Surgipro II VP557X-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
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521758636), received between Dec 22, 2020 and Nov 16, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment of Device or Device Component2
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions1
- Unintended Radiation Exposure1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2023Break; Break
ACCORDING TO THE REPORTER, ON A PROCEDURE, THE THREADS OF THE TWO DEVICES WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 18156912 ↗MalfunctionNov 16, 2023Break; Break
ACCORDING TO THE REPORTER, ON A PROCEDURE, THE THREAD OF THE TWO SUTURES WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 18156901 ↗InjuryApr 18, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPEN HEART SURGERY, THE TIP OF THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT. THE PART WAS RETRIEVED. ANOTHER SUTURE WAS USED TO CONTINUE THE CASE.
Patient problems: Unintended Radiation Exposure
MAUDE report 14137595 ↗MalfunctionApr 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME OFF THE SUTURE WHEN THE TECH REMOVED IT FROM THE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14059895 ↗MalfunctionDec 22, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT, A PART OF THE DEVICE BROKE. SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 11057355 ↗
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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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