Surgipro II VP-76-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 is a non-absorbable polypropylene surgical suture. Most reports describe the thread breaking during surgery or snapping on its own, sometimes even while still sealed in the package, which in a few cases lengthened the operation; a few also mention bleeding and wounds that failed to close properly. There are 50 reports, with no deaths and 6 injuries, and 44 malfunctions. No recalls name this device. Reports have dropped sharply, from 22 in the previous 12 months to 2 in the last12 months.
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
- 50
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884521039223), received between Feb 2, 2018 and Jan 27, 2026 — classified as 6 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Break” (46 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
- Break46
- Detachment of Device or Device Component5
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Material Deformation1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information5
- Failure to Anastomose4
- Hemorrhage/Blood Loss/Bleeding3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Unspecified Tissue Injury3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE 36 UNITS OF SUTURE BROKE IN THE MIDDLE WHILE SUTURING. IT WAS ALSO NOTED THAT THE PROCEDURE WAS EXTENDED BY 10 MINUTES DUE TO SUTURE BREAKAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24196391 ↗MalfunctionNov 26, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A LESION RESECTION, WHEN THE PATIENT WAS ON THE OPERATING TABLE, THE THREAD WAS AUTOMATICALLY BROKEN WITHOUT PULLING OR TENSION. A NEW PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23657341 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072725 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072542 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072480 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068629 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068598 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068582 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068559 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068465 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068403 ↗MalfunctionJan 3, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068377 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21058288 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057927 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057853 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057816 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057650 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057346 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057248 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057089 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057047 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21057018 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056803 ↗MalfunctionJan 2, 2025Break; Break
IT WAS REPORTED THAT THE SUTURE WAS FOUND BROKEN UPON OPENING THE PACKAGING PRIOR TO REMOVAL. THERE WERE 22 DEFECTIVE DEVICES INVOLVED IN THE EVENT. THE DEVICES WERE NEVER IMPLANTED. T HERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056753 ↗MalfunctionAug 5, 2024Break; Break
ACCORDING TO THE REPORTER, IN AN AUTOLOGOUS LIVER TRANSPLANTATION, WHEN A VASCULAR SUTURE WAS USED FOR VASCULAR ANASTOMOSIS, THE SUTURE BROKE. THE ISSUE CAUSED FAILURE TO THE ANASTOMOSIS. ANOTHER SUTURE WAS USED, AND RE-ANASTOMOSIS WAS DONE WHICH INCREASED THE ANHEPATIC PERIOD.
Patient problems: Failure to Anastomose
MAUDE report 19912901 ↗
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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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