Surgipro ll VP-903-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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521039575), received between Mar 15, 2018 and Aug 16, 2021 — classified as 5 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
- Break2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE KEPT ON POPPING OFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12328925 ↗MalfunctionAug 22, 2019Break; Break
ACCORDING TO THE REPORTER, WHEN SUTURING ON A CORONARY ARTERY BYPASS GRAFTING, THE THREAD BROKE. IT WAS STATED THAT THE DEVICE WAS BREAKING WITH NO FORCE. ANOTHER DEVICE FROM DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8921416 ↗MalfunctionFeb 3, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING CORONARY BYPASS, WHILE HANDLING THE NEEDLES OF 8/0 AND 7/0, THE NEEDLES AND THE THREADS EASILY DISENGAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8300529 ↗MalfunctionJan 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CORONARY BYPASS PROCEDURE, THE NEEDLES AND THREAD OF THE DEVICE WERE EASILY DISENGAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8280165 ↗MalfunctionMar 15, 2018Break; Break
ACCORDING TO THE REPORTER, THE DEVICE THREAD BROKE. THE STATUS OF THE PATIENT WAS NO PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7341695 ↗
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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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