Surgipro ll VP-702-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
- 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 10884521038134), received between Sep 7, 2017 and Dec 11, 2019 — 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
- Material Frayed2
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE NEEDLE OF THE SUTURE BROKE. IT WAS REPORTED THAT ANOTHER SUTURE HAD THREAD BROKEN WHEN TYING THE KNOT AND LASTLY A THIRD SUTURE HAD NEEDLE DETACHED WHEN IT SHOULD NOT.
Patient problems: No Information
MAUDE report 9450193 ↗MalfunctionSep 22, 2017Break; Material Frayed; Break; Material Frayed
ACCORDING TO THE REPORTER, OCCURRED DURING AN OPEN CORONARY ARTERY BYPASS GRAFT, CABG PROCEDURE. WHILE SUTURING THE DISTAL ANASTOMOSIS, THE SUTURE FRAYED. WHEN ON PUMP, ANOTHER SUTURE BROKE. THE SUTURE IS TREATED OR HYDRATED BY SQUIRTING WATER ON THE SUTURE AND SURGEON'S HANDS. TO COMPLETE THE CASE, ANOTHER SUTURE WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6886751 ↗MalfunctionSep 7, 2017Break; Material Frayed; Break; Material Frayed
ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN CORONARY ARTERY BYPASS GRAFT, CABG PROCEDURE. WHILE SUTURING THE DISTAL ANASTOMOSIS, THE SUTURE FRAYED. WHEN ON PUMP, ANOTHER SUTURE BROKE. THE SUTURE IS TREATED OR HYDRATED BY SQUIRTING WATER ON THE SUTURE AND SURGEON'S HANDS. TO COMPLETE THE CASE, ANOTHER SUTURE WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6849347 ↗
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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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