Maxon CV 8886 6134-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523002133), received between Feb 6, 2018 and Nov 3, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY PROCEDURE DURING ANASTOMOSIS, PRIOR TO PATIENT USE, THE NEEDLE WAS FOUND DETACHED FROM T HE SUTURE AND THE SUTURE WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 23459177 ↗
• MalfunctionApr 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC WHIPPLE, AT THE TIME OF ANASTOMOSIS, THE THREAD BROKE. ANOTHER SUTURE FROM DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716862 ↗
• MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GENERAL DIGESTIVE SURGERY, THE NEEDLE SEPARATED FROM THE WIRE WHILE THE NURSE WAS SUTURING THE PATIENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 11920990 ↗
• MalfunctionFeb 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, DUODENAL REPAIR AND HEPATICOJEJUNOSTOMY, WHILE BEING APPLIED AT THE ANASTOMOSIS, BOTH THE NEEDLE AND THE THREAD BROKE HALFWAY INTO THE PROCEDURE. THE ADDITIONAL SUTURE FROM THE SAME BOX WAS USED WITH SAME ISSUE. RESULTING IN OPENING ANOTHER NEW BOX WITH DIFFERENT BATCH NO. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7245092 ↗

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: