Maxon 8886 6233-51Recalls & 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 Maxon monofilament absorbable suture is used to close surgical wounds. Most of the 59 reports describe the needle coming loose from the suture thread during stitching, and thread breaking at the needle base, sometimes before use. Four reports involve injuries and no deaths are described. 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
- 58
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884523002430), received between Oct 4, 2017 and Jul 28, 2026 — classified as 4 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (44 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 Component44
- Break9
- Insufficient Device Problem Information8
- No Apparent Adverse Event6
- Unraveled Material5
- Adverse Event Without Identified Device or Use Problem3
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information21
- Hernia5
- No Code Available5
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- No Information2
- Radiation Exposure, Unintended2
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50061557 ↗MalfunctionJul 28, 2026Detachment of Device or Device Component
It was reported that during a veterinary procedure, a needle detachment from the suture was observed while suturing. New suture was used to resolve the issue in order to complete the case. There was no patient injury.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50061405 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE NEEDLE DETACHED FROM THE SUTURE WITHOUT ANY FORCE BEING APPLIED. TWO DEFECTIVE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886605 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH), THE NEEDLE DETACHED FROM THE SUTURE WITHOUT ANY FORCE BEING APPLIED. TWO DEFECTIVE SUTURES FROM THE SAME PRODUCT AND LOT NUMBER WERE INVOLVED DURING THE SAME EVENT WITH THE SAME PATIENT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886584 ↗MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT THE SURGEON CLAIMED THAT THE SUTURE WAS MORE RIGID THAN ANOTHER MANUFACTURER'S SUTURE, THE SUTURE BREAKS AND IS DIFFICULT TO HANDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22700960 ↗MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURE WAS BREAKING OFF AT THE NEEDLE BASE (SWEDGE). TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21432036 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, PRIOR TO THE PATIENT'S USE, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON 15 DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405390 ↗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 PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON FOUR DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21404906 ↗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 SUTURES WERE BREAKING OFF AT THE NEEDLE. THIS ISSUE OCCURRED ON 15 DEVICES.
Patient problems: Insufficient Information
MAUDE report 21403822 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, PRIOR TO THE PATIENT'S USE, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON 15 DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21403757 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON FOUR DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21403308 ↗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 PROCEDURE, PRIOR TO THE PATIENT'S USE, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON 15 DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21402776 ↗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 PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON FOUR DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21402750 ↗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 PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON FOUR DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21402480 ↗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 PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON FOUR DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21402427 ↗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 PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON FOUR DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 21402232 ↗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 SUTURES WERE BREAKING OFF AT THE NEEDLE. THIS ISSUE OCCURRED ON 15 DEVICES.
Patient problems: Insufficient Information
MAUDE report 21401715 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, PRIOR TO THE PATIENT'S USE, AFTER OPENING THE PACKAGING, THE SUTURES WERE BREAKING OFF AT THE NEEDLE BASE (SWEDGE). THIS ISSUE OCCURRED ON FOUR DEVICES. TO RESOLVE THE ISSUE, ANOTHER PACKAGE OF SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21401674 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event
ACCORDING TO THE REPORTER, THE SUTURES WERE BREAKING OFF AT THE NEEDLE. THIS ISSUE OCCURRED ON 15 DEVICES.
Patient problems: Insufficient Information
MAUDE report 21401524 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event
ACCORDING TO THE REPORTER, THE SUTURES WERE BREAKING OFF AT THE NEEDLE. THIS ISSUE OCCURRED ON 15 DEVICES.
Patient problems: Insufficient Information
MAUDE report 21401220 ↗MalfunctionFeb 18, 2025Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event
ACCORDING TO THE REPORTER, THE SUTURES WERE BREAKING OFF AT THE NEEDLE. THIS ISSUE OCCURRED ON 15 DEVICES.
Patient problems: Insufficient Information
MAUDE report 21393449 ↗MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, SEVERAL NEEDLES WERE DETACHED FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 21298270 ↗MalfunctionJan 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, SEVERAL NEEDLES WERE DETACHED FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 21191166 ↗MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SACROCOLPOPEXY PROCEDURE, THE TWO NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE FELL INTO THE PATIENT CAVITY, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 30 MINUTES. THE NEEDLE WAS SUCCESSFULLY RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21086196 ↗MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A B (BILATERAL) MASTECTOMY PROCEDURE, WHILE SUTURING THE CELLULAR MATRIX INTO THE BREAST, THE NEEDLE SEPARATED FROM THE THREAD. THE ISSUE OCCURRED IN 4 SUTURES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19955273 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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