Surgipro II VP-510XRecalls & 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 10884521037755), received between Dec 11, 2019 and Dec 15, 2021 — 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 Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2021Break; Break
ACCORDING TO THE REPORTER, DURING OPEN DOUBLE MITRO AORTIC REPLACEMENT, WHEN SUTURING VALVE, THREAD BROKE THRICE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13009569 ↗MalfunctionDec 11, 2019Break; Break
ACCORDING TO THE REPORTER, WHEN USING THE EXTRACORPOREAL CIRCULATION DURING AN OPEN PROCEDURE FOR MYXOMA AT THE LEFT ATRIUM, THE SUTURE WAS BROKEN THREE TIMES DURING A SUTURE IN THE VENA CAVA. ANOTHER SUTURES WAS USED TO COMPLETE THE CASE.
Patient problems: No Information
MAUDE report 9450604 ↗
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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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