Surgipro II VP-522XRecalls & 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 VP-522X is a non-absorbable polypropylene surgical suture used to close wounds. The 28 reports mostly describe the suture or needle breaking or coming apart mid-procedure, sometimes fraying, which in a few cases meant extra bleeding and longer surgery. There is 1 death and 1 injury among the reports. 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
- 27
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521037793), received between Jan 19, 2018 and Feb 24, 2026 — classified as 1 death, 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Break” (19 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
- Break19
- Detachment of Device or Device Component15
- Material Frayed2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient6
- Hemorrhage/Blood Loss/Bleeding3
- Blood Loss1
- Death1
- Exsanguination1
- Insufficient Information1
- Multiple Organ Dysfunction Syndrome1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE USING THE SUTURE TO CLOSE THE PATIENT'S WOUND, THE SUTURE TAIL DETACHED FROM THE NEEDLE TAIL. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434704 ↗MalfunctionFeb 20, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A RIGHT HEPATECTOMY WITH SEVERE LIVER TRAUMA AND A RUPTURED RIGHT LOBE, THE NEEDLE WAS BENT ON THE FIRST ATTEMPT AT INSERTION, REQUIRING GREATER FORCE THAN USUAL, WHICH GENERATED TECHNICAL DIFFICULTY. IT WAS NOTED THAT TWO SUTURES WERE USED AND HAD THE SAME ISSUE. ANOTHER TWO SUTURES WERE USED BUT THE NEEDLE DETACHED FROM THE THREAD.
Patient problems: Insufficient Information
MAUDE report 24404519 ↗MalfunctionOct 16, 2025Break; Break
IT WAS REPORTED THAT DURING AN OPEN PROCEDURE FOR RIGHT FOOT IRRIGATION AND DEBRIDEMENT WITH BONE BIOPSY, WHILE CLOSING, TWO NEEDLES BROKE AND ONE SUTURE STRAND BROKE IN THE MIDDLE, ALL WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23307274 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT DURING AN OPEN PROCEDURE FOR RIGHT FOOT IRRIGATION AND DEBRIDEMENT WITH BONE BIOPSY, WHILE CLOSING, TWO NEEDLES BROKE AND ONE SUTURE STRAND BROKE IN THE MIDDLE, ALL WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299485 ↗MalfunctionOct 15, 2025Break; Break
IT WAS REPORTED THAT DURING AN OPEN PROCEDURE FOR RIGHT FOOT IRRIGATION AND DEBRIDEMENT WITH BONE BIOPSY, WHILE CLOSING, TWO NEEDLES BROKE AND ONE SUTURE STRAND BROKE IN THE MIDDLE, ALL WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23299362 ↗MalfunctionSep 17, 2025Break; Break
IT WAS REPORTED THAT DURING ABDOMINAL AORTIC ANEURYSM SURGERY AND ENDOVALVE REPAIR, WHILE SUTURING WITH THE POLYPROPYLENE MONOFILAMENT, THE SUTURES BROKE IN THE MIDDLE AND SUTURE INTEGRITY WAS LOST. THIS RESULTED IN THE NEED FOR RESUTURING, GREATER THAN NORMAL INTRAOPERATIVE BLEEDING AND AN EXTENSION OF THE SURGICAL PROCEDURE BY 20 MINUTES. IT WAS REPORTED THAT THREE SUTURES FROM THE SAME PRODUCT AND LOT WAS INVOLVED AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23073453 ↗MalfunctionSep 17, 2025Break; Break
IT WAS REPORTED THAT DURING ABDOMINAL AORTIC ANEURYSM SURGERY AND ENDOVALVE REPAIR, WHILE SUTURING WITH THE POLYPROPYLENE MONOFILAMENT, THE SUTURES BROKE IN THE MIDDLE AND SUTURE INTEGRITY WAS LOST. THIS RESULTED IN THE NEED FOR RESUTURING, GREATER THAN NORMAL INTRAOPERATIVE BLEEDING AND AN EXTENSION OF THE SURGICAL PROCEDURE BY 20 MINUTES. IT WAS REPORTED THAT THREE SUTURES FROM THE SAME PRODUCT AND LOT WAS INVOLVED AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23073406 ↗MalfunctionSep 17, 2025Break; Break
