Surgipro II VP-728-XRecalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro II (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521038714), received between Jul 30, 2018 and Jan 28, 2021 — classified as 3 injuries, 3 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.
Most reported problems
Device problems
- Break5
- Detachment of Device or Device Component1
Patient problems
- No Code Available2
- No Known Impact Or Consequence To Patient2
- Blood Loss1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN AORTO FEMORAL BYPASS, WHEN SUTURING THE FEMORAL ARTERY, THE THREAD BROKE OFF THE NEEDLE. USED ANOTHER DEVICE FROM DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11242992 ↗InjuryJun 26, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE NEEDLE WAS GOING THROUGH THE CAROTID ARTERY, THE NEEDLE BROKE. THE PATIENT WAS HOSPITALIZED.
Patient problems: No Code Available
MAUDE report 8733273 ↗InjuryJun 26, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE NEEDLE WAS GOING THROUGH THE CAROTID ARTERY, THE NEEDLE BROKE. THE PATIENT WAS HOSPITALIZED.
Patient problems: No Code Available
MAUDE report 8733270 ↗MalfunctionJan 17, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A BYPASS PROCEDURE, THE THREAD AND THE NEEDLE BROKE. THEY CHANGED SUTURE AND SUTURED AGAIN. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8258858 ↗InjuryNov 2, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS, AFTER THE ANASTOMOSIS, WHILE DOING A CONTINUOUS STITCH ON DESCENDING AORTA, THE SUTURE BROKE AT THE STRAND (ABOVE THE KNOT) AND CAUSED MASSIVE BLEEDING. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PROBLEM. THEY IMMEDIATELY DRESSED THE WOUND. THEY USED SAME DEVICE FROM THE SAME LOT TO COMPLETE THE CASE.
Patient problems: Blood Loss
MAUDE report 8032552 ↗MalfunctionJul 30, 2018Break
ACCORDING TO THE REPORTER, DURING A CAROTID ARTERY SURGERY, WHILE THEY WERE SUTURING THE PATCH ON THE VESSEL USING A CONTINUOUS SEWING TECHNIQUE, THE MIDDLE PART OF NEEDLE BROKE. THIS HAPPENED TWO TIMES, THEN THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7731670 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page