Maxon CV 8886 6145-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884523002171), received between Apr 9, 2020 and Feb 15, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE UROLOGICAL SURGERY, A FEW MINUTES AFTER THE DEVICE HAD BEEN OPENED, THE NEEDLE BROKE. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716611 ↗
• MalfunctionMay 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING PYELOGENESIS, NEEDLES FROM ONE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16914991 ↗
• MalfunctionJun 17, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PELVIC ADHESION RELEASE, WHILE PERFORMING TUBAL ANASTOMOSIS, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED DUE TO THE ISSUE.

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

  MAUDE report 12016476 ↗
• MalfunctionApr 9, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A MAJOR DEBRIDEMENT SURGERY OF AN OPEN TOE INJURY, WHEN THE DOCTOR CLEANED UP AND PREPARED FOR SUTURING, THE FIRST NEEDLE BROKE. IT WAS PARTIALLY CUT OFF AND HALF OF THE NEEDLE WAS STUCK IN THE TISSUE. THE DOCTOR CALLED THE NURSE TO FIND THE NEEDLE AND PUT IT TOGETHER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9947470 ↗
• MalfunctionApr 9, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE FINISHING DEBRIDEMENT OF THE PATIENT'S TOE, THE DOCTOR USED NEEDLE HOLDING FORCEPS TO CLAMP THE NEEDLE AND SUTURE THE SKIN. DURING THE FIRST NEEDLE SUTURE, THE NEEDLE BROKE AND HALF OF IT WAS STUCK IN THE TISSUE. THEN THE DOCTOR TOOK OUT THE BROKEN NEEDLE WITH A NEEDLE HOLDING FORCEPS AND SPLICED IT TOGETHER. THE SUTURE NEEDLE AND THREAD WERE REPLACED TO CONTINUE STITCHING THE SKIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9947465 ↗

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: