Surgipro II XX-5158Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521137028), received between Sep 17, 2021 and Jun 29, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT, AT THE TIME OF OPENING, THE NUMBER OF THE NEEDLES IN THE PACKAGE WAS INCORRECT. THERE WERE FEWER NEEDLES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25660714 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG), IN VASCULAR ANASTOMOSIS, DURING SUTURING, THE THREAD OF THE TWO DEVICES BROKE AROUND THE MIDDLE AND ON THE OTHER TWO SUTURES, THE THREAD WAS UNINTENTIONALLY DETACHED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405065 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG), IN VASCULAR ANASTOMOSIS, DURING SUTURING, THE THREAD OF THE TWO DEVICES BROKE AROUND THE MIDDLE AND ON THE OTHER TWO SUTURES, THE THREAD WAS UNINTENTIONALLY DETACHED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405002 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG), IN VASCULAR ANASTOMOSIS, DURING SUTURING, THE THREAD OF THE TWO DEVICES BROKE AROUND THE MIDDLE AND ON THE OTHER TWO SUTURES, THE THREAD WAS UNFASTENED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383967 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT (CABG), IN VASCULAR ANASTOMOSIS, DURING SUTURING, THE THREAD OF THE TWO DEVICES BROKE AROUND THE MIDDLE AND ON THE OTHER TWO SUTURES, THE THREAD WAS UNFASTENED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383956 ↗
• MalfunctionFeb 11, 2026Break

  ACCORDING TO THE REPORTER, IN A CORONARY ARTERY BYPASS GRAFT (CABG), DURING VASCULAR ANASTOMOSIS SUTURING, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311010 ↗
• MalfunctionJul 21, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THERE WAS INCORRECT QUANTITY OF SUTURES IN PACKAGE. OPENED A NEW PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561610 ↗
• MalfunctionMay 16, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A BLOOD VESSEL ANASTOMOSIS, THE TWO DEVICE SNAPS BETWEEN THE HAND AND THE LIGATION SITE DURING SUTURING. IT WAS NOT AT THE SUTURE SITE OR THE NODAL POINT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037562 ↗
• MalfunctionMay 16, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A BLOOD VESSEL ANASTOMOSIS, THE TWO DEVICE SNAPS BETWEEN THE HAND AND THE LIGATION SITE DURING SUTURING. IT WAS NOT AT THE SUTURE SITE OR THE NODAL POINT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037539 ↗
• MalfunctionMar 13, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS SURGERY, WHEN ANASTOMOSING THE CORONARY AND BLOOD VESSELS VIA CONTINUOUS SUTURING, THE SUTURE BROKE. IT OCCURRED ON NINE SUTURES FROM THE SAME LOT NUMBER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534939 ↗
• MalfunctionFeb 16, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS LAPAROTOMY, ON VASCULAR ANASTOMOSIS, WHEN A PULLING FORCE WAS APPLIED ON A UNIT IN THE PACKET, IT BROKE WITH A CLEARLY WEAKER FORCE THAN USUAL. A PRODUCT FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16389940 ↗
• MalfunctionSep 23, 2022Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING OPEN CORONARY-ARTERY BYPASS, AT ANASTOMOSIS OF CORONARY ARTERY AND GRAFT VESSEL, THE THREAD OF MULTIPLE SUTURES FROM THE SAME PACKET BROKE. THE NURSE COMMENTED THAT THREAD FELT LIKE IT GOT CAUGHT WHEN REMOVING FROM THE SPONGE FOR THREAD FIXATION. THE REMAINING SUTURES FROM THE PACKET WAS NOT USED AND NEW SUTURE FROM ANOTHER PACKET WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471653 ↗
• MalfunctionSep 17, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL CORONARY ARTERY BYPASS, THERE WAS THREAD BREAKAGE AND NEEDLE DAMAGE IN SEVERAL PRODUCTS OF THE SAME LOT. THEREFORE, THE SAME LOT OF PRODUCT WAS NOT USED, AND THERE WERE NO PROBLEMS USING THE SAME SPECIFICATION OF ANOTHER LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487601 ↗