Maxon 8886 6233-41Recalls & 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 Covidien Maxon absorbable suture is a synthetic thread that dissolves in the body over time. Its 149 reports mostly describe the needle coming off the suture, the thread breaking, and the suture slipping during use. The reports include 6 injuries and no deaths. No recalls name 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
- 152
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10884523002423), received between Jul 11, 2017 and Sep 29, 2026 — classified as 6 injuries, 146 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (97 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 Component97
- Break60
- Device Slipped19
- Adverse Event Without Identified Device or Use Problem5
- Insufficient Device Problem Information3
- Detachment Of Device Component2
- Material Twisted/Bent2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- Insufficient Information37
- No Consequences Or Impact To Patient25
- No Known Impact Or Consequence To Patient17
- Unspecified Infection3
- No Code Available2
- No Patient Involvement2
- Granuloma1
Recent adverse event reports
The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926991 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926983 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
It was reported that during a veterinary procedure, during suturing, the needle detached from the suture. The needle did not fall into the patient cavity. 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 50819926 ↗MalfunctionAug 31, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50526403 ↗MalfunctionAug 25, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50433981 ↗MalfunctionAug 25, 2026Detachment of Device or Device Component
According to the reporter, during a veterinary surgery, the two needles were popping off from the suture.
Patient problems: Insufficient Information
MAUDE report 50433964 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50309187 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50309169 ↗MalfunctionJul 31, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50104309 ↗MalfunctionJun 16, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING AN OVARIOHYSTERECTOMY VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25514497 ↗MalfunctionJun 3, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25370759 ↗MalfunctionJun 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25362200 ↗MalfunctionJun 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25362078 ↗MalfunctionJun 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25362007 ↗MalfunctionMay 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT PREOPERATIVE TO A VETERINARY PROCEDURE, WHEN SUTURES WERE BEING REMOVED FROM THE RETAINER OR WHEN PREPARING SUTURE PRIOR TO PATIENT INCISION, NEEDLES KEPT POPPING OFF. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278583 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT DURING A BYPASS PROCEDURE, THE THREAD BROKE IN THE MIDDLE WHILE SUTURING FOR ANASTOMOSIS CLOSURE. IT WAS FURTHER REPORTED THAT THE SUTURE HAD LESS STRENGTH AND BROKE WITH MINIMAL TENSION. 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 25051742 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL CASE, SUTURES WERE POPPING OFF FROM THEIR NEEDLES. TWO ADDITIONAL BOXES WERE OPENED AND SIMILAR FAULTY SUTURES WERE OBSERVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867418 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL CASE, SUTURES WERE POPPING OFF FROM THEIR NEEDLES. TWO ADDITIONAL BOXES WERE OPENED AND SIMILAR FAULTY SUTURES WERE OBSERVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867413 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL CASE, SUTURES WERE POPPING OFF FROM THEIR NEEDLES. TWO ADDITIONAL BOXES WERE OPENED AND SIMILAR FAULTY SUTURES WERE OBSERVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867405 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL CASE, SUTURES WERE POPPING OFF FROM THEIR NEEDLES. TWO ADDITIONAL BOXES WERE OPENED AND SIMILAR FAULTY SUTURES WERE OBSERVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867404 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL CASE, SUTURES WERE POPPING OFF FROM THEIR NEEDLES. TWO ADDITIONAL BOXES WERE OPENED AND SIMILAR FAULTY SUTURES WERE OBSERVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867399 ↗MalfunctionMar 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SUTURING, THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. 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 24638223 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWO SUTURES FROM THE SAME LOT WERE FOUND TO HAVE A NEEDLE DETACHING VERY EASILY FROM THE THREAD, AS IF IT WERE A D-TACH. AS A RESULT OF THE DETACHMENT, THE SUTURE COULD NOT BE REUSED, AND THE STITCHES HAD TO BE REDONE BECAUSE THERE WAS NO LONGER A NEEDLE ATTACHED TO INSERT INTO THE SKIN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24478762 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWO SUTURES FROM THE SAME LOT WERE FOUND TO HAVE A NEEDLE DETACHING VERY EASILY FROM THE THREAD, AS IF IT WERE A D-TACH. AS A RESULT OF THE DETACHMENT, THE SUTURE COULD NOT BE REUSED, AND THE STITCHES HAD TO BE REDONE BECAUSE THERE WAS NO LONGER A NEEDLE ATTACHED TO INSERT INTO THE SKIN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24478544 ↗MalfunctionFeb 19, 2026Break; Device Slipped
IT WAS REPORTED THAT DURING A PROCEDURE, THE THREAD WAS BROKEN WHILE SUTURING. ADDITIONALLY, THE KNOTS WAS DISASSEMBLED AS WELL.
Patient problems: Insufficient Information
MAUDE report 24393114 ↗
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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