Maxon 8886 6261-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884523002584), received between Dec 28, 2018 and Oct 5, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SUTURING SECTION, IN AN OPEN PROCEDURE, BOTH THE NEEDLE AND THREAD BROKE. THE DEVICE KEEPS DISEN GAGING FROM THE NEEDLE. TO RESOLVE THE ISSUE THE SURGEON OPENED A NEW BOX OF SUTURES WITH THE SAME SERIAL NUMBER; BUT IT FACED THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577605 ↗
• MalfunctionNov 2, 2020Break; Expiration Date Error; Break; Expiration Date Error

  ACCORDING TO THE REPORTER, DURING GASTRECTOMY, WHEN THE SURGEON WAS TRYING TO DO SUTURING, THE TIP OF THE NEEDLE SUDDENLY BROKE. IT WAS ALSO NOTED THAT THE PRODUCT PAST ITS SHELF LIFE AT THE TIME OF USE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10768617 ↗
• MalfunctionFeb 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY, THE NEEDLE DETACHED FROM THE STRANDS UPON REMOVAL FROM THE PACKAGING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367430 ↗
• MalfunctionJan 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE REPAIRING 3RD DEGREE TEAR IN AN OPEN PROCEDURE, THE THREAD CAME DETACHED FROM THE NEEDLE. SAME THING HAPPENED WHEN IT WAS REPLACED WITH SAME SUTURE FROM SAME BATCH. ANOTHER ONE DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8260510 ↗
• MalfunctionDec 28, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN REMOVING THE DEVICE FROM THE PACKAGE DURING THE ILEOCOLIC CONTINUOUS ANASTOMOSIS AT A CRITICAL TIME OF LAPAROSCOPIC COLORECTAL SURGERY, THE THREAD BROKE. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202400 ↗

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: