Surgipro ll VP-704-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
- 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 10884521038219), received between Aug 10, 2017 and Feb 24, 2022 — classified as 3 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
- Detachment of Device or Device Component1
- Dull, Blunt1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- 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.
MalfunctionFeb 24, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE PERFORMING A CONTINUOUS SUTURE, THE NEEDLE BROKE AND DETACHED FROM THE THREAD. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13593974 ↗MalfunctionJan 30, 2020Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, WHEN SUTURING THE VESSEL DURING AN OPEN BYPASS PROCEDURE, THE NEEDLE FELT HEAVY CROSSING THROUGH A VESSEL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9646925 ↗MalfunctionAug 10, 2017Break; Dull, Blunt; Break; Dull, Blunt
ACCORDING TO THE REPORTER, THE THREAD BROKE, THE SHARPNESS OF THE NEEDLE IS NOT GOOD. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6787142 ↗
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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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