Surgipro II VP706X-2Recalls & 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 non-absorbable polypropylene surgical thread used to close wounds. Most of the 34 reports describe the thread breaking during surgery, sometimes several strands at once, with a few mentioning fraying or a piece coming loose in the patient. Reports describe 6 injuries and no deaths, and there are no recalls naming 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
- 34
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521758346), received between Nov 22, 2021 and Oct 31, 2025 — classified as 6 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Break” (33 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
- Break33
- Unraveled Material4
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information18
- No Clinical Signs, Symptoms or Conditions11
- Wound Dehiscence3
- Failure to Anastomose2
- Foreign Body In Patient2
- Hematoma2
- Hemorrhage/Blood Loss/Bleeding2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE TWO SUTURES BROKE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23442848 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT DURING A CAROTID PROCEDURE, WHILE SUTURING, THE TWO SUTURES BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23442768 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628306 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628299 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628259 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628204 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628199 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628198 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628195 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628145 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628142 ↗MalfunctionJul 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE 10 SUTURES BROKE IN THE MIDDLE WHILE SUTURING. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22628140 ↗InjuryJun 13, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE NEEDLES OF THE TWO SUTURES GOT BROKEN WHILE SUTURING. THE NEEDLES FELL OFF THE PATIENT¿S CAVITY. SURGICAL TIME WAS EXTENDED BY 15 TO 20 MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 22200822 ↗InjuryJun 13, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE NEEDLES OF THE TWO SUTURES GOT BROKEN WHILE SUTURING. THE NEEDLES FELL OFF THE PATIENT¿S CAVITY. SURGICAL TIME WAS EXTENDED BY 15 TO 20 MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 22200796 ↗MalfunctionApr 24, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE DURING SUTURING, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21900567 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A VALVE REPLACEMENT, WHILE SUTURING, THE NEEDLE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19684851 ↗MalfunctionDec 29, 2023Break; Break
ACCORDING TO THE REPORTER, BOTH SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.
Patient problems: Insufficient Information
MAUDE report 18419837 ↗MalfunctionDec 29, 2023Break; Break
ACCORDING TO THE REPORTER, BOTH SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.
Patient problems: Insufficient Information
MAUDE report 18419829 ↗MalfunctionDec 19, 2023Break; Break
ACCORDING TO THE REPORTER, BOTH SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.
Patient problems: Insufficient Information
MAUDE report 18358624 ↗MalfunctionDec 19, 2023Break; Break
ACCORDING TO THE REPORTER, THE FOUR SUTURE STRANDS WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.
Patient problems: Insufficient Information
MAUDE report 18358518 ↗MalfunctionDec 19, 2023Break; Break
ACCORDING TO THE REPORTER, BOTH SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.
Patient problems: Insufficient Information
MAUDE report 18358363 ↗MalfunctionDec 19, 2023Break; Break
ACCORDING TO THE REPORTER, THE FOUR SUTURE STRANDS WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.
Patient problems: Insufficient Information
MAUDE report 18358062 ↗InjuryDec 14, 2023Break; Unraveled Material; Break; Unraveled Material
ACCORDING TO THE REPORTER, FOLLOWING A VASCULAR SURGERY, A COMPLICATION OCCURRED WHEN THREE SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES. AN OPERATION WAS CONDUCTED A WEEK LATER, REVEALING A LARGE HEMATOMA AT THE SURGICAL SITE, CONFIRMING SUTURE DEHISCENCE AS THE CAUSE, AN OCCURRENCE UNFAMILIAR TO THE SURGEON. THE PATIENT EXPERIENCED COMPLICATIONS A WEEK AFTER THE INITIAL SURGERY. FORTUNATELY, THE PATIENT WAS STILL HOSPITALIZED, PREVENTING WHAT COULD HAVE BEEN A TRAGEDY HAD THEY BEEN DISCHARGED. THE EVENT LED TO AN EXTENSION OF THE PATIENT'S HOSPITALIZATION.
Patient problems: Hematoma; Wound Dehiscence
MAUDE report 18326480 ↗InjuryDec 14, 2023Break; Unraveled Material; Break; Unraveled Material
ACCORDING TO THE REPORTER, FOLLOWING A VASCULAR SURGERY, A COMPLICATION OCCURRED WHEN THREE SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES. AN OPERATION WAS CONDUCTED A WEEK LATER, REVEALING A LARGE HEMATOMA AT THE SURGICAL SITE, CONFIRMING SUTURE DEHISCENCE AS THE CAUSE, AN OCCURRENCE UNFAMILIAR TO THE SURGEON. THE PATIENT EXPERIENCED COMPLICATIONS A WEEK AFTER THE INITIAL SURGERY. FORTUNATELY, THE PATIENT WAS STILL HOSPITALIZED, PREVENTING WHAT COULD HAVE BEEN A TRAGEDY HAD THEY BEEN DISCHARGED. THE EVENT LED TO AN EXTENSION OF THE PATIENT'S HOSPITALIZATION.
Patient problems: Hematoma; Wound Dehiscence
MAUDE report 18326446 ↗InjuryApr 27, 2023Break; Unraveled Material; Break; Unraveled Material
ACCORDING TO THE REPORTER, THE PATIENT WAS UNDERGOING CARDIAC VALVE SURGERY - ASCENDING AORTIC ANEURYSM REPAIR WITH 32 MM GEL COATED CONDUIT WITH 27 BIOPROSTHETIC CORONARY BUTTON REIMPLANTATION (RIGHT AND LEFT). WHEN THE SURGEON WAS SUTURING THE NEW VALVE IN PLACE, THERE WAS SUTURE BREAKAGE. ANOTHER SUTURE OF THE SAME KIND WAS USED BUT THE SUTURE ALSO BROKE DURING PLACEMENT. AT THE END OF THE CASE, THE SURGICAL FIELD WAS DRY. PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) IMMEDIATELY POST-OPERATIVELY. UPON ARRIVAL TO THE ICU, A LARGE AMOUNT OF BLOODY DRAINAGE WAS NOTED TO BE COMING FROM THE PATIENT¿S CHEST. THE PATIENT HAD TO BE RETURNED EMERGENTLY TO THE OPERATING ROOM FOR EXPLORATION. THE SURGEON THEN FOUND THE SUTURE HAD BROKEN AT THE LEFT CORONARY BUTTON SITE ANASTOMOSIS. THE SUTURE WAS REPLACED ENTIRELY, AND PATENCY OF THE ANASTOMOSIS SITE WAS RESTORED. APPROXIMATELY 500 ML OF BLOOD WAS ENCOUNTERED IN THE MEDIASTINUM WHEN THE PATIENT'S CHEST WAS REOPENED. HEMOGLOBIN DID NOT DROP BELOW 9.7 AND CELL SAVOR BLOOD WAS GIVEN TO THE PATIENT.
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 16828571 ↗
Other Suture, nonabsorbable, synthetic, polypropylene devices
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- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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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