Surgipro ll VP-935-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521039674), received between Mar 6, 2018 and Jul 28, 2026 — classified as 1 injury, 5 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.

• MalfunctionJul 28, 2026Break

  According to the reporter, during a coronary artery bypass grafting procedure, during suturing, the suture broke spontaneously, which increased bleeding at the anastomotic site. It was also noted that the surgical process was delayed. The suture was replaced with a new one to resolve the issue.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50061181 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING AN OPEN CARDIOVASCULAR SURGICAL VASCULAR ANASTOMOSIS PROCEDURE, WHEN 5¿10 MINUTES INTO THE PROCEDURE, THE SUTURE THREAD BROKE. INCREASED BLEEDING WAS OBSERVED AT THE ANASTOMOTIC. THE VASCULAR ANASTOMOSIS WAS REPEATED USING A NEW SUTURE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25365779 ↗
• InjuryMar 17, 2021Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN CHEST PROCEDURE, THE SURGEON FOUND OUT THAT THE SUTURE APPLIED ON THE PATIENT HAD BROKE, THAT RESULT TO BLEEDING. TO RESOLVE THE ISSUE, THE SURGEON HAD TO RE-OPENED THE CHEST TO FIX THE BROKEN SUTURE WITH A NEW ONE. IN ADDITION WHILE CLOSING THE SKIN, THE SURGEON COULD NOT SQUEEZE THE STAPLER LEVER THAT IS WHY STAPLES NOT DEPLOY AT ALL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 11505332 ↗
• MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A BENTALL FREESTYLE PROCEDURE, TWICE DURING RECONSTRUCTION/RESTORATION OF AORTIC CONTINUITY, THE NEEDLES DISLODGED AND FELL INTO THE PATIENT¿S THORAX. THE NEEDLES WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533724 ↗
• MalfunctionJan 28, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AT THE END OF A HEART SURGERY PROCEDURE FOR THE REPLACEMENT OF AN AORTIC VALVE, THE SUTURES WERE USED TO CLOSE THE AORTOTOMY. DURING THIS PROCEDURE, THE SURGEON REPEATEDLY WITNESSED THAT THE NEEDLES/STAPLES DID NOT SEAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8281076 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIOVASCULAR PROCEDURE, WHEN USING THE SUTURE TO CLOSE A WOUND INSIDE THE CAVITY, BOTH THE DEVICES¿ NEEDLE BROKE, WHICH HAPPENED ON BOTH THE SUTURES. ANOTHER SUTURE FROM THE SAME LOT NUMBER WAS OPENED TO FINISH THE WOUND CLOSURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7317877 ↗