Maxon CV 8886 6149-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523002225), received between Sep 5, 2018 and Aug 25, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HEPATECTOMY PROCEDURE, WHEN THE PRODUCT WAS OPENED, THE NEEDLE ON ONE SIDE OF THE DOUBLE-ARMED SUTURE WAS FOUND TO BE DISCONNECTED FROM THE THREAD. THE PRODUCT WAS NOT USED TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10452123 ↗
• MalfunctionAug 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN WHIPPLE PROCEDURE, WHILE PERFORMING PANCREATIC ANASTOMOSIS AND EMPLOYING A CONTINUOUS STITCHING TECHNIQUE, ONE NEEDLE DISCONNECTED FROM THE SUTURE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362349 ↗
• MalfunctionApr 3, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE THREAD BROKE, AND WHILE ATTEMPTING TO LOAD THE NEEDLE DRIVE THE TECH NOTICED THE NEEDLE WAS NO LONGER WITH THE DRIVER. THE NEEDLE WAS LOCATED ON THE OTHER SIDE OF THE PATIENT ON THE FLOOR OPPOSITE SIDE OF THE TECH. THE THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479345 ↗
• InjurySep 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY, WHILE THE DEVICE WAS USED FOR ANASTOMOSIS OF BILIARY DUCT AND ANASTOMOSIS OF JEJUNUM, THE DEVICE NEEDLE WAS DETACHED FROM THE THREAD, TO RESOLVE THE ISSUE THE SURGEON REPEATED THE ANASTOMOSES AND USED ANOTHER DEVICE TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES AND THERE WAS A TISSUE DAMAGE DUE TO THE DEVICE PROBLEM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7846824 ↗

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: