Maxon 8886 6641-51Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
All models of Maxon (114)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Covidien Maxon absorbable synthetic suture, a stitch used to close surgical wounds. The 44 reports mostly describe the suture thread breaking during surgery, coming apart or pulling away from the needle, and in some cases wound or tissue reopening so the closure had to be redone. No deaths and no injuries were reported, and no recalls name this device. Reports fell from 24 in the prior 12 months to 5 in the most recent 12 months.
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
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10884523004168), received between Aug 27, 2017 and Jun 1, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (27 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component27
- Insufficient Device Problem Information14
- Break9
- Adverse Event Without Identified Device or Use Problem6
- Unraveled Material5
Patient problems
- Insufficient Information25
- Hernia8
- No Clinical Signs, Symptoms or Conditions6
- Wound Dehiscence4
- Organ Dehiscence2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Laceration(s)1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Unraveled Material
IT WAS REPORTED THAT WITHIN 12¿36 HOURS AFTER VETERINARY SURGERY, THE SUTURE LINE DID NOT HOLD. IT WAS REPORTED THAT RE-SUTURING WAS REQUIRED TO RESOLVE THE ISSUE.
Patient problems: Wound Dehiscence
MAUDE report 25353455 ↗MalfunctionJun 1, 2026Unraveled Material
IT WAS REPORTED THAT WITHIN 12¿36 HOURS AFTER VETERINARY SURGERY, THE SUTURE LINE DID NOT HOLD. IT WAS REPORTED THAT RE-SUTURING WAS REQUIRED TO RESOLVE THE ISSUE.
Patient problems: Wound Dehiscence
MAUDE report 25353410 ↗MalfunctionJun 1, 2026Unraveled Material
IT WAS REPORTED THAT WITHIN 12¿36 HOURS AFTER VETERINARY SURGERY, THE SUTURE LINE DID NOT HOLD. IT WAS REPORTED THAT RE-SUTURING WAS REQUIRED TO RESOLVE THE ISSUE.
Patient problems: Wound Dehiscence
MAUDE report 25345784 ↗MalfunctionFeb 27, 2026Break
ACCORDING TO THE REPORTER, THE DOCTOR PULLED OUT ONE PACK OF SUTURE FROM THE BOX AND IT BROKE RIGHT AWAY WHEN THE USER TRIED TO USE.
Patient problems: Insufficient Information
MAUDE report 24466803 ↗MalfunctionJan 30, 2026Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SUTURING, THE SUTURE THREAD BROKE FROM THE LIGATION PART. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228805 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE KEEPS COMING OFF THE NEEDLE. THIS ISSUE OCCURRED ON FOUR PACKS.
Patient problems: Insufficient Information
MAUDE report 22342879 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE KEEPS COMING OFF THE NEEDLE. THIS ISSUE OCCURRED ON FOUR PACKS.
Patient problems: Insufficient Information
MAUDE report 22342875 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE KEEPS COMING OFF THE NEEDLE. THIS ISSUE OCCURRED ON FOUR PACKS.
Patient problems: Insufficient Information
MAUDE report 22342872 ↗MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SUTURE KEEPS COMING OFF THE NEEDLE. THIS ISSUE OCCURRED ON FOUR PACKS.
Patient problems: Insufficient Information
MAUDE report 22342870 ↗MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A FELINE SPAY PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21472342 ↗MalfunctionFeb 26, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A FELINE SPAY PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21472044 ↗MalfunctionFeb 26, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A FELINE SPAY PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21471408 ↗MalfunctionFeb 26, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A FELINE SPAY PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21471055 ↗MalfunctionFeb 26, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A FELINE SPAY PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21470968 ↗MalfunctionFeb 26, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE CAME OFF THE SUTURE WHILE SUTURING FOR ALL 8 DEVICE.
Patient problems: Insufficient Information
MAUDE report 21470952 ↗MalfunctionFeb 21, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A FELINE SPAY PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21434786 ↗MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A FELINE SPAY PROCEDURE, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21434758 ↗MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, IN A SPAY AND NEUTER PROCEDURE, DURING SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407874 ↗MalfunctionFeb 19, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A VETERINARY MASS REMOVAL, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21407621 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE NEEDLES OF FOUR SUTURES FROM THE SAME LOT NUMBER CAME OFF. SIX MORE NEEDLES FROM ANOTHER LOT HAD THE SAME ISSUE.
Patient problems: Insufficient Information
MAUDE report 21407055 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE NEEDLES OF FOUR SUTURES FROM THE SAME LOT NUMBER CAME OFF. SIX MORE NEEDLES FROM ANOTHER LOT HAD THE SAME ISSUE.
Patient problems: Insufficient Information
MAUDE report 21407033 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE NEEDLES OF FOUR SUTURES FROM THE SAME LOT NUMBER CAME OFF. SIX MORE NEEDLES FROM ANOTHER LOT HAD THE SAME ISSUE.
Patient problems: Insufficient Information
MAUDE report 21401072 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A VETERINARY MASS REMOVAL, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21399794 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A VETERINARY MASS REMOVAL, WHILE SUTURING, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21398633 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE NEEDLES OF FOUR SUTURES FROM THE SAME LOT NUMBER CAME OFF. SIX MORE NEEDLES FROM ANOTHER LOT HAD THE SAME ISSUE.
Patient problems: Insufficient Information
MAUDE report 21392891 ↗
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:
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page