Surgipro II VP701X-2Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521758193), received between Sep 8, 2021 and Aug 8, 2024 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A SHUNT PROCEDURE, THE WHEN THE DEVICE WAS USED AS USUAL WITH NORMAL FORCE, THE THREAD BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19941113 ↗MalfunctionNov 4, 2022Break; Break
ACCORDING TO THE REPORTER, DURING SURGERY, TWO SUTURES FROM DIFFERENT MODELS WERE BREAKING.
Patient problems: Insufficient Information
MAUDE report 15739500 ↗MalfunctionApr 12, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAPH PROCEDURE, AT THE BEGINNING OF THE ANASTOMOSIS, THE THREAD BROKE. ANOTHER STRAND WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14087958 ↗MalfunctionSep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER PREOPERATIVELY, THE NEEDLE POPPED OFF WHILE BEING PULLED OUT OF THE PACKAGE. ANOTHER SUTURE WAS USED IN ORDER TO COMPLETE THE CASE. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 12440100 ↗
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- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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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