Maxon CV 8886 6147-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523002195), received between Nov 7, 2018 and Jul 21, 2020 — classified as 3 malfunctions.

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

• MalfunctionJul 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED ON PROXIMAL PANCREATICODUODENECTOMY, THE NEEDLE CAME OFF DURING THE SUTURING. IT WAS ALSO NOTED THAT NOTHING FELL INTO THE PATIENT'S CAVITY. ANOTHER NEEDLE WAS TAKEN OUT TO DEAL WITH THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302386 ↗
• MalfunctionMay 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY, THE NEEDLE AND THREAD CAME OFF WHEN THE SCRUB NURSE TOOK THE DEVICE OUT OF THE PACKET OR WHEN PULLING ACTION WAS PERFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053253 ↗
• MalfunctionNov 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE HAD DISENGAGED FROM THE THREAD RIGHT AFTER OPENING THE PACKET AND COULD NOT BE USED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8046215 ↗

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: