Maxon 8886 6285-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523002775), received between Jan 22, 2025 and Jan 22, 2025 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, FIVE NEEDLE TIPS BROKE. THE NEEDLE TIP FELL AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21208617 ↗
• MalfunctionJan 22, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, FIVE NEEDLE TIPS BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21208608 ↗
• MalfunctionJan 22, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, FIVE NEEDLE TIPS BROKE. THE NEEDLE TIP FELL AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21208461 ↗
• MalfunctionJan 22, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, FIVE NEEDLE TIPS BROKE. THE NEEDLE TIP FELL AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21208454 ↗

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: