Maxon CV 8886 6127-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523002089), received between Apr 6, 2021 and Feb 2, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PEDIATRIC PROCEDURE, AT THE FINAL STAGE, VIA CONTINUOUS SUTURING TECHNIQUE, MORE THAN ONE ABSORBABLE SUTURE WAS USED, AND THE STITCHES BROKE REPEATEDLY. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE SUTURE WAS CHANGED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18633672 ↗
• MalfunctionFeb 2, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PEDIATRIC PROCEDURE, AT THE FINAL STAGE, VIA CONTINUOUS SUTURING TECHNIQUE, MORE THAN ONE ABSORBABLE SUTURE WAS USED, AND THE STITCHES BROKE REPEATEDLY. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE SUTURE WAS CHANGED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632310 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR PROCEDURE, THE SUTURE BROKE. ANOTHER PACKAGE WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE ISSUE OCCURRED ON ALL 7 SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460536 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR PROCEDURE, THE SUTURE BROKE. ANOTHER PACKAGE WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE ISSUE OCCURRED ON ALL 7 SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459341 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR PROCEDURE, THE SUTURE BROKE. ANOTHER PACKAGE WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE ISSUE OCCURRED ON ALL 7 SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459305 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR PROCEDURE, THE SUTURE BROKE. ANOTHER PACKAGE WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE ISSUE OCCURRED ON ALL 7 SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459138 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR PROCEDURE, THE SUTURE BROKE. ANOTHER PACKAGE WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE ISSUE OCCURRED ON ALL 7 SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459066 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR PROCEDURE, THE SUTURE BROKE. ANOTHER PACKAGE WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE ISSUE OCCURRED ON ALL 7 SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459033 ↗
• MalfunctionJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS REPAIR PROCEDURE, THE SUTURE BROKE. ANOTHER PACKAGE WAS OPENED BUT THE SAME PROBLEM OCCURRED. THE ISSUE OCCURRED ON ALL 7 SUTURES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18459024 ↗
• MalfunctionApr 6, 2021Break; Break

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING USED ON THE ARTERY OR TENDON DURING AN OPEN HAND PROCEDURE, THE NEEDLE BROKE. A SECOND SUTURE WAS TAKEN AND CHANGED THE NEEDLE HOLDER BUT THE NEEDLE BROKE APART AGAIN. ANOTHER COMPETITOR'S SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622868 ↗

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: