Surgipro II VP720X-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521758452), received between Jun 27, 2022 and Dec 28, 2023 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A THORACOTOMY FOR MITRAL VALVE REPLACEMENT, AT THE TIME OF LIGATION, THE SUTURE BROKE. IT OCCURRED ON THREE SUTURES. THE SAME PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414418 ↗
• MalfunctionDec 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A THORACOTOMY FOR MITRAL VALVE REPLACEMENT, AT THE TIME OF LIGATION, THE SUTURE BROKE. IT OCCURRED ON THREE SUTURES. THE SAME PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411409 ↗
• MalfunctionJan 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A BYPASS ON INCUBATOR VESSELS ILIAC AND VISCERAL ILIOFEMORAL ARTERIES, WHEN ANASTOMOSIS SUTURING WAS PERFORMED THE NEEDLE BROKE. THE SURGEON TOOK ANOTHER SUTURE FROM THE SAME LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271045 ↗
• MalfunctionJan 31, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ENDARTERECTOMY, WHEN CREATING A BYPASS AT BREEDING VESSELS FEMORAL ARTERY, WHEN ANASTOMOSIS SUTURING WAS PERFORMED, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE TIPS WERE PICKED UP. THE SURGEON TOOK ANOTHER SUTURE FROM THE SAME LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. THE PROBLEM HAS OCCURRED MORE FREQUENTLY IN RECENT MONTHS. SEVERAL NEEDLES HAVE BROKEN OFF AGAIN AND AGAIN IN VARIOUS PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16270919 ↗
• MalfunctionJan 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN ENDARTERECTOMY ARTERIAL FEMORAL ARTERY, WHEN ANASTOMOSIS SUTURING WAS PERFORMED THE NEEDLE BROKE. THE SURGEON TOOK ANOTHER SUTURE FROM THE SAME LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258561 ↗
• MalfunctionJan 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN ENDARTERIECTOMIE ABDOMINAL AND PELVIS A. ILIAC COMMUNIS, WHEN ANASTOMOSIS SUTURING WAS PERFORMED THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258505 ↗
• MalfunctionJan 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A SHUNT AND BYPASS A. ILIAC AND A. ILIOFEMORAL PROCEDURE, WHEN ANASTOMOSIS SUTURING WAS PERFORMED THE NEEDLE BROKE. THE SURGEON TOOK ANOTHER SUTURE FROM THE SAME LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252832 ↗
• MalfunctionOct 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY ABDOMINAL AORTIC ANEURYSM ARTIFICIAL BLOOD VESSEL REPLACEMENT, WHEN THE NEEDLE WAS INSERTED INTO ARTIFICIAL BLOOD VESSEL, THE THREAD SEPARATES FROM THE NEEDLE WHEN THE NEEDLE WAS PULLED OUT. IT WAS NOTED THAT THE TWO DEVICES USED WERE DOUBLE-ENDED NEEDLES, SO TWO NEEDLES WERE INSERTED INTO THE SPONGE AT EACH END. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673622 ↗
• MalfunctionJun 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE. THE HOSPITAL COLLECTED THE PRODUCT OF THE SAME LOT NUMBER AND REQUESTED AN INSPECTION.

  Patient problems: Insufficient Information

  MAUDE report 14832849 ↗