Surgipro II VP-761-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10884521039148), received between Sep 18, 2017 and Jul 8, 2026 — classified as 4 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751895 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CORONARY BYPASS PROCEDURE, DURING THE SUTURING PROCESS, THE NON-ABSORBABLE MONOFILAMENT POLYPROPYLENE SUTURE WAS USED FOR CLOSURE, AND THE NEEDLE AND SUTURE WERE DETACHED. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702204 ↗
• MalfunctionFeb 25, 2026Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE WHILE TYING A KNOT. ADDITIONALLY, THE NEEDLE AND SUTURE SEPARATED AFTER PASSING THROUGH TISSUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24447550 ↗
• MalfunctionFeb 16, 2026Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT ALLOGENEIC ORTHOTOPIC LIVER TRANSPLANTATION UNDER GENERAL ANESTHESIA. THE OPERATOR USED UNOPENED NON-ABSORBABLE MONOFILAMENT POLYPROPYLENE SUTURE, WHICH SHOWED NO VISIBLE ABNORMALITIES AND WAS WITHIN THE VALIDITY PERIOD, AND OPERATED ACCORDING TO THE INSTRUCTIONS FOR USE. THE INSTRUMENT NURSE HANDED THE PROPERLY HELD NON-ABSORBABLE MONOFILAMENT POLYPROPYLENE SUTURE TO THE SURGEON FOR VASCULAR SUTURING OF A BLEEDING VESSEL. AFTER SUTURING, WHEN PREPARING TO TIE THE KNOT, THE SUTURE BROKE, RESULTING IN THE INABILITY TO CLOSE THE VESSEL AND CAUSED INTRAOPERATIVE BLEEDING. UPON DISCOVERING THE BLEEDING, THE SURGEON IMMEDIATELY REMOVED THE BROKEN SUTURE, WHILE THE INSTRUMENT NURSE SIMULTANEOUSLY REPLACED IT WITH A NEW NON-ABSORBABLE MONOFILAMENT POLYPROPYLENE SUTURE FOR RE-SUTURING. AFTER THE NEW SUTURE WAS USED INSTEAD TO COMPLETE VASCULAR CLOSURE, THE SURGERY CONTINUED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24349527 ↗
• InjuryDec 12, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIAC SURGERY, THE SCRUB NURSE DISCOVERED THAT THE TIP OF THE NON-ABSORBABLE MONOFILAMENT POLYPROPYLENE SUTURE WAS MISSING A 1 X 0.5 MM FRAGMENT WHILE COLLECTING NEEDLES. THE SURGICAL TEAM WAS IMMEDIATELY NOTIFIED TO BEGIN SEARCHING, AND THE OPERATING ROOM SUPERVISOR, HEAD NURSE, AND CHIEF OF CARDIOVASCULAR SURGERY WERE INFORMED. ADDITIONAL PERSONNEL WERE DISPATCHED TO ASSIST WITH THE SEARCH. THE SCRUB NURSE AND SURGICAL TEAM, WHILE ENSURING PATIENT SAFETY, CAREFULLY INSPECTED AND USED A NEEDLE FINDER TO EXAMINE THE OPERATING TABLE, INSTRUMENT TABLE, STERILE ABDOMINAL DRAPES, SURGICAL FIELD AND INCISION AREA, AND INSIDE THE INCISION. THE CIRCULATING NURSE USED A NEEDLE FINDER TO THOROUGHLY INSPECT THE OPERATING ROOM FLOOR, UNDER THE SURGICAL BED, SURFACES OF INSTRUMENTS AND EQUIPMENT, THE CLOTHING AND SHOE SOLES OF THE SURGICAL TEAM, AND EVERY CORNER OF THE OPERATING ROOM. ALL GAUZE, SUCTION BOTTLES, AND GARBAGE BAGS WERE SEARCHED WITH NO FINDINGS. C-ARM FLUOROSCOPY OF THE SURGICAL FIELD AND THE BLOOD RECOVERY CONTAINER REVEALED NO SUSPICIOUS NEEDLE TIP IMAGES. AFTER CONSULTING THE SURGEON, THE BREAKAGE MAY HAVE OCCURRED WHEN THE NEEDLE TIP WAS

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23788452 ↗
• MalfunctionJun 11, 2025Break; Break

  IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, THERE WERE ISSUES WITH THE SUTURE BREAKING AND PILLING ON THE STRAND. THE SUTURE WAS REPLACED WITH THE SAME SUTURE BUT A DIFFERENT LOT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22183567 ↗
• MalfunctionJun 4, 2025Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURES BROKE IN THE MIDDLE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. ADDITIONALLY, THERE WAS DIFFICULTY IN REMOVING THE SUTURES FROM THE RETAINER/PACKAGING. A DIFFERENT PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146727 ↗
• MalfunctionJun 4, 2025Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURES BROKE IN THE MIDDLE WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION. ADDITIONALLY, THERE WAS DIFFICULTY IN REMOVING THE SUTURES FROM THE RETAINER/PACKAGING. A DIFFERENT PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146184 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, THERE WERE ISSUES WITH THE SUTURE BREAKING AND PILLING ON THE STRAND.

