Surgipro II VP556X-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521758582), received between Feb 22, 2023 and Aug 17, 2026 — classified as 1 injury, 8 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.

• MalfunctionAug 17, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50288431 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. IT OCCURRED ON TWO SUTURES. A PRODUCT OF ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704477 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, WHILE SUTURING, THE SUTURE BROKE. IT OCCURRED ON TWO SUTURES. A PRODUCT OF ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704318 ↗
• MalfunctionJan 12, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY, WHILE ON VESSEL SUTURING, WHEN PIERCED, THE THREAD IMMEDIATELY BREAKS. A SECOND SUTURE FROM ANOTHER PACKAGE WITH THE SAME LOT WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505381 ↗
• MalfunctionDec 30, 2023Break; Break

  ACCORDING TO THE REPORTER, BOTH SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.

  Patient problems: Insufficient Information

  MAUDE report 18422697 ↗
• MalfunctionDec 20, 2023Break; Break

  ACCORDING TO THE REPORTER, THE FOUR SUTURE STRANDS WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.

  Patient problems: Insufficient Information

  MAUDE report 18364413 ↗
• MalfunctionDec 19, 2023Break; Break

  ACCORDING TO THE REPORTER, BOTH SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES.

  Patient problems: Insufficient Information

  MAUDE report 18358704 ↗
• InjuryDec 14, 2023Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, FOLLOWING A VASCULAR SURGERY, A COMPLICATION OCCURRED WHEN THREE SUTURES WERE ACCIDENTALLY CUT DURING THE SURGEON'S ATTEMPT TO REPAIR THE ARTERIES. AN OPERATION WAS CONDUCTED A WEEK LATER, REVEALING A LARGE HEMATOMA AT THE SURGICAL SITE, CONFIRMING SUTURE DEHISCENCE AS THE CAUSE, AN OCCURRENCE UNFAMILIAR TO THE SURGEON. THE PATIENT EXPERIENCED COMPLICATIONS A WEEK AFTER THE INITIAL SURGERY. FORTUNATELY, THE PATIENT WAS STILL HOSPITALIZED, PREVENTING WHAT COULD HAVE BEEN A TRAGEDY HAD THEY BEEN DISCHARGED. THE EVENT LED TO AN EXTENSION OF THE PATIENT'S HOSPITALIZATION.

  Patient problems: Hematoma; Wound Dehiscence

  MAUDE report 18327151 ↗
• MalfunctionFeb 22, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN THROMBECTOMY, AT PATCH SUTURING, THE THREAD OF THE TWO SUTURES BROKE. THE OPERATION TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE SURGERY WAS COMPLETED WITH A SUTURE FROM THE SAME LOT NUMBER. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419066 ↗