Surgipro II VP-581XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521037960), received between Sep 14, 2017 and Mar 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANT, THE SUTURE BROKE TWICE DURING THE SUTURING PROCESS. THE BREAK OCCURRED IN THE MIDDLE PART OF THE SUTURE. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662816 ↗
• MalfunctionDec 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SUTURE OF THE BLOOD VESSEL USING THE DEVICE, THE THREAD BROKE NEAR THE PART WHERE THE THREAD GO THROUGH THE NEEDLE AND THE DEVICE COULD NOT BE USED. THE ANASTOMOTIC WAS COMPLETED USING A NEW PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 13043419 ↗
• MalfunctionMar 26, 2019Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, ON AN OPEN AORTIC VALVE REPLACEMENT , DURING THE SUTURING THE AORTOMY USING THE RUNNING STITCH TECHNIQUE, WHILE THE PATIENT WAS ON BYPASS, THE THREAD OF THE SUTURE BROKE. IT WAS ALSO REPORTED THAT THE SUTURE WAS FRAYING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8452121 ↗
• MalfunctionMar 14, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING MITRAL VALVE REPLACEMENT PROCEDURE, IT WAS STATED THAT THE DEVICE WAS BENDING AND THE NEEDLE BROKE. THEY USED ANOTHER DEVICE FROM SAME LOT NUMBER. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423222 ↗
• MalfunctionMar 28, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE NURSE PULLED OUT THE THREAD, IT HAD BEEN BROKEN. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7379863 ↗
• MalfunctionSep 14, 2017Difficult or Delayed Positioning; Material Protrusion/Extrusion; Difficult or Delayed Positioning; Material Protrusion/Extrusion

  ACCORDING TO THE REPORTER, WHILE UTILIZING RUNNING STITCH IN SUTURING THE AORTA WITH GRAFT MATERIAL ON AN OPEN REBUILD OF THE AORTA PROCEDURE ON (B)(6) 2017, THE NEEDLE WOULD NOT GO THROUGH GRAFT. THE DOCTOR SAID IT HAD A BURR ON IT. THEY GOT A NEW SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE AND IT WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865913 ↗