Maxon 8886 6608-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884523003949), received between Jul 24, 2018 and Apr 6, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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.

• MalfunctionApr 6, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EXCISION OF A SKIN CANCER, THE NEEDLE DETACHED FROM THE SUTURE THREAD WHEN IT WAS REMOVED FROM THE PACKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794405 ↗
• MalfunctionApr 6, 2026Break

  ACCORDING TO THE REPORTER, DURING A MOHS MICROGRAPHIC SURGERY, TWO SUTURES NEEDLE NOT ATTACHED TO THE LINE PRIOR TO PATIENT USE AND ANOTHER TWO SUTURES BROKE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794358 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A MOHS MICROGRAPHIC SURGERY, TWO SUTURES NEEDLE NOT ATTACHED TO THE LINE PRIOR TO PATIENT USE AND ANOTHER TWO SUTURES BROKE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794281 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A MOHS MICROGRAPHIC SURGERY, TWO SUTURES NEEDLE NOT ATTACHED TO THE LINE PRIOR TO PATIENT USE AND ANOTHER TWO SUTURES BROKE WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794268 ↗
• MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A MOHS CLOSURE, SUTURE WAS NOT CONNECTED TO THE NEEDLE. THE SUTURE WAS CUT, REMOVED, AND ANOTHER SUTURE PACK WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21762430 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, UPON OPENING, THE THREAD WAS DETACHED FROM THE NEEDLE WHILE IN THE RETAINER OR HOLDER. ANOTHER SUTURE FROM THE SAME BOX WAS GIVEN AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380567 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, UPON OPENING, THE THREAD WAS DETACHED FROM THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378203 ↗
• MalfunctionFeb 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HEMITHYROIDECTOMY, THE SUTURE BROKE BETWEEN THE NEEDLE AND THE THREAD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343426 ↗
• MalfunctionJun 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVE TO A DENTAL PROCEDURE, WHEN TAKING SUTURE MATERIAL OUT OF THE PACK, THREE SUTURES DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10208948 ↗
• MalfunctionMay 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VARIZEN BDS PROCEDURE, WHEN THE NURSE WAS PREPARING THE SUTURE FOR THE SURGEON, THE NEEDLE AND THREAD SEPARATED IN THE PACKAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080000 ↗
• MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8225030 ↗
• MalfunctionJan 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE SUTURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8224940 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THERE WAS A FAULTY SUTURE WITH DETACHED NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7713736 ↗

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: