Surgipro ll VP-902-MXRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521039551), received between Jan 22, 2019 and Nov 15, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2021Break; Break
ACCORDING TO THE REPORTER, DURING A THORACOTOMY CORONARY ARTERY BYPASS SURGERY, WHILE ON ANASTOMOSIS OF THE DISTAL SIDE, THE THREAD BREAKAGE OCCURRED DURING SUTURE. THE REMAINING PART WAS SUTURED AGAIN TO RESOLVE THE CONCERN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12817605 ↗MalfunctionJan 22, 2019Break; Break
ACCORDING TO THE REPORTER, WHILE USING THE PRODUCT FOR ANASTOMOSIS ON A CORONARY BYPASS, THE THREAD BROKE WHEN THE SURGEON TIED THE THREAD. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8269527 ↗
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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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