Maxon CV 8886 6139-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523002157), received between Dec 12, 2019 and Jun 21, 2021 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A HYPOSPADIAS FORMATION SURGERY, WHEN AN ATTEMPT WAS MADE TO TIE A LIGATION DURING URETHRAL FORMATION, 3 SUTURE OF THE SAME LOT BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037612 ↗
• InjuryNov 5, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE SUTURING DURING AN OPEN ABDOMINAL SURGERY, THE NEEDLE WAS BROKEN. THE SURGEON HAD TO PERFORM X-RAY. THIS RESULTED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES.

  Patient problems: Foreign Body In Patient; No Code Available; Unintended Radiation Exposure

  MAUDE report 10795548 ↗
• MalfunctionDec 12, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A UROLOGY PROCEDURE, NEEDLE BREAKAGE OCCURRED. THE PART THAT FELL INTO THE PATIENT CAVITY WAS RETRIEVED. THEY TOOK TIME TO REMOVE THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH MANUAL SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9457613 ↗

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: