Maxon 8886 6269-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884523002706), received between Jun 28, 2018 and Sep 10, 2025 — classified as 4 injuries, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Dull, Blunt; Detachment of Device or Device Component; Dull, Blunt; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN COLON RESECTION, THE TWO NEEDLES WERE VERY DULL OUT OF THE PACKAGE AND BECAME DULL QUICKLY DURING USE. SUBSEQUENTLY WHILE SUTURING, NEEDLE DETACHMENT OCCURRED. THE NEEDLES DID NOT FALL INTO THE PATIENT CAVITY, AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015374 ↗
• InjuryJul 28, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE PATIENT WHO UNDERWENT LAPAROSCOPIC ENTERORRHAPHY ON (B)(6) 2025, WAS READMITTED TO THE HOSPITAL ON (B)(6) 2025. THE INITIAL SURGERY INCLUDED MIDLINE CLOSURE WITH TWO STRANDS OF POLYGLUCONATE O USING THE MALL-BITES TECHNIQUE. UPON READMISSION TO THE WARDS ON (B)(6) 2025, A MIDLINE OPENING IN THE ABDOMINAL WALL WAS FOUND, WHICH WAS DEHISCED. ADDITIONAL SURGERY WAS PERFORMED TO RESOLVE THE ISSUE. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED.

  Patient problems: Failure to Anastomose; Insufficient Information

  MAUDE report 22638337 ↗
• InjuryJul 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A RIGHT HEMICOLECTOMY WITH SEGMENTAL SMALL BOWEL RESECTION AND ILEOTRANSVERSE ANASTOMOSIS ON (B)(6) 2025, THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2025 DUE TO SURGICAL WOUND DEHISCENCE THAT HAD DEVELOPED ONE DAY EARLIER. THERE WAS ALSO DEHYDRATION OF THE SUTURE THREAD.

  Patient problems: Wound Dehiscence

  MAUDE report 22578178 ↗
• 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. AFTER THE USER WASHED AND CLOSED THE WOUND, IT WAS LEFT OPEN TO PREVENT INFECTION. NO STEROIDS HAVE BEEN GIVEN TO THE PATIENT AND 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 WAS DEBRIDED. IT WAS NOTED THERE WILL BE AN ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE. IT WAS NOTED THAT THE PATIENT WAS CRITICALLY ILL WITH CHRONIC PERITONITIS.

  Patient problems: Hernia; Necrosis; Peritonitis; Unspecified Tissue Injury

  MAUDE report 15641490 ↗
• InjuryJan 12, 2021Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, ONE MONTH POST-OPERATIVELY, WHEN THE SUTURE SHOULD HAVE NOT YET BEEN ABSORBED, THE HERNIA WAS NOTICED. IT WAS ALSO REPORTED THAT THE DEVICE KNOT WAS INTACT BUT THE SUTURE WAS BROKEN AND IT DID NOT HOLD. THE PATIENT IS SCHEDULED TO HAVE AN INCISIONAL HERNIA REPAIR TO RESOLVE THE ISSUE.

  Patient problems: Hernia

  MAUDE report 11154526 ↗
• MalfunctionJun 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SUTURE WAS OPENED AND THE NEEDLE WAS NOT ATTACHED. ANOTHER INSTRUMENT WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648992 ↗

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: