Caprosyn UC-203Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture,CV-23,1x Undyed Strand · Class 2 · Implant
All models of Caprosyn (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521035089), received between Feb 8, 2021 and Aug 29, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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. 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
- Patient-Device Incompatibility2
- Break1
- Detachment of Device or Device Component1
Patient problems
- Unspecified Infection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION FOLLOWING THE USE OF THE SUTURE DURING A NECK DISSECTION. MEDICATION WAS REQUIRED AS AN INTERVENTION FOR THE INFECTION. IT WAS NOTED THAT SUTURES WERE REMOVED AND THE SITE WAS CLEANED.
Patient problems: Unspecified Infection
MAUDE report 22920643 ↗InjuryAug 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INFECTION FOLLOWING THE USE OF THE SUTURE DURING A NECK DISSECTION. MEDICATION WAS REQUIRED AS AN INTERVENTION FOR THE INFECTION. IT WAS NOTED THAT SUTURES WERE REMOVED AND THE SITE WAS CLEANED.
Patient problems: Unspecified Infection
MAUDE report 22889587 ↗MalfunctionFeb 8, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A BILATERAL BREAST LUMP PROCEDURE, THE NEEDLE BROKE AND FELL INSIDE THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO FIND IT WITHOUT THE ASSISTANCE OF X-RAY AT THE END. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11292501 ↗
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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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