IT WAS REPORTED THAT DURING ABDOMINAL AORTIC ANEURYSM SURGERY AND ENDOVALVE REPAIR, WHILE SUTURING WITH THE POLYPROPYLENE MONOFILAMENT, THE SUTURES BROKE IN THE MIDDLE AND SUTURE INTEGRITY WAS LOST. THIS RESULTED IN THE NEED FOR RESUTURING, GREATER THAN NORMAL INTRAOPERATIVE BLEEDING AND AN EXTENSION OF THE SURGICAL PROCEDURE BY 20 MINUTES. IT WAS REPORTED THAT THREE SUTURES FROM THE SAME PRODUCT AND LOT WAS INVOLVED AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23073352 ↗MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, UPON OPENING THE PACKAGING PRIOR TO REMOVAL, THE TWO SETS OF SUTURES BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20176177 ↗MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, UPON OPENING THE PACKAGING PRIOR TO REMOVAL, THE TWO SETS OF SUTURES BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20175413 ↗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 19089675 ↗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 19089608 ↗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 19089564 ↗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 19089483 ↗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 19089253 ↗MalfunctionOct 2, 2023Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN CARDIAC SURGERY, WHEN AT THE VESSEL PERIPHERICAL IN CARDIAC SPACE, WHEN THE KNOT WAS GOING TO BE TIED AS A SINGLE KNOT, IT UNRAVELED AND THE THREAD CAME OFF THE NEEDLE AT THE JUNCTION POINT. ANOTHER SUTURE WITH A DIFFERENT LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17852333 ↗MalfunctionDec 30, 2020Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE SUTURES BROKE NOT AT THE KNOT BUT IN THE MIDDLE OF THE STRAND. THEY OPENED ADDITIONAL SUTURES UNTIL THEY WERE ABLE TO UTILIZED ONE THAT DID NOT BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11096198 ↗MalfunctionOct 1, 2020Break; Material Frayed; Break; Material Frayed
ACCORDING TO THE REPORTER, PRIOR TO THE PROCEDURE, WHEN THE TECH WAS PUTTING THE SUTURE ON A PLEDGET, THE SUTURE SNAPPED AND SHREDDED. ADDITIONAL SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10617289 ↗MalfunctionAug 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPY ASSISTED DISTAL GASTRECTOMY, AT THE TIME OF CLOSING THE COMMON STOMA, THE THREAD BROKE AND THE NEEDLE FELL INTO THE BODY. THE NEEDLE THAT WAS BROKE FROM THE GRIP PART OF THE THREAD WAS COLLECTED IMMEDIATELY BY DIRECT VIEWING. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10400373 ↗MalfunctionSep 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE NEEDLE DISINTEGRATED FROM THE THREAD. THE NEEDLE WAS RECOVERED FROM THE TROCAR, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9118535 ↗InjuryJul 1, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROINTESTINAL SURGERY, THE NEEDLE WAS RELEASED AND FALL INTO THE PATIENT'S CAVITY WHEN THEY WERE TAKING OUT THE SUTURE INTO THE TROCAR. AN X-RAY WAS DONE TO LOCATE THE DEVICE AND FOUND OUT IT WAS LOCATED CLOSE TO THE ARM. SURGICAL TIME WAS EXTENDED MORE THAN THIRTY MINUTES DUE TO THE PRODUCT PROBLEM.
Patient problems: No Code Available; Radiation Exposure, Unintended
MAUDE report 8751165 ↗MalfunctionMay 6, 2019Break; Break
ACCORDING TO THE REPORTER DURING A MITRAL VALVE REPLACEMENT, WHEN CLOSING THE ATRIUM, TEN MINUTES INTO THE PROCEDURE, WHILE THE SURGEON WAS KNOTTING, THE THREAD OF BOTH THE DEVICE BROKE. THE SUTURE WAS NOT HYDRATED PRIOR TO USE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8584852 ↗MalfunctionMay 6, 2019Break; Break
ACCORDING TO THE REPORTER DURING A MITRAL VALVE REPLACEMENT, WHEN CLOSING THE ATRIUM, TEN MINUTES INTO THE PROCEDURE, WHILE THE SURGEON WAS KNOTTING, THE THREAD OF BOTH THE DEVICE BROKE. THE SUTURE WAS NOT HYDRATED PRIOR TO USE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8584844 ↗MalfunctionMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN SUTURING THE VESSEL DURING AN ILIAC FEMORAL POPLITEAL THROMBOENDARTERECTOMY PROCEDURE, THE NEEDLE BROKE AT SWAGE. THEY USED ANOTHER SUTURE PACK TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8422630 ↗MalfunctionFeb 25, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, AFTER A RIGHT HEPATIC ALVEOLAR RESECTION WAS PERFORMED TO SUTURE THE HEMOSTASIS, THE NEEDLE WAS REMOVED AND THE TIP WAS FOUND TO BE DAMAGED ABOUT 0.5 MM. IMMEDIATELY, THE DOCTOR SEARCHED AND AGREED TO CLOSE THE BODY CAVITY. NO X-RAY EXAMINATION WAS CONDUCTED ON THE PATIENT AFTER THE OPERATION. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8368136 ↗
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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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