Surgipro ll SP-5699GRecalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521037038), received between Jun 2, 2021 and Aug 5, 2025 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component5
- Break4
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Device Embedded In Tissue or Plaque1
- Unintended Radiation Exposure1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS ASSOCIATED WITH A BROKEN SUTURE AND A SUTURE LINE THAT DID NOT HOLD. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22716131 ↗MalfunctionAug 5, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE SUTURE WAS ASSOCIATED WITH A BROKEN SUTURE AND A SUTURE LINE THAT DID NOT HOLD. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22716064 ↗MalfunctionJun 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, OPEN PROCEDURE OF PUNCH BIOPSY WITH CLOSURE ON SCALP, THE BROKEN NEEDLE FELL INTO THE PATIENT'S CAVITY. THE SUTURE NEEDLE BROKE WHEN SUTURING AND NEEDLE HAD TO BE REMOVED FROM THE PATIENT. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 14829465 ↗InjuryMay 3, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPEN REPAIR OF LEFT THUMB LACERATION, WHEN CLOSING THE SKIN, THE NEEDLE BROKE. AN X-RAY WAS PERFORMED TO TRY LOCATING THE PIECE. THE STAFF COULD NOT FIND THE NEEDLE PIECE AND SPENT FIFTY MINUTES LOOKING. SURGICAL TIME WAS EXTENDED AS A RESULT. THE STAFF THEN CLOSED THE PATIENT AND SENT TO A DIFFERENT FACILITY FOR A HIGHER LEVEL OF CARE.
Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure
MAUDE report 14270150 ↗MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THREE SUTURES HAD NEEDLES POPPING OFF THE THREADS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14214703 ↗MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THREE SUTURES HAD NEEDLES POPPING OFF THE THREADS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14214594 ↗MalfunctionMar 9, 2022Break; Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, ALMOST THE ENTIRE BOX HAD BROKEN NEEDLE WHEN THE PHYSICIAN BEGAN TO PULL IT TIGHT TO BEGIN THE NEXT LOOP.
Patient problems: Insufficient Information
MAUDE report 13711743 ↗MalfunctionJun 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, NEEDLE POPPED OFF WHEN FIRST STARTED USING IT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11921448 ↗
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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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