Maxon 8886 6639-41Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
All models of Maxon (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Maxon monofilament absorbable suture, made by Covidien LP, has 103 adverse event reports mentioning its identifier: no deaths and one injury. Reports mostly describe needle or part detachment, unraveling and breakage during surgery, sometimes followed by the suture line opening after the procedure. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10884523004144), received between Oct 5, 2017 and Jun 8, 2026 — classified as 1 injury, 102 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (85 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component85
- Unraveled Material9
- Break7
- Adverse Event Without Identified Device or Use Problem6
- Degraded1
- Detachment Of Device Component1
- Device Slipped1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- Insufficient Information46
- No Consequences Or Impact To Patient9
- Wound Dehiscence8
- No Patient Involvement6
- Tissue Breakdown5
- Hernia4
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY CASE, THREE NEEDLES BROKE OFF FROM THE SUTURE DURING SURGERY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429223 ↗MalfunctionJun 8, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY CASE, THREE NEEDLES BROKE OFF FROM THE SUTURE DURING SURGERY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428983 ↗MalfunctionJun 5, 2026Unraveled Material
IT WAS REPORTED THAT FIVE MASSES WERE REMOVED ON A CANINE UNDER GENERAL ANESTHESIA. WITHIN TWENTY-FOUR HOURS POSTOPERATIVELY, THE SUTURE LINE DID NOT HOLD AND ALL FIVE SUTURE SITES OPENED UP. AN ADDITIONAL ANESTHETIC SURGERY WAS PERFORMED TO REPAIR ALL FIVE INCISION SITES.
Patient problems: Tissue Breakdown
MAUDE report 25404989 ↗MalfunctionJun 5, 2026Unraveled Material
IT WAS REPORTED THAT FIVE MASSES WERE REMOVED ON A CANINE UNDER GENERAL ANESTHESIA. WITHIN TWENTY-FOUR HOURS POSTOPERATIVELY, THE SUTURE LINE DID NOT HOLD AND ALL FIVE SUTURE SITES OPENED UP. AN ADDITIONAL ANESTHETIC SURGERY WAS PERFORMED TO REPAIR ALL FIVE INCISION SITES.
Patient problems: Tissue Breakdown
MAUDE report 25404962 ↗MalfunctionJun 5, 2026Unraveled Material
IT WAS REPORTED THAT FIVE MASSES WERE REMOVED ON A CANINE UNDER GENERAL ANESTHESIA. WITHIN TWENTY-FOUR HOURS POSTOPERATIVELY, THE SUTURE LINE DID NOT HOLD AND ALL FIVE SUTURE SITES OPENED UP. AN ADDITIONAL ANESTHETIC SURGERY WAS PERFORMED TO REPAIR ALL FIVE INCISION SITES.
Patient problems: Tissue Breakdown
MAUDE report 25404924 ↗MalfunctionJun 5, 2026Unraveled Material
IT WAS REPORTED THAT FIVE MASSES WERE REMOVED ON A CANINE UNDER GENERAL ANESTHESIA. WITHIN TWENTY-FOUR HOURS POSTOPERATIVELY, THE SUTURE LINE DID NOT HOLD AND ALL FIVE SUTURE SITES OPENED UP. AN ADDITIONAL ANESTHETIC SURGERY WAS PERFORMED TO REPAIR ALL FIVE INCISION SITES.
Patient problems: Tissue Breakdown
MAUDE report 25404886 ↗MalfunctionJun 5, 2026Unraveled Material
IT WAS REPORTED THAT FIVE MASSES WERE REMOVED ON A CANINE UNDER GENERAL ANESTHESIA. WITHIN TWENTY-FOUR HOURS POSTOPERATIVELY, THE SUTURE LINE DID NOT HOLD AND ALL FIVE SUTURE SITES OPENED UP. AN ADDITIONAL ANESTHETIC SURGERY WAS PERFORMED TO REPAIR ALL FIVE INCISION SITES.
Patient problems: Tissue Breakdown
MAUDE report 25404877 ↗MalfunctionMay 29, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY CASE, THREE NEEDLES BROKE OFF FROM THE SUTURE DURING SURGERY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326943 ↗MalfunctionMay 29, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY CASE, THREE NEEDLES BROKE OFF FROM THE SUTURE DURING SURGERY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326933 ↗MalfunctionMay 29, 2026Detachment of Device or Device Component
ACCORDING TO A VETERINARY CASE, THREE NEEDLES BROKE OFF FROM THE SUTURE DURING SURGERY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326910 ↗MalfunctionMay 6, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POSTOPERATIVE WOUND DEHISCENCE OCCURRED FOLLOWING A VETERINARY PROCEDURE, NECESSITATING EMERGENCY SURGERY, AND RESULTED IN DEATH.
Patient problems: Wound Dehiscence
MAUDE report 25104970 ↗MalfunctionMay 5, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST-OPERATIVE WOUND DEHISCENCE OCCURRED AFTER A VETERINARY PROCEDURE, NECESSITATING EMERGENCY SURGERY.
Patient problems: Wound Dehiscence
MAUDE report 25081154 ↗MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POSTOPERATIVE WOUND DEHISCENCE OCCURRED AFTER A VETERINARY PROCEDURE, NECESSITATING EMERGENCY SURGERY.
Patient problems: Wound Dehiscence
MAUDE report 25075547 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
IT WAS REPORTED, THAT IN A VETERINARY PROCEDURE, IN THE THREE DEVICES, THE THREAD PULLED OFF THE NEEDLE WITH VERY LITTLE TENSION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24123224 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
IT WAS REPORTED, THAT IN A VETERINARY PROCEDURE, IN THE THREE DEVICES, THE THREAD PULLED OFF THE NEEDLE WITH VERY LITTLE TENSION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24123218 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
IT WAS REPORTED, THAT IN A VETERINARY PROCEDURE, IN THE THREE DEVICES, THE THREAD PULLED OFF THE NEEDLE WITH VERY LITTLE TENSION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24123186 ↗MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE VETERINARY REPORT, THE NEEDLE CAME OFF THE SUTURE.
Patient problems: Insufficient Information
MAUDE report 23569339 ↗MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, FOR A SPAY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22078825 ↗MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, FOR A SPAY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22062677 ↗MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, FOR A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22062333 ↗MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, FOR A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22062169 ↗MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, FOR A SPAY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22062122 ↗MalfunctionMay 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, FOR A SPAY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22060184 ↗MalfunctionMay 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21947946 ↗MalfunctionMay 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, FOR A SPAY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. THE CUSTOMER ALSO REPORTED THAT THIS WAS APPROXIMATELY THE SIXTH OR SEVENTH OCCURRENCE OF THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21947916 ↗
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 · TerminatedSutures. 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:
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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