Maxon 8886 6245-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523002485), received between Oct 14, 2020 and Dec 20, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionDec 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. NO INJURY OR CONSEQUENCES TO THE PATIENT WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858399 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT DURING ANTERIOR COLPORRHAPHY AND LAPAROSCOPIC ADNEXECTOMY ON BOTH SIDES. WHILE SUTURING, THE NEEDLE POINT WAS BROKEN AND THE THREAD WAS ALSO BROKEN. THE SURGEON USED A NEW SUTURE FROM THE SAME LOT. THERE WAS NO IMPACT OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21062485 ↗
• MalfunctionMay 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC SURGERY, WHILE SUTURING, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498399 ↗
• MalfunctionOct 14, 2020Product Quality Problem; Use of Device Problem; Product Quality Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SUTURES WERE DIFFICULT TO HANDLE. SUTURE ARE LESS FLUID AND THE LONG-TERM TENSION RETENTION IS LOWER THAN WHAT WAS USED BEFORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10678443 ↗

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: