Caprosyn SC-643Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Caprosyn absorbable surgical suture is a synthetic monofilament thread used to close wounds. Reports mostly describe the needle coming loose from the thread, sometimes even in the unopened package, and the thread snapping during suturing. There are 32 reports, with no deaths and no injuries. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521034969), received between Jan 27, 2020 and May 19, 2026 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component28
- Break4
- Insufficient Device Problem Information1
- Unraveled Material1
Patient problems
- Insufficient Information18
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient4
- No Information2
- No Patient Involvement2
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PACEMAKER INSERTION PROCEDURE, WITH AN EVENT IN WHICH ONE OF FIVE SUTURES WAS FOUND TO HAVE THE NEEDLE DETACHED PRIOR TO REMOVING IT FROM THE PACKAGE UPON OPENING. IT WAS FURTHER REPORTED THAT THE NEXT FOUR SUTURES DETACHED FROM THE NEEDLE WHILE BEING USED, THE BREAK OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND THAT THE SUTURE LINE DID NOT HOLD. THE PRODUCT WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 25216019 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PACEMAKER INSERTION PROCEDURE, WITH AN EVENT IN WHICH ONE OF FIVE SUTURES WAS FOUND TO HAVE THE NEEDLE DETACHED PRIOR TO REMOVING IT FROM THE PACKAGE UPON OPENING. IT WAS FURTHER REPORTED THAT THE NEXT FOUR SUTURES DETACHED FROM THE NEEDLE WHILE BEING USED, THE BREAK OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND THAT THE SUTURE LINE DID NOT HOLD. THE PRODUCT WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 25215938 ↗MalfunctionMay 19, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PACEMAKER INSERTION PROCEDURE, WITH AN EVENT IN WHICH ONE OF FIVE SUTURES WAS FOUND TO HAVE THE NEEDLE DETACHED PRIOR TO REMOVING IT FROM THE PACKAGE UPON OPENING. IT WAS FURTHER REPORTED THAT THE NEXT FOUR SUTURES DETACHED FROM THE NEEDLE WHILE BEING USED, THE BREAK OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND THAT THE SUTURE LINE DID NOT HOLD. THE PRODUCT WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 25215913 ↗MalfunctionMay 19, 2026Unraveled Material; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PACEMAKER INSERTION PROCEDURE, WITH AN EVENT IN WHICH ONE OF FIVE SUTURES WAS FOUND TO HAVE THE NEEDLE DETACHED PRIOR TO REMOVING IT FROM THE PACKAGE UPON OPENING. IT WAS FURTHER REPORTED THAT THE NEXT FOUR SUTURES DETACHED FROM THE NEEDLE WHILE BEING USED, THE BREAK OCCURRED AT THE CONNECTION OF THE NEEDLE AND THREAD, AND THAT THE SUTURE LINE DID NOT HOLD. THE PRODUCT WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 25215870 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, IN WOUND CLOSURE, THE THREAD CAME LOOSE FROM THE NEEDLE. ADDITIONALLY, ON ANOTHER SUTURE, THE THREAD BROKE IN HALF DURING SUTURING. ON THE THIRD SUTURE, THE NEEDLE COMES LOOSE FROM THE THREAD WHEN REMOVED FROM THE PACKAGING. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23342569 ↗MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, IN WOUND CLOSURE, THE THREAD CAME LOOSE FROM THE NEEDLE. ADDITIONALLY, ON ANOTHER SUTURE, THE THREAD BROKE IN HALF DURING SUTURING. ON THE THIRD SUTURE, THE NEEDLE COMES LOOSE FROM THE THREAD WHEN REMOVED FROM THE PACKAGING. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23342558 ↗MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, IN WOUND CLOSURE, THE THREAD CAME LOOSE FROM THE NEEDLE SEVERAL TIMES. ADDITIONALLY, ON THE THIRD DEVICE, THE THREAD BROKE IN HALF DURING SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 23342296 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, IN WOUND CLOSURE, THE THREAD CAME LOOSE FROM THE NEEDLE SEVERAL TIMES. ADDITIONALLY, ON THE THIRD DEVICE, THE THREAD BROKE IN HALF DURING SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT'S CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 23342161 ↗MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, IN WOUND CLOSURE, THE THREAD CAME LOOSE FROM THE NEEDLE SEVERAL TIMES. ADDITIONALLY, THE THREAD BROKE IN HALF DURING SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 23341912 ↗MalfunctionOct 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER INTRA-OPERATIVELY, THE NEEDLE DETACHED FROM THE THREAD WHILE SUTURING. MORE SUTURES WERE OPENED BUT THE SUTURES WERE NOT ATTACHED TO NEEDLE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23333590 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLES DETACHED FROM THE THREADS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23294173 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLES DETACHED FROM THE THREADS. 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 23292298 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLES DETACHED FROM THE THREADS. 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 23292259 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLES DETACHED FROM THE THREADS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23291936 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLES DETACHED FROM THE THREADS. 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 23288555 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER INTRA-OPERATIVELY, THE NEEDLES DETACHED FROM THE THREADS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23288454 ↗MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFTING, WHEN CLOSING THE PATIENT'S LEG, THE TWO SUTURE WAS SNAPPING AND ONE DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201713 ↗MalfunctionJun 13, 2025Break; Break
IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFTING, WHEN CLOSING THE PATIENT'S LEG, THE TWO SUTURE WAS SNAPPING AND ONE DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22201553 ↗MalfunctionJun 11, 2025Break; Break
IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFTING, WHEN CLOSING THE PATIENT'S LEG, THE TWO SUTURE WAS SNAPPING AND ONE DETACHED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22185623 ↗MalfunctionApr 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A KNEE REPLACEMENT, A NEEDLE DETACHED WHILE SUTURING/PREPARING THE SUTURE AFTER THE PATIENT INCISION. IT WAS NOT SPECIFIED IF THE NEEDLE FELL INTO THE PATIENT CAVITY. THE SURGEON NEEDED TO MANEUVER THE SITUATION AND BRING A REPLACEMENT COMPONENT TO FINISH THE SURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21937053 ↗MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD OF FOUR SUTURES DETACHED FROM THE NEEDLE DURING USE.
Patient problems: Insufficient Information
MAUDE report 21256940 ↗MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD OF FOUR SUTURES DETACHED FROM THE NEEDLE DURING USE.
Patient problems: Insufficient Information
MAUDE report 21256934 ↗MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD OF FOUR SUTURES DETACHED FROM THE NEEDLE DURING USE.
Patient problems: Insufficient Information
MAUDE report 21256885 ↗MalfunctionJan 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD OF FOUR SUTURES DETACHED FROM THE NEEDLE DURING USE.
Patient problems: Insufficient Information
MAUDE report 21256864 ↗MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, 8 SUTURING DEVICE HAD NEEDLE DETACHED FROM THE THREAD, AFTER OPENING THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10693343 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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