  Patient problems: Insufficient Information

  MAUDE report 22142319 ↗
• MalfunctionJun 3, 2025Break; Break

  IT WAS REPORTED THAT DURING THE USE OF THE SUTURE, THERE WERE ISSUES WITH THE SUTURE BREAKING AND PILLING ON THE STRAND.

  Patient problems: Insufficient Information

  MAUDE report 22138242 ↗
• MalfunctionJun 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON OPENING THE PACKAGING, THE SUTURE WAS BROKEN IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE OTHER FOUR SUTURES FROM THE SAME BATCH. A DIFFERENT, NON-DEFECTIVE PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROC EDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125488 ↗
• MalfunctionJun 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON OPENING THE PACKAGING, THE SUTURE WAS BROKEN IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE OTHER FOUR SUTURES FROM THE SAME BATCH. A DIFFERENT, NON-DEFECTIVE PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125173 ↗
• MalfunctionJun 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON OPENING THE PACKAGING, THE SUTURE WAS BROKEN IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE OTHER FOUR SUTURES FROM THE SAME BATCH. A DIFFERENT, NON-DEFECTIVE PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125056 ↗
• MalfunctionJun 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON OPENING THE PACKAGING, THE SUTURE WAS BROKEN IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE OTHER FOUR SUTURES FROM THE SAME BATCH. A DIFFERENT, NON-DEFECTIVE PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125007 ↗
• MalfunctionJun 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, UPON OPENING THE PACKAGING, THE SUTURE WAS BROKEN IN THE MIDDLE. THE SAME ISSUE OCCURRED ON THE OTHER FOUR SUTURES FROM THE SAME BATCH. A DIFFERENT, NON-DEFECTIVE PRODUCT OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125002 ↗
• MalfunctionJun 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PANCREATICOJEJUNOSTOMY, WHILE SUTURING THE NEEDLE AND SUTURE DETACHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19511076 ↗
• MalfunctionMay 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PANCREATICOJEJUNOSTOMY, WHILE SUTURING, THE NEEDLE AND SUTURE DETACHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19290805 ↗
• MalfunctionMay 10, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PANCREATICOJEJUNOSTOMY, WHILE SUTURING THE NEEDLE AND SUTURE DETACHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19289986 ↗
• MalfunctionFeb 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREE SUTURES BROKE, THERE WAS TENSION WHEN PULLING THE SUTURE OUT, IT BROKE PRIOR TO BEING HANDED TO THE SURGEON, AND IT ALSO BROKE DURING KNOT TYING. OPEN A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641612 ↗
• MalfunctionFeb 5, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREE SUTURES BROKE, THERE WAS TENSION WHEN PULLING THE SUTURE OUT, IT BROKE PRIOR TO BEING HANDED TO THE SURGEON, AND IT ALSO BROKE DURING KNOT TYING. OPEN A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641511 ↗
• MalfunctionJan 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREE SUTURES BROKE, THERE WAS TENSION WHEN PULLING THE SUTURE OUT, IT BROKE PRIOR TO BEING HANDED TO THE SURGEON, AND IT ALSO BROKE DURING KNOT TYING. OPEN A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472912 ↗
• MalfunctionJan 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREE SUTURES BROKE, THERE WAS TENSION WHEN PULLING THE SUTURE OUT, IT BROKE PRIOR TO BEING HANDED TO THE SURGEON, AND IT ALSO BROKE DURING KNOT TYING. OPEN A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472901 ↗
• MalfunctionSep 6, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, IN THE ATRIUM, THE THREAD OF TWO SUTURES BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690654 ↗
• MalfunctionApr 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT (CABG), THE SUTURE BROKE WHEN THE SURGEON WAS ATTACHING THE CANNULA. A COMPETITOR'S SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832728 ↗
• MalfunctionApr 27, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT WITH MITRAL VALVE REPAIR, THE SUTURE THREAD BROKE WHEN THE SURGEON WAS ATTACHING THE CANNULA. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828541 ↗