Maxon 8886 6201-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523001778), received between Aug 2, 2018 and Aug 14, 2024 — classified as 1 injury, 2 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 16, 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.

• InjuryAug 14, 2024Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION PROCEDURE, WHEN THE DEVICE WAS USED FOR SUBCUTANEOUS WOUND OR SURGICAL INCISION CLOSURE, THE SURGEON TRIED TO PULL OUT THE REMOVABLE NEEDLE, BUT THE SWAGE WAS CLAMPED TOO MUCH WITH THE NEEDLE HOLDER. EXCESSIVE FORCE WAS APPLIED TO PULL OUT THE NEEDLE; HOWEVER, THE NEEDLE BROKE AT THE SWAGE AND WAS LOST. A COMPUTER TOMOGRAPHY (CT) SCAN REVEALED THAT THE NEEDLE REMAINED IN THE PATIENT¿S BODY. ADDITIONAL SURGERY WILL BE PERFORMED TO REMOVE THE NEEDLE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19981512 ↗
• MalfunctionMar 30, 2021Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS OPENED PRIOR TO USE, A KNOT WAS FOUND TO BE ORIGINALLY MADE. AFTER THAT, A NEW PRODUCT WAS OPENED FOR USING, BUT THE THREAD BROKE SOON AFTERWARDS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590961 ↗
• MalfunctionAug 2, 2018Break

  ACCORDING TO THE REPORTER DURING A PROXIMAL PANCREATICODUODENECTOMY THE 4 SUTURES BROKE REPEATEDLY. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742194 ↗

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: