Surgipro ll SP-5682GRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521036888), received between Oct 18, 2017 and Oct 29, 2020 — classified as 3 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.
Most reported problems
Device problems
- Break3
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE. A SUTURE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10754171 ↗MalfunctionJun 22, 2018Break; Break
ACCORDING TO THE REPORTER: THE SUTURE MATERIAL SNAPPED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7631699 ↗MalfunctionOct 18, 2017Break; Break
ACCORDING TO THE REPORTER, POST OPERATIVELY, THE DEVICE¿S THREAD BROKE WHILE BEING USED FOR SKIN CLOSURE. THE PHYSICIAN HAD TROUBLE WITH THE DEVICE. THERE WILL BE AN ADDITIONAL OPERATION PERFORMED TO CORRECT THE ISSUE. NEW DEVICE WAS USED TO COMPLETE THE CASE. PATIENT STATUS AND OUTCOME WERE UNKNOWN.
Patient problems: No Code Available
MAUDE report 6959718 ↗
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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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