Caprosyn CC-905Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523004090), received between Jul 14, 2023 and Apr 2, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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
- Detachment of Device or Device Component3
- Break2
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unintended Radiation Exposure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING AFTER PATIENT INCISION, NEEDLE DETACHMENT OCCURRED. THE NEEDLE DID NOT FALL INTO THE PATIENTS CAVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24770130 ↗MalfunctionJan 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE NEEDLE POINT BROKE OFF AND FELL INTO THE PATIENT. THE NEEDLE TIP WAS ABLE TO BE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 18602269 ↗InjuryJul 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN HANDING THE SCRUB TECHNICIAN THE SUTURE NEEDLE FROM THE SURGEON, IT WAS NOTED THAT THE TIP WAS MISSING. X-RAY WAS READ BY THE SURGEON, AND NO NEEDLE TIP WAS SEEN ON THE X-RAY FILM.
Patient problems: Foreign Body In Patient; Unintended Radiation Exposure
MAUDE report 17325538 ↗
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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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