Maxon 8886 6532-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884523003888), received between Mar 25, 2019 and Feb 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.

• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE PREPARING THE THREE DEVICES AFTER PATIENT INCISION, THE THREADS WERE FOUND TO BE MISSING. ONLY ONE THREAD WAS RECOVERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383511 ↗
• MalfunctionNov 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PEDIATRIC SURGICAL OPERATION, DURING DERMAL SUTURING, THE NEEDLE BROKE AT THE CENTER AND SWAGE AREA. IT OCCURRED ON TWO SUTURES. ANOTHER COMPANY'S PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666076 ↗
• MalfunctionNov 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PEDIATRIC SURGICAL OPERATION, DURING DERMAL SUTURING, THE NEEDLE BROKE AT THE CENTER AND SWAGE AREA. IT OCCURRED ON TWO SUTURES. ANOTHER COMPANY'S PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666071 ↗
• MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY HERNIA PROCEDURE, WHEN THE PACKAGE WAS OPENED AND IT WAS TRIED TO TAKE IT OUT, THE NEEDLE AND THREAD WERE DETACHED. A NEW PACKAGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063059 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN THE NURSE TRIED TO PASS THE SUTURE TO THE DOCTOR, THE THREAD AND NEEDLE CAME OFF AT THE SWAGE ON TWO SUTURES. ANOTHER NEW SUTURE WAS USED WITHOUT ISSUE.

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

  MAUDE report 12913611 ↗
• MalfunctionSep 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING SUBCUTANEOUS SUTURING OF CLOSED CHEST, THE DEVICE WAS HELD BY THE NEEDLE HOLDER AND NEEDLE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531182 ↗
• MalfunctionMar 25, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NURSE INFORMED THAT THE THREAD BROKE AND IT WAS UNABLE TO SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8447922 ↗

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: