Surgipro II VP-743-MXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521038875), received between Jul 26, 2018 and Aug 11, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50204796 ↗
• InjuryJul 29, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN CORONARY ARTERY BYPASS GRAFTING (CABG), AT BLOOD VESSEL ANASTOMOSIS, WHEN SUTURE WAS BEING USED WITH A BULLDOG FORCEPS, THE NEEDLE DETACHED FROM THE THREAD. THE SURGERY WAS EXTENDED BY AT LEAST THIRTY MINUTES AS IT TOOK TIME TO SEARCH THE NEEDLE BUT WAS UNABLE TO FIND IT. ANOTHER SUTURE WAS USED TO CONTINUE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15132597 ↗
• InjuryApr 11, 2019Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, APPROXIMATELY 2 HOURS DURING AN OPEN-HEART SURGERY, DURING THE SUTURING OF A BIO PATCH USING A RUNNING TECHNIQUE, THE THREAD OF THE SUTURE BROKE. IT WAS NOTED THAT AFTER TESTING THE PATCH WITH ECHOCARDIOGRAM FOR A THIRD TIME, IT WAS DISCOVERED THAT THE 8-0 SUTURE LINE HAD OPENED. THE PROCEDURE WAS EXTENDED TO REDO THE SUTURE LINE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.

  Patient problems: No Code Available

  MAUDE report 8503468 ↗
• MalfunctionDec 26, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, BOTH OF THE REPORTED DEVICE HAD TROUBLE OF NEEDLE DISCONNECTION AND THREAD CUTTING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8195822 ↗
• MalfunctionJul 26, 2018Break

  ACCORDING TO THE REPORTER, WHILE USING THE DEVICE DURING A CORONARY BYPASS PROCEDURE, THE SUTURE BROKE VERY EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7721876 ↗