Maxon 8886621741-2Recalls & 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 is a Covidien absorbable synthetic suture, a single-use monofilament stitch used to close surgical wounds. The 27 reports mostly describe the needle coming loose from the thread during suturing, and in a few cases the needle fell into the patient's body cavity and had to be located with X-rays and removed, which lengthened the operation. There are 3 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
- 27
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521757851), received between Mar 8, 2022 and Aug 25, 2026 — classified as 3 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (26 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 Component26
- Break1
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information10
- Unintended Radiation Exposure3
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Detachment of Device or Device Component
According to the reporter, during a veterinary procedure, the needle was detached while removing from the retainer. A new suture was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50433041 ↗MalfunctionJun 16, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUTURING, THE NEEDLE WAS DETACHED.
Patient problems: Insufficient Information
MAUDE report 25520286 ↗MalfunctionJun 16, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUTURING, THERE HAVE BEEN SEVERAL INSTANCES WHERE THE NEEDLE SUTURE WAS DETACHED, BUT THE PRODUCT HAS BEEN DISCARDED AND CANNOT BE RETURNED.
Patient problems: Insufficient Information
MAUDE report 25520193 ↗MalfunctionJun 16, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUTURING, THERE HAVE BEEN SEVERAL INSTANCES WHERE THE NEEDLE SUTURE WAS DETACHED, BUT THE PRODUCT HAS BEEN DISCARDED AND CANNOT BE RETURNED.
Patient problems: Insufficient Information
MAUDE report 25520085 ↗InjuryJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING AFTER THE PATIENT INCISION. THE NEEDLE SUBSEQUENTLY FELL INTO THE PATIENT CAVITY, WHICH REQUIRED RETRIEVAL. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE AND THE NEEDLE WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE TIME WAS EXTENDED DUE TO THIS ISSUE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Unintended Radiation Exposure
MAUDE report 22563563 ↗InjuryJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE SUTURE. IT WAS NOTED THAT THE NEEDLE WAS SEARCHED FOR AND RECOVERED FROM THE PATIENT'S ABDOMEN.
Patient problems: Insufficient Information; Unintended Radiation Exposure
MAUDE report 22524607 ↗MalfunctionApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR A VETERINARY PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD DETACHED FOUR TIMES IN A ROW DURING NORMAL SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175696 ↗MalfunctionApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR A VETERINARY PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD DETACHED FOUR TIMES IN A ROW DURING NORMAL SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175645 ↗MalfunctionApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR A VETERINARY PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD DETACHED FOUR TIMES IN A ROW DURING NORMAL SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175624 ↗MalfunctionApr 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR A VETERINARY PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD DETACHED FOUR TIMES IN A ROW DURING NORMAL SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175578 ↗MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PREPARATION, AFTER OPENING THE NEEDLE HAD DETACHED INSIDE THE PACKAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18754217 ↗MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PREPARATION, AFTER OPENING THE NEEDLE HAD DETACHED INSIDE THE PACKAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18754211 ↗MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR A VETERINARY PROCEDURE, WHILE PERFORMING A SUTURE OPERATION, THE NEEDLE AND THREAD BECAME DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17942319 ↗MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR A VETERINARY PROCEDURE, WHILE PERFORMING A SUTURE OPERATION, THE NEEDLE AND THREAD BECAME DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17941108 ↗MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVE OF A VETERINARY PROCEDURE, THE SUTURE THREAD AND NEEDLE WERE DISCONNECTED WHEN IT WAS UNPACKED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17472832 ↗InjuryApr 24, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A ORTHOPEDIC SURGERY, WHEN SUTURING DURING ABDOMINAL CLOSURE, THE SURGEON CHECKED THAT THE TIP OF THE NEEDLE WAS CHIPPED, THE NEEDLE TIP COULD NOT BE FOUND, AND THE ABDOMEN WAS CLOSED. A CT SCAN WAS PERFORMED TO IDENTIFY THE POSITION OF THE NEEDLE, AND IT WAS DISCOVERED THAT APPROXIMATELY 2.1MM OF THE NEEDLE TIP WAS LEFT BEHIND AT A DEPTH OF 5MM BELOW THE SKIN. AN ADDITIONAL SURGERY WILL BE PERFORMED TO CORRECT THE PROBLEM.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 16796408 ↗MalfunctionMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVE TO VETERINARY CASE, THE THREAD AND NEEDLE CAME OFF. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16601552 ↗MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY LAPAROTOMY CONTRACEPTIVE, FOR SURGICAL INCISION CLOSURE, THE SUTURE SLIPPED OUT OF THE NEEDLE'S SUTURE PART. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16545944 ↗MalfunctionFeb 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE TWO NEEDLES CAME OFF THE THREAD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 16364416 ↗MalfunctionFeb 8, 2023Device Slipped; Device Slipped
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHEN THE NEEDLE WAS PULLED THROUGH THE TISSUE, THE SUTURE SLIPPED OUT OF THE NEEDLE'S THREADING AREA. ANOTHER PACKET WAS OPENED, BUT IT SLIPPED OUT IN THE SAME WAY. THE THIRD PACKET COULD BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16327152 ↗MalfunctionDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY LAPAROTOMY CONTRACEPTIVE PROCEDURE, WHEN SURGICAL INCISION CLOSURE PERFORMED, THE FIRST SUTURE CAME OFF FROM THE NEEDLE AFTER SUTURE WAS DONE. THE SECOND SUTURE, WHEN IT WAS TAKEN OUT, THE NEEDLE CAME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15992078 ↗MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, TEN SECONDS AFTER THE PACKAGING WAS OPENED, THE THREAD AND THE NEEDLE HAD CAME OFF. A NEW SUTURE OF THE SAME TYPE AND LOT NUMBER WAS USED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15738370 ↗MalfunctionAug 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS NOT USED AS BOTH NEEDLE AND THREAD KEPT COMING OFF EVEN THOUGH IT WAS NOT D-TACH. A DIFFERENT SUTURE WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 15279583 ↗MalfunctionJul 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, ALL OF THE THREAD THAT WERE TAKEN OUT FROM THE PACKETS WERE FOUND TO CAME OFF FROM THE SWAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15067317 ↗MalfunctionJun 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PET STERILIZATION, WHEN CLOSING THE SURGICAL INCISION, ALL OF THE THREAD THAT WERE TAKEN OUT FROM THE FOUR PACKETS WERE FOUND TO CAME OFF FROM THE SWAGE. A NEW PACKET WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENTINJURY.
Patient problems: Insufficient Information
MAUDE report 14758976 ↗
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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