Maxon 8886614721-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521757707), received between Aug 20, 2020 and Mar 19, 2026 — classified as 5 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 16, 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.

• MalfunctionMar 19, 2026Break

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED PANCREATICODUODENECTOMY (DA VINCI), EVEN THOUGH THE SUTURE IS SUPPOSED TO HAVE HIGH TENSILE STRENGTH, THE SUTURE BROKE ON THE PROXIMAL SIDE RELATIVE TO THE AREA CLAMPED BY THE NEEDLE HOLDER, AND FREQUENT BREAKAGE WAS ALSO OBSERVED AT THE LIGATION POINT DURING THE LIGATION OPERATION. THE ISSUE OCCURRED ON THREE SUTURES FROM THE SAME BOX AND TWO FROM A DIFFERENT KIND OF SUTURES. THE SURGERY WAS COMPLETED USING ANOTHER COMPANY'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637592 ↗
• MalfunctionMar 19, 2026Break

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED PANCREATICODUODENECTOMY (DA VINCI), EVEN THOUGH THE SUTURE IS SUPPOSED TO HAVE HIGH TENSILE STRENGTH, THE SUTURE BROKE ON THE PROXIMAL SIDE RELATIVE TO THE AREA CLAMPED BY THE NEEDLE HOLDER, AND FREQUENT BREAKAGE WAS ALSO OBSERVED AT THE LIGATION POINT DURING THE LIGATION OPERATION. THE ISSUE OCCURRED ON THREE SUTURES FROM THE SAME BOX AND TWO FROM A DIFFERENT KIND OF SUTURES. THE SURGERY WAS COMPLETED USING ANOTHER COMPANY'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637591 ↗
• MalfunctionMar 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE THE DEVICE WAS STILL IN THE PACKAGING, THE SURGEON NOTICE THAT THE NEEDLE WAS NOT ATTACHED TO THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658894 ↗
• MalfunctionNov 30, 2021Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN TOTAL CYSTECTOMY SURGERY, WHEN TIGHTENING AND CLOSING THE WOUND, THE THREAD BROKE. THE DEFECTIVE THREAD WAS THEN REMOVED AND A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895782 ↗
• MalfunctionAug 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN TRYING TO TAKE THE PRODUCT OUT OF THE PACKAGE DURING A PROXIMAL PANCREATICODUODENECTOMY, THE NEEDLE CAME OFF WHEN GRASPED WITH A NEEDLE HOLDER. THE PRODUCT WAS NOT USED FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435140 ↗

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: