Maxon 8886 6277-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523002751), received between Aug 8, 2018 and Apr 14, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, TWENTY DAYS AFTER AN OPEN ROUTINE OVARIOHYSTERECTOMY VETERINARY PROCEDURE, WHERE THE DEVICE WAS USED FOR LIGATURES IN THE ABDOMEN, THERE WAS A SEVERE SUTURE REACTION. THE UTERINE STUMP WAS NECROTIC FROM THE BLADDER. ADDITIONAL SURGERIES WERE PERFORMED TO REMOVE THE NECROTIC PART; THE RIGHT URETER WAS ALSO DISSECTED. A TERTIARY PROCEDURE WAS REQUIRED TO REATTACH THE URETER AND FURTHER REDUCE NECROTIC UTERINE AND, LEFT OVARIAN STUMPS. THIS RESULTED IN AN EXTENDED HOSPITAL STAY AND A SPECIALIST REFERRAL CENTER.

  Patient problems: Necrosis; Unspecified Tissue Injury

  MAUDE report 16744951 ↗
• MalfunctionFeb 17, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FORTY DAYS AFTER AN OPEN ROUTINE OVARIOHYSTERECTOMY VETERINARY PROCEDURE, WHERE THE DEVICE WAS USED FOR L IGATURES IN THE ABDOMEN, THERE WAS A SEVERE SUTURE REACTION. THE TISSUE WAS DAMAGE WITH EXCESSIVE NECROSIS AND INFLAMMATION WITH COCCI REQUIRED. THIS RESULTED IN ADDITIONAL SURGERIES THAT WERE CONSIDERED TOO EXTENSIVE TO PROCEED WITH, AS RESECTION OF THE COLON AND KIDNEY REMOVAL WERE REQUIRED. THE FAILED SURGERY RESULTED IN EUTHANASIA UNDER GENERAL ANESTHESIA.

  Patient problems: Inflammation; Insufficient Information; Necrosis

  MAUDE report 16396545 ↗
• MalfunctionFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 28 DAYS POST-OPERATIVELY OF A SPAY, THE CANINE PATIENT WAS SENT BACK TO THE VETERINARY HEALTHCARE FACILITY FOR BLOODY DISCHARGE FROM THE UTERUS. THE PATIENT WAS RE-OPERATED AND IT WAS THEN REVEALED THAT GRANULOMA IN THE AREA WHERE THE SUTURE WAS PLACED.

  Patient problems: Granuloma; Hematuria

  MAUDE report 16394194 ↗
• MalfunctionFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 35 DAYS POST-OPERATIVELY OF A SPAY, THE CANINE PATIENT WAS SENT BACK TO THE VETERINARY HEALTHCARE FACILITY FOR HIGH TEMPERATURE. BLOOD TEST SHOWED SIGNS OF INFECTION. THE PATIENT WAS TREATED WITH MEDICATION AND SENT BACK HOME, BUT CAME BACK AGAIN AFTER 4 DAYS WITH DIARRHEA, HIGH TEMPERATURE, AND SIGNS OF INFECTION IN BLOOD TEST. SCAN WAS PERFORMED, SHOWING A MASS IN THE ABDOMEN. THE PATIENT WAS THUS OPERATED. HUGE INFECTION AND ABDOMINAL MASS WAS FOUND IN THE AREA AROUND UTERINE STUMP WHERE THE SUTURE WAS PLACED. THE INFECTION ALSO CAUSED INFLAMMATION IN THE URINARY BLADDER AND COLON; THUS, COLECTOMY WAS PERFORMED. THE PATIENT DIED.

  Patient problems: Diarrhea; Fever; Inflammation; Unspecified Infection

  MAUDE report 16371304 ↗
• MalfunctionAug 8, 2018Break; Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD HERNIA REPAIR. THE PATIENT WAS A LITTLE PUFFY, HAD REALLY SWOLLEN UP, HAD DIARRHEA AND HAD POSSIBLE HERNIA AS SWELLING REDUCIBLE INTO THE ABDOMEN. THE PATIENT WAS INTUBATED AND WAS PROVIDED INTRAVENOUS INDUCTION. THE INTRADERMAL LAYER HELD WELL AND THE TOP BOTTOM OF THE INCISION SITE APPEARED TO BE SLIGHTLY INFECTED. THE SUTURE MATERIAL HAVE SNAPPED. THE MUSCLE LAYER WAS CLOSED AND PROVIDED MEDICATION.

  Patient problems: Diarrhea; Hernia; No Code Available; Swelling; Unspecified Infection

  MAUDE report 7765124 ↗
• MalfunctionAug 8, 2018Unraveled Material; Detachment of Device or Device Component; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD HERNIA SPRAY REPAIR. THE SKIN ALONG THE ORIGINAL WOUND WAS OPENED. THE MUSCLE LAYER WAS COMPLETELY OPEN DUE TO THE DEVICE KNOT UNTYING AT END. THE EDGE OF THE MUSCLE LAYER WAS FRESHENED AND SKIN EDGES. SKIN CLOSURE WAS PERFORMED AND MEDICATION WAS PROVIDED. AFTER 10 DAYS, THE STITCHES WERE REMOVED, THE CRANIAL END OF WOUND WAS VERY SORE AND BLEEDING A LITTLE.

  Patient problems: Discomfort; Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Hernia; No Code Available; Swelling

  MAUDE report 7765093 ↗
• MalfunctionAug 8, 2018Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD HERNIA REPAIR BECAUSE THERE WAS SWELLING AT THE INCISION SITE. THE LINEAR WOUND WAS CRANIAL TO SUTURE LINE, KNOT UNTIED CAUDALLY, THE RETAINED MATERIAL WAS REMOVED. THE WOUND EDGES WERE DEBRIDED AND FLUSHED.

  Patient problems: Hernia; No Code Available; Swelling

  MAUDE report 7765076 ↗
• MalfunctionAug 8, 2018Break; Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD PALP CAUDAL WOUND HERNIA. THE SURGICAL WOUND WAS OPENED AND THE SUTURE HAS BROKEN AND THE KNOT WAS IN TACT. ALL PREVIOUS SUTURE MATERIALS FRESH EDGES HAVE BEEN REMOVED AND RE SUTURED LINES AND CLOSED THE SKIN. THE PATIENT WAS ON ABSOLUTE BED REST WITH BUSTER COLLAR AND WAS PROVIDED MEDICATION.

  Patient problems: Hernia; No Code Available

  MAUDE report 7765036 ↗
• MalfunctionAug 8, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT PRESENTED WITH SPAY WOUND HERNIA. THE OMENTUM WAS FLUSHED IN SURGERY, THE INCISION EXTENDED CAUDALLY AND CRANIALLY, THE OMENTUM MOVED FROM THE INTESTINES AND THE LENGTH OF THE EXPOSED INTESTINE APPEARED HEALTHY. THE MUSCLE LAYER WAS CLOSED WITH THE DEVICE.

  Patient problems: Hernia; No Code Available

  MAUDE report 7764418 ↗
• MalfunctionAug 8, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD HERNIA REPAIR BECAUSE THE INCISION SITE WAS SWOLLEN. THE SURGEON INCISED THE SKIN HERNIATION THRU SUTURE GAPS, THE SUTURE KNOTS WERE INTACT. ALL SUTURE MATERIALS WERE REOPENED, FRESH EDGES. SKIN CLOSURE WAS PERFORMED. THE PATIENT WAS ON STRICT HOME BED REST AND WAS PROVIDED ANALGESICS.

  Patient problems: No Code Available; Swelling

  MAUDE report 7763028 ↗

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: