Maxon CV 8886 6127-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884523002096), received between Jan 18, 2018 and Jan 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Product Quality Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2018Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANT SURGERY, THERE WAS A DIFFERENCE IN THICKNESS OF NEEDLE AND THE SUTURE STRAND. DUE THE ISSUE, THE DUCT RUPTURED - RESULTING IN TISSUE DAMAGE, BLOOD LOSS GREATER THAN 500 CC, THE SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES AND THERE WAS ALSO A EXTENSION OF THE INCISION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Blood Loss; Injury; No Code Available; Tissue Damage

  MAUDE report 7203919 ↗

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: