Surgipro ll SP-5695GRecalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521036970), received between Dec 1, 2019 and May 25, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE DOCTOR WAS PREPARING FOR DEBRIDEMENT AND SUTURE, AND WHEN FIRST SUTURE JUST STARTED, THE SUTURE NEEDLE WAS BROKEN. THE PART THAT ENTERED THE TISSUE WAS CLIPPED OUT BY THE DOCTOR IN TIME, WITHOUT CAUSING ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14499540 ↗MalfunctionMay 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A MICROGRAPHICALLY ORIENTED HISTOGRAPHIC SURGERY, WHILE ON THE LEFT FOREHEAD FOR CUTANEOUS SUTURES, THE NEEDLE DETACHED FROM THE THREAD. THE SUTURE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14409265 ↗MalfunctionApr 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A SCAR REMOVAL VIA OPEN PROCEDURE WHILE SUTURING WOUND USING THE CONTINUOUS OR INTERMITTENT TECHNIQUE, BOTH THE NEEDLE AND THREAD BROKE AND DETACHED. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14118474 ↗MalfunctionDec 1, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, IN THE KNOTTING PROCESS, THE SUTURE AUTOMATICALLY BROKE OFF AT THE POSITION 6CM AWAY FROM THE END WITHOUT TOUCHING THE END. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9392757 ↗
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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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