Surgipro II VP-580XRecalls & 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 10884521037953), received between Feb 21, 2020 and Jun 25, 2020 — 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2020Break; Break
ACCORDING TO THE REPORTER, WHEN THE SURGEON USED THE DEVICE WITH THE PUSHER TO GO DOWN ON A LAPAROSCOPIC REPLACEMENT VALVE OF A MITRAL PLASTY PROCEDURE, THE THREAD OF THE DEVICE BROKE. SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO INCREASE TIME OF THE DEVICE FOR EXTRA-CORPORAL CIRCULATION. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10197058 ↗MalfunctionFeb 21, 2020Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN ARTERIOVENOUS FISTULA PROCEDURE, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9739237 ↗
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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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