Surgipro ll VP-712-MXRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521038400), received between Aug 22, 2019 and Aug 27, 2019 — 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
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2019Break; Break
ACCORDING TO THE REPORTER, ON A FONTAN PROCEDURE, USING THE RUNNING STITCH TECHNIQUE, 2 NEEDLES BROKE WHILE ATTEMPTING TO SUTURE A MESH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8936390 ↗MalfunctionAug 22, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
ACCORDING TO THE REPORTER, UPON SUTURING THE DARCON POUCH ON AN OPEN VENTRICULAR SEPTAL DEFECT AND RELIEF OF VENTRICULAR OUTFLOW TRACK OBSTRUCTION, THE NEEDLE BROKE. IT WAS ALSO STATED THAT THE NEEDLE BENT. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8921370 ↗
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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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