Maxon 8886 6207-31Recalls & 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 Covidien Maxon absorbable monofilament suture is used to close tissue during surgery. Most of the 31 reports describe the needle coming loose from the thread, sometimes before surgery even starts, and the thread breaking or fraying; in one case a needle was lost inside a patient's chest cavity and could not be found. There are 31 reports, no deaths and 1 injury. No recalls name this device, and the number of reports in the past 12 months is the same as the 12 months before.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884523002270), received between Jul 19, 2017 and Aug 11, 2026 — classified as 1 injury, 30 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component26
- Break5
- Material Frayed2
- Difficult to Open or Remove Packaging Material1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient5
- No Patient Involvement4
- Insufficient Information2
- Foreign Body In Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50204273 ↗MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, THE NEEDLE DETACHED FROM ALL 36 SUTURES.
Patient problems: Insufficient Information
MAUDE report 22007209 ↗InjuryJul 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN THORACIC PROCEDURE, AT THE TIME OF SUTURE APPLICATION, THE NEEDLE FELL AND WAS LOST IN THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE, BUT IT WAS NOT LOCATED. THE SURGEON CLOSED THE PATIENT WHILE THE NEEDLE REMAINS IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17373730 ↗MalfunctionMar 16, 2023Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE THREAD BROKE. A NEW SUTURE WAS USED FROM ANOTHER MANUFACTURER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16558226 ↗MalfunctionOct 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN SMALL BOWEL RESECTION, WHILE CLOSING THE TISSUE, THE NEEDLE DETACHED FROM THE THREAD ON THE FIRST STITCH. ANOTHER SUTURE WITH THE SAME LOT NUMBER WAS USED AND HAD THE SAME ISSUE. USED A THIRD SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15677369 ↗MalfunctionFeb 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN SMALL BOWEL RESECTION, WHILE CLOSING THE TISSUE, THE NEEDLE DETACHED FROM THE THREAD ON THE FIRST STITCH. ANOTHER SUTURE WITH THE SAME LOT NUMBER WAS USED AND HAD THE SAME ISSUE. USED A THIRD SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13534553 ↗MalfunctionFeb 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVE A GASTROJEJUNOSTOMY, THE SUTURE HAD ALREADY DETACHED FROM THE NEEDLE WHEN THE PACKAGE WAS OPENED. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13476399 ↗MalfunctionDec 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SUTURE WAS TAKEN OUT FROM THE PACKAGE USING A NEEDLE HOLDER AND THE NEEDLE DETACHED FROM THE THREAD. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13024692 ↗MalfunctionJul 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD HAD COME OFF FROM THE NEEDLE BEFORE SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12137368 ↗MalfunctionApr 12, 2021Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A TENDON REPAIR, THE SUTURE WAS BREAKING FROM THE SWAGE AND WAS FRAYING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11652777 ↗MalfunctionApr 12, 2021Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A TENDON REPAIR, THE SUTURE WAS BREAKING FROM THE SWAGE AND WAS FRAYING. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11652164 ↗MalfunctionMar 29, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, UPON TAKING OUT THE PRODUCT FROM THE PACKAGE, IT WAS FOUND THAT THE THREAD TAIL HAD SEALED TOGETHER ON THE INSIDE OF THE PACKAGE, PREVENTING THE NEEDLE AND THREAD FROM BEING REMOVED FROM THE PACKAGE. SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11580570 ↗MalfunctionFeb 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. THE PRODUCT WAS NOT USED TO THE PATIENT. THE SAME ISSUE OCCURRED IN TWO UNITS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11321628 ↗MalfunctionJan 15, 2021Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11177933 ↗MalfunctionNov 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED WHEN THE PACKET WAS OPENED. A NEW DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10786736 ↗MalfunctionJun 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING VETERINARY PROCEDURE, THE THREAD AND THE NEEDLE WERE FOUND TO BE COME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10132131 ↗MalfunctionFeb 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN OPENING THE PACKAGE AND TRYING TO TAKE THE DEVICE OUT DURING A LAPAROSCOPIC COLECTOMY, THE NEEDLE WAS FOUND TO BE DISENGAGED. THE PRODUCT WAS NOT USED TO THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9714451 ↗MalfunctionJan 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9648244 ↗MalfunctionDec 11, 2019Break; Break
ACCORDING TO THE REPORTER, DURING VETERINARY PROCEDURE, THE DEVICE THREAD BROKE EASILY WHILE SUTURING. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9449986 ↗MalfunctionNov 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, AS THE DEVICE WAS ABOUT TO BE USED, THE NEEDLE AND THREAD DISENGAGED. ANOTHER DEVICE WAS USED HOWEVER, THE DEVICE ALSO HAD ITS NEEDLE AND THREAD DISENGAGE DURING SUTURING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9357096 ↗MalfunctionOct 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A SEPTOPLASTY PROCEDURE, THE THREAD AND NEEDLE SEPARATED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9183948 ↗MalfunctionApr 8, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN SUTURING ON A LAPAROSCOPIC UROLOGY PROCEDURE, THE SURGEON EMPLOYED A RUNNING TECHNIQUE WHEN THE NEEDLE BROKE. THEY OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8494136 ↗MalfunctionMar 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, WHEN THE ALUMINUM PACKAGE WAS OPENED, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED AND WERE UNABLE TO BE USED IN CLINICS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8456169 ↗MalfunctionMar 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURED PULLED OFF THE NEEDLE.
Patient problems: No Information
MAUDE report 8441452 ↗MalfunctionMar 14, 2019Break; Break
ACCORDING TO THE REPORTER, DURING ROBOTIC ILLEACONDUIT PROCEDURE, 5 HOURS INTO THE PROCEDURE, THE THREAD BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8423316 ↗
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