Surgipro II VP-205XRecalls & 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 10884521037601), received between Jul 16, 2019 and Aug 12, 2020 — 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
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LEFT CARPAL TUNNEL OPERATION, WHILE PERFORMING CLOSURE OF THE PALMAR WOUND WITH A SUTURE, WHEN PASSING THE NEEDLE IN THE SKIN, THE NEEDLE BROKE INTO TWO. THE DISTAL 2/3 OF THE NEEDLE WAS IN THE THICKNESS OF THE SKIN'S EDGE, WHILE THE PROXIMAL 1/3 OF THE NEEDLE ATTACHED TO THE SUTURE REMAINED IN THE NEEDLE HOLDER. AFTER SEARCHING, REMOVAL OF 2/3 DISTAL OF THE BROKEN NEEDLE THAT WERE IN THE SKIN BANK WAS DONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10395041 ↗MalfunctionJul 16, 2019Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CAROTID CATHETERIZATION PLACEMENT, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8794690 ↗
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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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