Surgipro II VP-744-MXRecalls & 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
- 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 10884521038882), received between Jul 11, 2017 and Jan 31, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Detachment Of Device Component1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Code Available2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, THE THREAD BROKE IN A ROW. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN. NO PATIENT HARM REPORTED.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7232175 ↗MalfunctionJan 31, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component
ACCORDING TO THE REPORTER, DURING CORONARY BYPASS PROCEDURE, THE SUTURE BROKE IN A ROW. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINS. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7231475 ↗MalfunctionJan 31, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, THE THREAD BROKE IN A ROW. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN. NO PATIENT HARM REPORTED. THE CURRENT STATUS OF THE PATIENT IS NO PROBLEM.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7230518 ↗MalfunctionJul 11, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER THERE WAS ONLY ONE SUTURE IN THE PACKAGE AND THERE SHOULD HAVE BEEN TWO. NO PATIENT INVOLVEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6700892 ↗
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