Surgipro ll VP-842-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 10884521039377), received between Jul 18, 2019 and May 30, 2025 — classified as 1 injury, 2 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
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2025Break; Break
IT WAS REPORTED THAT DURING THE USE OF SUTURES TO ANASTOMOSE AN AORTIC GRAFT, THE TIP OF THE NEEDLE BROKE AWAY FROM THE NEEDLE WHILE SUTURING. THE NEEDLE TIP COULD NOT BE RETRIEVED FROM THE PATIENT, AND THE SURGEON DEEMED IT UNSAFE TO ATTEMPT LOCATING THE TIP. THE AREA BEING SUTURED WAS HEAVILY CALCIFIED, AND THE NEEDLE TIP HAD BEEN PICKED UP BY THE NEEDLE HOLDER. ADDITIONALLY, TWO FURTHER NEEDLES USED IN THE SAME CASE DETACHED AT THE SWAGE. IT WAS NOTED THAT THE PATIENT DIED DUE TO A CARDIAC ARREST.
Patient problems: Foreign Body In Patient
MAUDE report 22114489 ↗MalfunctionJun 21, 2023Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, TWO HOURS INTO THE PROCEDURE, WHILE EMPLOYING THE RUNNING STITCH TECHNIQUE DURING INFRA-RENAL AORTA REPAIR, THE THREAD BROKE. NO DEVICE COMPONENT FELL INTO THE CAVITY. REPAIR STITCH WAS REQUIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17171313 ↗MalfunctionJul 18, 2019Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN AORTO BILATERAL FEMORAL BYPASS PROCEDURE, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8802818 ↗
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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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