Maxon 8886 6403-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523003567), received between Mar 6, 2018 and Jun 3, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE HOLDING CAPACITY OF THE SUTURE USED IN THE LAPAROSCOPIC PROCEDURE WAS 10% LOWER OVER TIME THAN THAT OF A STANDARD THREAD. IN THE PRESENCE OF BACTERIA SUCH AS ESCHERICHIA COLI (E. COLI), DEGRADATION ACCELERATED MANY TIMES OVER. THE SUTURE LACKED AN ANTIBACTERIAL COATING.

  Patient problems: Insufficient Information

  MAUDE report 19448567 ↗
• MalfunctionNov 15, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGERY, THE NEEDLE DISASSEMBLED AT THE TIME OF PASSING THE POINT OF SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9332215 ↗
• MalfunctionMar 6, 2018Bent; Break; Bent; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLEDOCHOLITHOTOMY PROCEDURE, THE NEEDLE BROKE DURING THE CLOSURE OF THE INCISION. A NEW PACKAGE WAS OPENED WITH NEW NEEDLE, BUT THAT NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO ISSUES. THE PATIENT DID NOT SUFFER ANY INJURIES AS A RESULT OF THIS COMPLAINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316647 ↗

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: