Surgipro II VP-734-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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521038790), received between Jan 25, 2019 and Aug 6, 2020 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 Component7
Patient problems
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS GRAFTING (CABG), THE NEEDLE DETACHED FROM THE SWAGE ON TWO SEPARATE SUTURE STRANDS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10376161 ↗MalfunctionFeb 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, 3 HOURS INTO A CORONARY BYPASS, DURING SUTURING USING THE CONTINUOUS SUTURE TECHNIQUE FOR VASCULAR ANASTOMOSIS, THE NEEDLE AND THE THREAD EASILY DISENGAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8347458 ↗MalfunctionFeb 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CORONARY BYPASS PROCEDURE, WHILE SUTURING, THE DEVICE, NEEDLE AND THREAD EASILY DISENGAGED TO EACH OTHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8306820 ↗MalfunctionFeb 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ON A CORONARY BYPASS, DURING SUTURING, THE NEEDLE AND THE THREAD OF THE TWO SUTURES USED WERE EASILY DISENGAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8300539 ↗MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS, WHEN SUTURING THE PATIENT, THE NEEDLE BROKE OFF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8298384 ↗MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS SURGERY, WHILE HANDLING THE NEEDLE, THE NEEDLE AND THREADS EASILY DISENGAGED. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT'S CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8298331 ↗MalfunctionJan 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CORONARY BYPASS PROCEDURE, THE DEVICE NEEDLE AND THREAD DISENGAGED EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8278216 ↗
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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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