Surgipro II VP-745-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
Quick summary
This Covidien Surgipro II suture is a nonabsorbable polypropylene surgical thread used to close tissue during surgery. Reports mostly describe the thread breaking or coming apart, in some cases at the point where it meets the needle, which occasionally added extra operating time. There are 49 reports, 2 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521038905), received between Jun 8, 2018 and Mar 11, 2025 — classified as 2 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component32
- Break19
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Information3
- No Consequences Or Impact To Patient2
- Unintended Radiation Exposure2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PERIPHERAL SIDE ANASTOMOSIS IN VASCULAR BYPASS SURGERY, THE SUTURE WAS DAMAGED. THE SAME ISSUE OCCURRED ON THE OTHER TWO SUTURES. SURGICAL TIME WAS EXTENDED BY A FEW MINUTES. A NEW PRODUCT OF THE SAME LOT NUMBER WAS UNPACKED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21577033 ↗MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PERIPHERAL SIDE ANASTOMOSIS IN VASCULAR BYPASS SURGERY, THE SUTURE WAS DAMAGED. THE SAME ISSUE OCCURRED ON THE OTHER TWO SUTURES. SURGICAL TIME WAS EXTENDED BY A FEW MINUTES. A NEW PRODUCT OF THE SAME LOT NUMBER WAS UNPACKED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21577007 ↗MalfunctionMar 11, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PERIPHERAL SIDE ANASTOMOSIS IN VASCULAR BYPASS SURGERY, THE SUTURE WAS DAMAGED. THE SAME ISSUE OCCURRED ON THE OTHER TWO SUTURES. SURGICAL TIME WAS EXTENDED BY A FEW MINUTES. A NEW PRODUCT OF THE SAME LOT NUMBER WAS UNPACKED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21576966 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689666 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689645 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689640 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689438 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689424 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19689352 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686844 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686843 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686841 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686840 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686839 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686831 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686830 ↗MalfunctionJul 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686829 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19685135 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19685133 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19685131 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19685125 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19684889 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19683328 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19683069 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE 28 SUTURES WERE BROKEN AT THE CONNECTION OF THE NEEDLE AND THREAD. SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19682432 ↗
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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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