Surgipro ll VP-70-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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521038356), received between Mar 28, 2019 and Jun 4, 2025 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Break4
- Difficult to Open or Remove Packaging Material2
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE SUTURE BROKE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. THERE WAS DIFFICULTY IN REMOVING THE SUTURE FROM THE PACKAGING, AND THE BREAK OCCURRED IN THE MIDDLE OF THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 22146896 ↗MalfunctionJun 3, 2025Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE SUTURE BROKE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. THERE WAS DIFFICULTY IN REMOVING THE SUTURE FROM THE PACKAGING, AND THE BREAK OCCURRED IN THE MIDDLE OF THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Insufficient Information
MAUDE report 22138200 ↗MalfunctionJul 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VASULAR PROCEDURE, WHILE CLOSING AN ARTERY, THE NEEDLE DETACHED FROM THE THREAD AND THE NEEDLE BROKE ON ONE SUTURE AND THE OTHER SUTURE'S THREAD BROKE. A PART OF THE SUTURE NEEDLE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITHOUT INTERVENTION. AN ALTERNATIVE PRODUCT WAS USE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14978997 ↗MalfunctionMar 28, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A HEPATECTOMY PROCEDURE, BEFORE RESECTION, THE NEEDLE WAS BROKEN. A NEW SUTURE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8461301 ↗
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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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