Surgipro II VP-521XRecalls & 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 polypropylene suture is used to close tissue during surgery. The 42 reports mostly describe sutures detaching from needles or breaking during procedures, sometimes requiring replacement or extending surgery; some mention bleeding. There were no deaths and 4 injuries. 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
- 41
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521037786), received between Oct 23, 2017 and Sep 18, 2026 — classified as 4 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
- Break24
- Detachment of Device or Device Component22
- Adverse Event Without Identified Device or Use Problem2
- Material Frayed2
- Difficult to Remove1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information10
- No Consequences Or Impact To Patient4
- Hemorrhage/Blood Loss/Bleeding3
- No Known Impact Or Consequence To Patient3
- Failure to Anastomose2
- No Code Available2
- Tissue Damage1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break
It was reported that during a procedure, the suture thread broke. The was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819181 ↗MalfunctionJul 15, 2025Break; Break
ACCORDING TO THE REPORTER DURING A PROCEDURE, TWO SUTURES EXPERIENCED ISSUES. IT WAS NOTED THAT ONE SUTURE BROKE IN THE MIDDLE WHILE SUTURING, AND THE OTHER FAILED TO HOLD THE SUTURE LINE DURING THE PROCEDURE. AS A RESULT, THE SURGICAL TIME WAS EXTENDED TO ALLOW FOR RE-ANASTOMOSIS AND THE HEALTHCARE TEAM RESOLVED THE ISSUE BY SWITCHING TO SUTURES FROM ANOTHER MANUFACTURER.
Patient problems: Failure to Anastomose
MAUDE report 22509646 ↗MalfunctionJul 15, 2025Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER DURING A PROCEDURE, TWO SUTURES EXPERIENCED ISSUES. IT WAS NOTED THAT ONE SUTURE BROKE IN THE MIDDLE WHILE SUTURING, AND THE OTHER FAILED TO HOLD THE SUTURE LINE DURING THE PROCEDURE. AS A RESULT, THE SURGICAL TIME WAS EXTENDED TO ALLOW FOR RE-ANASTOMOSIS AND THE HEALTHCARE TEAM RESOLVED THE ISSUE BY SWITCHING TO SUTURES FROM ANOTHER MANUFACTURER.
Patient problems: Failure to Anastomose
MAUDE report 22509595 ↗MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE LUNG REPAIR SURGERY, WHEN THE DOCTOR USED THE NON-ABSORBABLE SINGLE-STRAND POLYPROPYLENE SUTURE TO REPAIR THE LUNG IN THE PATIENT'S CHEST CAVITY, THE SUTURE AT ONE END AUTOMATICALLY DETACHED FROM THE NEEDLE. THE NEEDLE WAS INITIALLY LOST, AND AFTER CAREFUL SEARCHING, THE NEEDLE WAS FOUND IN THE PATIENT'S CHEST CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112211 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20226674 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20226625 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20226606 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20226534 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20226525 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20226508 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20226499 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE EIGHT SUTURES HAD NEEDLE DETACHMENT.
Patient problems: Insufficient Information
MAUDE report 20225562 ↗MalfunctionJul 24, 2024Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THREE SUTURES WERE BROKEN IN A ROW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818135 ↗MalfunctionJul 24, 2024Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THREE SUTURES WERE BROKEN IN A ROW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817924 ↗MalfunctionJul 24, 2024Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THREE SUTURES WERE BROKEN IN A ROW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817901 ↗MalfunctionApr 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUBCOMMISURAL APPLICATION OF AORTIC VALVE, SUPRACORONARY IMPLANTATION OF GRAFT INTERPOSITUM INTERGARD 36MM, AND IMPLANTATION OF PROSTHESIS 40MM, UPON GRAFT SUTURING, THE 10 SUTURES HAD DETACHED FROM THE NEEDLE AND THE SUTURE BROKE AT ONE POINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19090911 ↗MalfunctionApr 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUBCOMMISURAL APPLICATION OF AORTIC VALVE, SUPRACORONARY IMPLANTATION OF GRAFT INTERPOSITUM INTERGARD 36MM, AND IMPLANTATION OF PROSTHESIS 40MM, UPON GRAFT SUTURING, THE 10 SUTURES HAD DETACHED FROM THE NEEDLE AND THE SUTURE BROKE AT ONE POINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19090626 ↗MalfunctionApr 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUBCOMMISURAL APPLICATION OF AORTIC VALVE, SUPRACORONARY IMPLANTATION OF GRAFT INTERPOSITUM INTERGARD 36MM, AND IMPLANTATION OF PROSTHESIS 40MM, UPON GRAFT SUTURING, THE 10 SUTURES HAD DETACHED FROM THE NEEDLE AND THE SUTURE BROKE AT ONE POINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089993 ↗MalfunctionApr 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUBCOMMISURAL APPLICATION OF AORTIC VALVE, SUPRACORONARY IMPLANTATION OF GRAFT INTERPOSITUM INTERGARD 36MM, AND IMPLANTATION OF PROSTHESIS 40MM, UPON GRAFT SUTURING, THE 10 SUTURES HAD DETACHED FROM THE NEEDLE AND THE SUTURE BROKE AT ONE POINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089802 ↗MalfunctionApr 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SUBCOMMISURAL APPLICATION OF AORTIC VALVE, SUPRACORONARY IMPLANTATION OF GRAFT INTERPOSITUM INTERGARD 36MM, AND IMPLANTATION OF PROSTHESIS 40MM, UPON GRAFT SUTURING, THE 10 SUTURES HAD DETACHED FROM THE NEEDLE AND THE SUTURE BROKE AT ONE POINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089391 ↗MalfunctionSep 6, 2023Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, IN THE ATRIUM, THE THREAD OF TWO SUTURES BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17690593 ↗MalfunctionApr 27, 2023Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN LIVER TRANSPLANTATION, WHEN COPYING SUTURE LIGATION TO STOP BLEEDING VIA INTERRUPTED SUTURE, AFTER SUTURING, THE THREAD OF THE TWO SUTURES BROKE WHEN THE KNOT WAS TIED. TO RESOLVE THE ISSUE, THE SUTURE WAS REPLACED WITH ANOTHER MODEL FROM ANOTHER COMPANY.
Patient problems: Insufficient Information
MAUDE report 16826088 ↗InjuryMar 28, 2023Break; Break
ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN PROCEDURE FOR THE INSERTION OF A PATCH AT THE ARTERIA PROFUNDA FEMORIS, THE THREAD BROKE. THERE WAS AN EMERGENCY SURGERY DUE TO THE RUPTURE OF THE PATCH SUTURE. THERE WAS A BLOOD LOSS OF MORE THAN 500CC DUE TO THE PRODUCT PROBLEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16630817 ↗MalfunctionFeb 22, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING OPEN THROMBECTOMY, AT PATCH SUTURING, THE THREAD OF THE TWO SUTURES BROKE. THE OPERATION TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE SURGERY WAS COMPLETED WITH A SUTURE FROM THE SAME LOT NUMBER. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16419026 ↗MalfunctionMar 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SURGEON WAS CLOSING THE LEFT ATRIUM DURING AN OPEN PROCEDURE, THE NEEDLE DISENGAGED FROM THE THREAD. SURGEON REPLACED THE DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13939188 ↗
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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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