Surgipro ll SP-5697GRecalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521036987), received between Apr 9, 2021 and Oct 4, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2023Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN TYING A KNOT, THE THREAD OF ONE SUTURE BROKE. THEN ANOTHER SUTURE FROM THE SAME PACK BROKE ON ANOTHER SPOT OF THE THREAD AS THE SURGEON WAS TYING ANOTHER KNOT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17873997 ↗MalfunctionOct 4, 2023Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN TYING A KNOT, THE THREAD OF ONE SUTURE BROKE. THEN ANOTHER SUTURE FROM THE SAME PACK BROKE ON ANOTHER SPOT OF THE THREAD AS THE SURGEON WAS TYING ANOTHER KNOT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17873996 ↗MalfunctionOct 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, IN AN OPEN PROCEDURE, ONE NEEDLE FELL OFF THE SUTURE WHILE GRASPING NEEDLE WITH A NEEDLE DRIVER OUTSIDE OF THE PATIENT'S TISSUE. THE NEXT PACKS OF SUTURE WAS USED NORMALLY; HOWEVER, THE THREAD OF ANOTHER TYPE OF SUTURE BROKE. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17857405 ↗MalfunctionSep 1, 2023Break; Break
ACCORDING TO THE REPORTER, THE SUTURE MATERIAL BROKE ABOUT 1 INCH ABOVE THE NEEDLE.
Patient problems: Insufficient Information
MAUDE report 17673851 ↗MalfunctionAug 8, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A SKIN CANCER PROCEDURE, THE SUTURE MATERIAL BROKE ABOUT ONE INCH ABOVE THE NEEDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE, THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17483726 ↗MalfunctionApr 9, 2021Break; Break
ACCORDING TO THE REPORTER, DURING A TENDON REPAIR PROCEDURE, THE SUTURE BROKE WHILE BEING TIED DOWN TO MAKE A KNOT. AN ADDITIONAL SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11642434 ↗
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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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