Surgipro ll VP-934-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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521039667), received between Apr 19, 2019 and Apr 10, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component3
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Unintended Radiation Exposure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, NEEDLE AND THREAD BROKE ON THREE SUTURES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14069186 ↗InjuryApr 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PROCEDURE, ALL THREE REPORTED SUTURE DEVICE'S NEEDLE WERE RIPPING OFF THE SUTURE TOO EARLY AND SOMETIMES IT WAS HARD TO FIND THE NEEDLES. PATIENT HAD UNDERGONE X-RAY TO ENSURE NEEDLE WAS NOT INSIDE. SURGEON OPENED ANOTHER BOX TO RESOLVE THE ISSUE.
Patient problems: Unintended Radiation Exposure
MAUDE report 14015274 ↗MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ON A BENTALL FREESTYLE PROCEDURE, TWICE DURING RECONSTRUCTION/RESTORATION OF AORTIC CONTINUITY, THE NEEDLES DISLODGED AND FELL INTO THE PATIENT¿S THORAX. THE NEEDLES WERE RETRIEVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8533725 ↗
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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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