Caprosyn GC-122Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Caprosyn GC-122 is an absorbable synthetic suture used to close wounds. The 39 reports mostly describe the thread breaking or tearing as it was pulled from the package or handled, and needles coming apart from the thread before use; several were in animal surgery. No deaths and no injuries 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
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10884521034426), received between Jan 24, 2019 and Mar 28, 2024 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Break” (37 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
- Break37
- Insufficient Device Problem Information11
- Detachment of Device or Device Component3
Patient problems
- Insufficient Information30
- No Clinical Signs, Symptoms or Conditions19
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY. THE DEVICE WAS RECEIVED WITHOUT ACCOMPANYING INFORMATION.
Patient problems: Insufficient Information
MAUDE report 19000489 ↗MalfunctionMar 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, AT THE MOMENT TO OPEN THE DEVICE, WHEN THE SURGEONS OPENED THE SUTURE BOX TO USE THEM, THEY REALIZED THAT THE 36 NEEDLES WERE SEPARATED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 18823151 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18700438 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY. THE DEVICE WAS RECEIVED WITHOUT ACCOMPANYING INFORMATION.
Patient problems: Insufficient Information
MAUDE report 18700344 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18700335 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18700325 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18700320 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18700315 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 17 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18700275 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18700223 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18697494 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18697483 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18697475 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18696672 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18696666 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18696664 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18696660 ↗MalfunctionFeb 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, IT WAS NOTED THAT AS SOON AS THE CUSTOMER TOOK THE 18 SUTURES OUT OF THE PACKAGING, IT TORE IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 18696659 ↗MalfunctionFeb 6, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY FOR A VETERINARIAN, THE THREAD WAS TORN IN THE MIDDLE, AND THE NEEDLE WITH THE NEEDLE HOLDER WAS TAKEN OUT OF THE PACKAGING AND THEN TORN DIRECTLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18652123 ↗MalfunctionFeb 6, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PREOPERATIVELY FOR A VETERINARIAN, THE THREAD WAS TORN IN THE MIDDLE, AND THE NEEDLE WITH THE NEEDLE HOLDER WAS TAKEN OUT OF THE PACKAGING AND THEN TORN DIRECTLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18651368 ↗MalfunctionFeb 5, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PREOPERATIVELY FOR A VETERINARIAN, THE THREAD WAS TORN IN THE MIDDLE, AND THE NEEDLE WITH THE NEEDLE HOLDER WAS TAKEN OUT OF THE PACKAGING AND THEN TORN DIRECTLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18647736 ↗MalfunctionFeb 5, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PREOPERATIVELY FOR A VETERINARIAN, THE THREAD WAS TORN IN THE MIDDLE, AND THE NEEDLE WITH THE NEEDLE HOLDER WAS TAKEN OUT OF THE PACKAGING AND THEN TORN DIRECTLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18647706 ↗MalfunctionFeb 5, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PREOPERATIVELY FOR A VETERINARIAN, THE THREAD WAS TORN IN THE MIDDLE, AND THE NEEDLE WITH THE NEEDLE HOLDER WAS TAKEN OUT OF THE PACKAGING AND THEN TORN DIRECTLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18647692 ↗MalfunctionFeb 5, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PREOPERATIVELY FOR A VETERINARIAN, THE THREAD WAS TORN IN THE MIDDLE, AND THE NEEDLE WITH THE NEEDLE HOLDER WAS TAKEN OUT OF THE PACKAGING AND THEN TORN DIRECTLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18647673 ↗MalfunctionFeb 5, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PREOPERATIVELY FOR A VETERINARIAN, THE THREAD WAS TORN IN THE MIDDLE, AND THE NEEDLE WITH THE NEEDLE HOLDER WAS TAKEN OUT OF THE PACKAGING AND THEN TORN DIRECTLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18647664 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.