Maxon 8886 6269-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884523002713), received between Dec 3, 2018 and Aug 26, 2025 — classified as 2 injuries, 3 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 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.

• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE EXPERIENCED NEEDLE DETACHMENT. NO COMPONENT FELL INTO THE PATIENT'S CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900674 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VASCULAR OPEN PROCEDURE, THE NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS ABLE TO FIND EASILY. A NEW SUTURE WAS USED WITH A DIFFERENT LOT NUMBER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238266 ↗
• InjuryOct 20, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON AN OPEN EXPLORATORY LAPAROTOMY, WHILE ON FASCIAL CLOSING, THE RESIDENT CLOSED THE STITCHES IN A STANDARD CONTINUOUS FASHION AND THE KNOTS WERE TIED BY THE SURGEON AT THE END. THE SUTURES WERE BINDING ON ITSELF AND FELT STICKIER THAN USUAL. IT WAS NOTED THAT THE PATIENT WAS STILL ADMITTED. THERE WAS AN UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE. THERE WAS DEAD FASCIA WHICH LEFT THE PATIENT WITH A VENTRAL HERNIA, THAT WHEN HEALTHY ENOUGH, WILL HAVE TO BE DEBRIDED AND REPAIRED WITH MESH. IT WAS NOTED THAT THERE WILL BE AN ADDITIONAL OPERATION TO PERFORM TO CORRECT THE ISSUE.

  Patient problems: Hernia; Necrosis; Unspecified Tissue Injury

  MAUDE report 15641101 ↗
• InjuryOct 20, 2022Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE, USED FOR CLOSING THE FASCIA, THE THREAD BROKE AFTER AT THE POINT THE TISSUE STARTED DYING. THE PATIENT WAS ILL WITH CHRONIC PERITONITIS. AFTER THEY WASH AND CLOSE THE WOUND THEY LEAVE IT OPEN TO PREVENT INFECTION. NO STEROIDS HAVE BEEN GIVEN TO THE PATIENT.

  Patient problems: Hernia; Peritonitis; Unspecified Tissue Injury

  MAUDE report 15640362 ↗
• MalfunctionDec 3, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A OPEN PROCEDURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT CAVITY, THE NEEDLE WAS EVENTUALLY RETRIEVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125357 ↗

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: