING IMMEDIATELY PRIOR TO USE AND THE NEEDLE BROKE DURING SUTURING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500497 ↗

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: