Surgipro ll VPF-807-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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521040069), received between Apr 19, 2017 and Jan 13, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2023Break; Break
ACCORDING TO THE REPORTER, THE NEEDLES BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16157652 ↗MalfunctionJan 13, 2023Break; Break
ACCORDING TO THE REPORTER, THE NEEDLES BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16157574 ↗MalfunctionMar 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A HEMODYNAMICS PROCEDURE, ALL THREE SUTURES HAD NEEDLE BROKEN. A NEW SUTURE WAS USED WITH NO PROBLEM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13890242 ↗InjuryApr 19, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component
ACCORDING TO THE REPORTER: PER ADDITIONAL INFORMATION RECEIVED, THE SUTURE WAS HYDRATED PRIOR TO USE. A CONTINUES STITCH WAS EMPLOYED BY THE SURGEON. THE CURRENT PATIENT STATUS IS HEALTHY AND CURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6503421 ↗
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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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