Surgipro ll VP-914-XRecalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro ll (70)
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 10884521039629), received between Mar 6, 2018 and Jan 19, 2022 — 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
- Blood Loss1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE. THE SURGEON USED A NEW SUTURE TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 13289447 ↗MalfunctionMar 6, 2018Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN HEART TRANSPLANT PROCEDURE, WHILE BEING APPLIED FOR SUTURING, THE DEVICE¿S NEEDLE BROKE. AS A RESULT, PATIENT HAD A BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE.
Patient problems: Blood Loss
MAUDE report 7318262 ↗
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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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