Surgipro II VP709X-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521758278), received between Mar 24, 2023 and Aug 18, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50309203 ↗
• MalfunctionNov 19, 2025Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING IN A FEMORAL PATCH, THE SURGEON NOTICED THAT THERE WAS MORE BLEEDING AND USED A HEMOSTATIC AGENT TO STOP THE BLEEDING WHEN SUTURING. IT WAS NOTED THAT THE END WHERE THE NEEDLE CAME OUT WAS CATCHING OR LARGER THAN THE OPENING THAT THE NEEDLE MADE INITIALLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23591050 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL ARTERIALIZATION (AV FISTULA) PROCEDURE INVOLVING THE SUTURE CHECK VALVE, THE SUTURE BROKE MULTIPLE TIMES WHILE SUTURING, SPECIFICALLY IN THE MIDDLE. THE ISSUE OCCURRED WITH MORE THAN ONE DEVICE, ALL FROM THE SAME PRODUCT ID AND LOT NUMBER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. NO PATIENT COMPLICATIONS HAD BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929739 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL ARTERIALIZATION (AV FISTULA) PROCEDURE INVOLVING THE SUTURE CHECK VALVE, THE SUTURE BROKE MULTIPLE TIMES WHILE SUTURING, SPECIFICALLY IN THE MIDDLE. THE ISSUE OCCURRED WITH MORE THAN ONE DEVICE, ALL FROM THE SAME PRODUCT ID AND LOT NUMBER. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. NO PATIENT COMPLICATIONS HAD BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912553 ↗
• MalfunctionMay 6, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE.

  Patient problems: Insufficient Information

  MAUDE report 19249888 ↗
• MalfunctionNov 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR VENOUS LEFT LOWER POPLITEAL FEMORAL BYPASS, THE SUTURE BROKE SPONTANEOUSLY WHEN PERFORMING A ARTERIAL SUTURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS BLOOD LOSS OF LESS THAN 500CC. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES DUE TO THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18184475 ↗
• MalfunctionJun 21, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LEFT UPPER EXTREMITY FOREARM LOOP GRAFT, WHEN REPAIRING THE HOLE IN THE VESSEL, THE THREAD OF THE DEVICE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17177673 ↗
• InjuryMar 24, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LOWER EXTREMITY BYPASS, THE SURGEON STATED THAT THE NEEDLES BROKE INTO PIECES. A NEW SUTURE HAD TO BE OBTAINED TO SEW THE ANASTOMOSIS AND THE ISSUE WAS RESOLVED. IT WAS NOTED THAT SURGICAL TIME EXTENDED BUT DID NOT EXCEED 30 MINUTES OF ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 16616069 ↗