Surgipro ll VPF-709-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521039957), received between May 28, 2019 and Oct 29, 2019 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN CAROTID ENDARTERECTOMY, TWO NEEDLES BROKE. THE FIRST WAS AT THE END OF THE PATCH HE WAS SEWING IN AND THE SECOND WAS ON AN ADDITION SUTURE BEING USED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249644 ↗
• MalfunctionOct 28, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN VASCULAR ANASTOMOSIS, WHILE TYING THE SUTURE AFTER THE ANASTOMOSIS USING A RUNNING TECHNIQUE, THE SUTURE LINE BROKE AFTER TWO THROWS IN THE KNOT. THE SURGEON USED ADDITIONAL SUTURES TO SECURE THE ANASTOMOSIS AND REINFORCED THE SUTURE LINE WITH INTERRUPTED SUTURES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9245110 ↗
• InjuryAug 14, 2019Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT HAD TO BE RE-OPERATED FOR ISCHEMIA OF THE LOWER LEFT LIMB A DAY AFTER A FEMORAL TRIPOD AND LEFT FEMOROPOPLITEAL BYPASS DUE TO HEMORRHAGE. IT WAS STATED THAT THE THREAD USED FOR THE ANASTOMOSIS OF THE VESSELS BROKE. IT WAS STATED THAT THREE DEVICES HAD THE SAME MALFUNCTION DURING THE SAME EVENT. ANOTHER SURGERY WAS DONE TO RESOLVE THE ISSUE. THE EVENT RESULTED THE PATIENT¿S EXTENDED HOSPITAL STAY. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; No Code Available

  MAUDE report 8894175 ↗
• MalfunctionMay 28, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN FEMORAL BYPASS PROCEDURE, WHILE SUTURING, ONE SUTURE HAD A NEEDLE POP OFF AND THE SECOND NEEDLE ON SAME SUTURE THE TIP BROKE. THE TWO INDIVIDUAL SUTURES BROKE WHILE SUTURING. ADDITIONAL SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8647496 ↗