Surgipro ll SP-5681Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521036857), received between Jul 14, 2020 and Aug 26, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2021Break; Break
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC GENERAL SURGERY, AT THE BEGINNING OF THE DEVICE USAGE BEFORE BEING APPLIED IN ANY TISSUE OR VESSEL, THE THREAD OF FOUR SUTURES BROKE AT THE SAME POINT REPEATEDLY MAKING IT UNABLE TO BE USED. ANOTHER DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12372853 ↗MalfunctionJul 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE THREAD BECAME LOOSE FROM THE NEEDLE WHEN IT CAME OUT OF THE PACKAGE. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10270495 ↗
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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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