Surgipro II VP-78-XRecalls & 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 10884521039278), received between Feb 1, 2021 and Apr 2, 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 Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2021Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CONTINUOUS VASCULAR ANASTOMOSIS, AT THE END OF THE SUTURING, THE THREAD BROKE. SEVERAL STITCHING'S WERE MADE WITH 2 DIFFERENT TYPES OF SUTURES TO RESOLVE THE ISSUE. THE OPERATING TIME INCREASED BY 15 MINUTES. THERE WAS ALSO BLOOD LOSS OF UNSPECIFIED AMOUNT. THERE WAS NO PATIENT INJURY.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 11606752 ↗MalfunctionFeb 1, 2021Break; Break
ACCORDING TO THE REPORTER, DURING OPEN VASCULAR ANASTOMOSIS, UPON KNOTTING OF THREAD AFTER THE VASCULAR ANASTOMOSIS, THE THREAD BROKE. THE VESSEL WAS COMPLETELY RE-SEWN AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11257691 ↗
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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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