Surgipro ll VP-703-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521038189), received between May 23, 2018 and Aug 12, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2021Break; Break

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC AV FISTULA GRAFT, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314327 ↗
• MalfunctionFeb 13, 2020Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE, WHILE SEWING THE VESSEL, WHEN THE SURGEON PULLED THE STITCH THROUGH, THE THREAD STRETCHED AND SNAPPED. IT WAS NOTED THAT THE STRAND FRAYED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707644 ↗
• MalfunctionSep 29, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY, THE THREADS BROKE ON 5 SUTURES. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9132593 ↗
• MalfunctionJun 11, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN FEMORAL ENDOVASCULAR PROCEDURE, THE DEVICE NEEDLE BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687298 ↗
• MalfunctionMar 18, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CAROTID VASCULAR PROCEDURE, THE NEEDLE'S TIP BROKE. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8427951 ↗
• 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 8423120 ↗
• MalfunctionFeb 18, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ARTERIOVENOUS FISTULA PROCDURE, WHEN SUTURING, THE THREAD BROKE. THEY OPENED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348642 ↗
• MalfunctionFeb 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A VASCULAR ACCESS FISTULA PROCEDURE, THE NEEDLE TIP BROKE ONCE THE TECHNICIAN RECEIVED THE SUTURE FROM THE SURGEON ON THE FIELD, THIS WAS ON TOP OF THE MAYO STAND AND WAS NOT DISENGAGED TO THE PATIENT. THE ISSUE OCCURRED AFTER THE PROCEDURE, AND IS NO LONGER NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8342919 ↗
• MalfunctionDec 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN REMOVING THE SUTURE FROM THE PACKAGING, THE NEEDLE DETACHED FROM THE STRAND. IT WAS REPORTED ANOTHER SUTURE WAS USED TO RESOLVED THE ISSUE AND COMPLETED THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8203972 ↗
• MalfunctionMay 23, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ANASTOMOSIS, THE NEEDLE DETACHED FROM THE STRAND AND THE SURGICAL TIME EXTENDED FOR THIRTY MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. NEW SUTURES HAD TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7537516 ↗