Surgipro II VP713X-2Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521758216), received between Mar 14, 2022 and Sep 18, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
According to the reporter, intraoperatively, upon opening the package, it was found that the suture was already broken. It was not used on the patient. Another product of the same model was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819025 ↗MalfunctionMay 5, 2025Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING THE CORONARY ARTERY BYPASS GRAFT, TWO SUTURE THREADS WERE STUCK WHEN PULLING THROUGH TISSUE WHICH PUT A RISK OF TEARING HEART TISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21964723 ↗MalfunctionMay 5, 2025Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, DURING THE CORONARY ARTERY BYPASS GRAFT, TWO SUTURE THREADS WERE STUCK WHEN PULLING THROUGH TISSUE WHICH PUT A RISK OF TEARING HEART TISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21964655 ↗MalfunctionAug 5, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 19905582 ↗InjuryMay 6, 2022Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE FEELS LARGER THAN NORMAL. IT WAS NOTED THAT THERE WAS MORE BLEEDING. TO RESOLVE THE ISSUE, THE SURGEON FINISHED USING THE SUTURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14308971 ↗MalfunctionMar 14, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A MITRAL VALVE REPAIR WITH CORONARY ARTERY BYPASS GRAFTING, WHILE SUTURING THE ANASTOMOSIS OF AORTA, THE FIRST THREAD BROKE AFTER SEVENTH THROWS WHILE THE SECOND THREAD BROKE AFTER THREE THROWS. THE SURGEON OPENED A NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13759795 ↗
Other Suture, nonabsorbable, synthetic, polypropylene devices
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- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
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- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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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