Maxon 8886 6267-71Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20884523002673), received between Aug 9, 2017 and Sep 10, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 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 23015317 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BOWEL RESECTION, CLOSING FASCIA, THE SUTURE POPPED OFF THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283666 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BOWEL RESECTION, THE SUTURE POPPED OFF THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186350 ↗
• MalfunctionMar 18, 2025Break; Break

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, WHILE SUTURING, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633659 ↗
• MalfunctionMar 12, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580640 ↗
• MalfunctionMar 11, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576940 ↗
• MalfunctionFeb 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING OR PREPARING THE SUTURE AFTER A PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE WHILE USING. IT WAS NOTED THAT ONE OF TWO PACKAGES CONTAINED A NEEDLE THAT DETACHED EASILY. THE ISSUE OCCURRED DURING THE SAME EVENT WITH THE SAME PATIENT. T O ADDRESS THE ISSUE, ADDITIONAL PACKAGES WERE OPENED. THERE WERE NO REPORTED CONSEQUENCES OR IMPACTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369436 ↗
• MalfunctionDec 30, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN COLECTOMY SURGERY, AT THE TIME OF ABDOMINAL CLOSURE, THE CENTER PART OF THE SUTURE WAS DAMAGED. IT WAS NOTED THAT NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036752 ↗
• MalfunctionSep 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A COLECTOMY, ON ABDOMINAL CLOSING, THERE WAS TENSION OF THE THREE SEWING THREADS CAUSED IT TO BREAK. A SIMILAR PRODUCT FROM ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196070 ↗
• MalfunctionSep 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A COLECTOMY, ON ABDOMINAL CLOSING, THERE WAS TENSION OF THE THREE SEWING THREADS CAUSED IT TO BREAK. A SIMILAR PRODUCT FROM ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195822 ↗
• MalfunctionSep 11, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A COLECTOMY, ON ABDOMINAL CLOSING, THERE WAS TENSION OF THE THREE SEWING THREADS CAUSED IT TO BREAK. A SIMILAR PRODUCT FROM ANOTHER BOX WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195664 ↗
• MalfunctionNov 4, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 3 DAYS AFTER THE POST-OPERATION OF AN OPEN ABDOMEN VETERINARY PROCEDURE, EMERGENCY SURGERY WAS REQUIRED. THE SUTURE DID NOT BREAK DURING USE, BUT POST OPERATIVELY IN THE PATIENT. THE MUSCULAR AND FASCIA OF THE ABDOMINAL WALL WAS CLOSED. HOWEVER, THE ABDOMINAL WALL SUTURE MATERIAL HAD TORN IN THE MIDDLE OF THE WOUND AREA AND THE ABDOMINAL ORGANS WERE HANGING OUT. THE PATIENT HAD PERITONITIS AS A RESULT AND THE PATIENT HOSPITALIZATION WAS EXTENDED.

  Patient problems: Peritonitis; Wound Dehiscence

  MAUDE report 15728059 ↗
• MalfunctionNov 3, 2022Break; Break

  ACCORDING TO THE REPORTER, 5 DAYS AFTER THE POST-OPERATION OF AN OPEN ABDOMEN VETERINARY PROCEDURE, EMERGENCY SURGERY WAS REQUIRED. THE SUTURE DID NOT BREAK DURING USE, BUT POST OPERATIVELY IN THE PATIENT. THE THREAD HAD BROKEN DIRECTLY AT THE KNOT OF A CONTINUOUS SUTURE AND THE ABDOMINAL ORGANS WERE HANGING OUT. IT WAS SCRATCHED ALL UP; A BIT OFF PARTS OF THE BLOOD VESSELS ALMOST DIED WHICH IS LIFE THREATENING. THE PATIENT HAD PERITONITIS AS A RESULT AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED.

  Patient problems: Peritonitis; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 15721840 ↗
• InjuryDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER AN OPEN STERNOTOMY, SURGERY HAD BEEN DONE AGAIN TO CLOSE THE STERNUM AND EXPLANT THE SUTURE THAT FELL INTO THE PATIENT'S CAVITY.

  Patient problems: No Code Available

  MAUDE report 9454638 ↗
• MalfunctionMar 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: THE NEEDLE IS TORN OFF THE THREAD. PENDING TRANSLATION. PATIENT STATUS : UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316205 ↗
• MalfunctionOct 13, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THE PATIENT, A DOG, UNDERWENT AN OPEN CASTRATION PROCEDURE. THE SUTURE WAS BEING USED FOR THE CLOSURE OF THE ABDOMEN AND LINEA ALBA AFTER MIDLINE LAPAROTOMY USING THE CONTINUOUS SUTURE TECHNIQUE. POST OPERATIVELY, BETWEEN TWO TO TEN DAYS, THE SUTURES FOR THE FASCIA BROKE AND LEAD TO SEVERE DEHISCENCE WITH AN OPEN ABDOMEN. AN EMERGENCY REOPERATION WAS REQUIRED WITH ABDOMINAL WASH AND RE-CLOSURE OF THE ABDOMINAL WALL, WHICH RESULTED IN TEMPORARY INJURY. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. THE PATIENT OUTCOME IS ALIVE, WITH INJURY.

  Patient problems: Injury; No Code Available; Tissue Damage; Wound Dehiscence

  MAUDE report 6947730 ↗
• MalfunctionAug 9, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT GOT MARKED REACTIONS AND WOUND INFECTIONS AFTER APPLICATION OF THE SUTURE.

  Patient problems: Unspecified Infection

  MAUDE report 6780261 ↗

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: