Surgipro ll VP-719-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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521038608), received between Apr 15, 2019 and Jan 29, 2020 — classified as 1 injury, 1 malfunction.
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 Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR AN ARTERIOVENOUS FISTULA, WHILE USING THE SUTURE TO CREATE A FISTULA, THE SURGEON CONTINUED TO GRAB THE SUTURE TIP WITH GRASPER TO PULL SUTURE THROUGH THICK/TOUGH TISSUE. AFTER CONTINUOUS GRABBING OF SUTURE TIP TO HELP PULL THROUGH TISSUE A SMALL PIECE OF THE NEEDLE TIP BROKE OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9644621 ↗InjuryApr 15, 2019Break; Break
ACCORDING TO THE REPORTER, 14 DAYS POST OPERATIVE FROM A CAROTID ENDARTERECTOMY, THE PATIENT CAME IN FOR AN EMERGENCY CAROTID BLOWOUT. THE SUTURE WAS BROKEN IN THE MIDDLE. IT WAS REPORTED THAT THE PATIENT WAS HAVING TROUBLE HEALING. AN EMERGENCY REPAIR TO CAROTID ARTERY WAS PERFORMED.
Patient problems: No Code Available
MAUDE report 8514514 ↗
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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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