Surgipro II VP-511XRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521037762), received between Jan 17, 2018 and Sep 14, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break3
Patient problems
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE.
Patient problems: Insufficient Information
MAUDE report 15419298 ↗MalfunctionMar 21, 2021Break; Break
ACCORDING TO THE REPORTER, DURING AORTIC DISSECTION, SUTURES BROKE SEVERAL TIMES. SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES TO REDO THE SUTURE.
Patient problems: Insufficient Information
MAUDE report 11536998 ↗MalfunctionJan 17, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A MITRAL VALVE REPLACEMENT AND TRICUSPID ANNULOPLASTY, WHILE CLOSING THE CARDIAC AURICLE, THE SUTURES BROKE THREE TIMES IN A ROW. WHEN THE EXTRACORPOREAL CIRCULATORY WAS STOPPED, THE SUTURE BROKE AGAIN UNDER THE EFFECT OF BLOOD PRESSURE. THEY HAD TO RESTART THE EXTRACORPOREAL CIRCULATORY AND MAKE A NEW SUTURE WITH A DEVICE FROM ANOTHER LOT. THE PROCEDURE LASTED MORE OR LESS THAN 30 MIN TO RESTART THE EXTRACORPOREAL CIRCULATORY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7200153 ↗
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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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