Surgipro II VP703X-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521758223), received between Sep 15, 2020 and Jun 20, 2025 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURES WERE BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296243 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURES WERE BROKEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296223 ↗
• MalfunctionJan 19, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE TWO TIMES.

  Patient problems: Insufficient Information

  MAUDE report 18544556 ↗
• MalfunctionJul 31, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A REDO LAMINECTOMY, DISCECTOMY AND DUROTOMY REPAIR PROCEDURE, THE SURGEON WAS USING A 6-0 SUTURE, AND THE NEEDLE BROKE IN HALF. BOTH PIECES WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17429763 ↗
• MalfunctionAug 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VASCULAR SURGERY, AT THE INITIAL RUNNING SUTURING, THE THREAD BROKE. A NEW SUTURE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298298 ↗
• DeathMar 5, 2021Unraveled Material; Patient Device Interaction Problem; Unraveled Material; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, TWO DAYS POST-OPERATIVELY OF A CORONARY ARTERY BYPASS SURGERY X3 USING CARDIOPULMONARY BYPASS: LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING ARTERY (LAD); SAPHENOUS VEIN GRAFT TO D1; AND SAPHENOUS VEIN GRAFT TO OM1, AN ANASTOMOTIC SUTURE ON A BYPASS GRAFT FRACTURED AND DISRUPTED IN ITS MID-PORTION, ENGENDERING A LIFE-THREATENING EMERGENCY FOR THE PATIENT. PATIENT SUSTAINED CARDIAC ARREST, MEDIASTINAL HEMATOMA, AND CHEST OPENED AT BEDSIDE IN INTENSIVE CARE UNIT (ICU). THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR EMERGENT REOPERATIVE CORONARY ARTERY BYPASS X1 USING CARDIOPULMONARY BYPASS: LEFT INTERNAL MAMMARY ARTERY TO LAD, REVISION OF CENTRAL EXTRACORPOREAL MEMBRANE OXYGENATOR (ECMO DEVICE TO PERIPHERAL VA-ECMO (RIGHT AXILLARY ARTERY), AND PERCUTANEOUS INSERTION OF INTRA-AORTIC BALLOON PUMP. IT WAS ALSO STATED THAT PROSTHETIC VASCULAR TUBE IMPLANTS NEVER HEAL BUT RATHER DELAY FOR DECADES ON THE INTEGRITY OF THE ANASTOMOTIC SUTURE MATERIAL. THE PATIENT DIED.

  Patient problems: Cardiac Arrest; Failure to Anastomose; Hematoma

  MAUDE report 11420749 ↗
• MalfunctionSep 15, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE ON THE CAROTID ARTERY, WHILE PERFORMING ANASTOMOSIS, 3 SUTURE THREADS BROKE AS THE SURGEON WAS LIFTING THE NEEDLE OUT OF THE TISSUE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535858 ↗