Surgipro ll SP-5698Recalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro ll (70)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521036994), received between Aug 24, 2017 and Apr 11, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break8
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE THREADS OF THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089562 ↗MalfunctionApr 11, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE THREADS OF THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089536 ↗MalfunctionApr 11, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREE THREADS OF THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089501 ↗MalfunctionOct 23, 2020Break; Break
ACCORDING TO THE REPORTER, DURING MAXILLOFACIAL SURGERY, AT THE TIME OF WOUND CLOSURE, 2 THREADS BROKE EASILY. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10729735 ↗MalfunctionMar 13, 2020Break; Break
ACCORDING TO THE REPORTER, DURING INTERNAL AND EXTERNAL COMMON CAROTID ENDARTERECTOMY, AT THE TIME OF PASSING THE SUTURE POINT, THE FIRST THREAD BROKE. AT THE TIME OF CLOSING THE ARTERIOTOMY OF THE SHORT ENDORECTOMY, THE THREAD BROKE BY HALF WITHOUT EXECUTING ANY PRESSURE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9829821 ↗MalfunctionNov 28, 2018Break; Break
ACCORDING TO THE REPORTER DURING A ORAL SURGERY, 90 MINUTES AFTER THE START OF THE PROCEDURE, WHEN SUTURING THE SKIN USING A SINGLE KNOT, THE NEEDLE AND THE SUTURE BROKE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8112137 ↗MalfunctionDec 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SCLEROTHERAPY OF VARICOSE VEINS PROCEDURE, ONE HOUR OF PROCEDURE, THE DEVICE'S NEEDLE AND THREAD WAS BROKEN. IN THE FIRST POINT OF THE SUTURE THE NEEDLE WAS DISASSEMBLED FROM THE THREAD. THE SUTURE WAS TREATED/HYDRATED WITH SERUM PRIOR TO USE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7088028 ↗MalfunctionOct 9, 2017Break; Break
ACCORDING TO THE REPORTER, DURING A NOSE JOB PROCEDURE, THE SUTURE BROKE 30 MINUTES INTO THE PROCEDURE WHEN IT WAS SUTURED TO PASS THE FIRST STITCH. A NEW DIFFERENT SUTURE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6931784 ↗MalfunctionAug 24, 2017Break; Break
ACCORDING TO THE REPORTER, ON (B)(6) 2017, PRE-OPERATIVELY, THE DEVICE BROKE, THERE WAS A DAMAGE AT THE LEVEL OF THE EYE OF THE NEEDLE. NO PATIENT INVOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6816770 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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