Surgipro II VP558X-2Recalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro II (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521758698), received between Dec 30, 2020 and Nov 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIORRHAPHIES, THE TWO SUTURE BREAKS VERY EASILY, THE USER HAD TO MODIFY THE TECHNIQUE TO AVOID A POSSIBLE RECURRENCE; BY MODIFYING THE TECHNIQUE, THE PATIENT HAS BEEN ASLEEP FOR MORE THAN AN HOUR THAN SHE SHOULD HAVE AND HER SKIN HAS BEEN PRICKED SEVERAL TIMES BY HAVING TO USE MORE THAN TEN SUTURES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20778853 ↗MalfunctionDec 30, 2020Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE SUTURES BROKE NOT AT THE KNOT BUT IN THE MIDDLE OF THE STRAND. THEY OPENED ADDITIONAL SUTURES UNTIL THEY WERE ABLE TO UTILIZED ONE THAT DID NOT BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11095044 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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