Surgipro II VP-557XRecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10884521037915), received between May 16, 2017 and Jun 29, 2026 — classified as 6 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING BYPASS SURGERY, THE SUTURE EXPERIENCED NEEDLE¿SUTURE DETACHMENT WHEN CONTINUOUS SUTURING WAS BEING PERFORMED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648949 ↗
• InjuryJan 16, 2026Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE TO SUTURE THE PERICARDIAL SURFACE TISSUE, IT WAS DISCOVERED AFTER USE THAT APPROXIMATELY 2 MM OF THE NEEDLE TIP WAS MISSING. A COMPREHENSIVE SEARCH WAS CONDUCTED IN THE THORACIC CAVITY, AROUND THE INCISION SITE, ON THE FLOOR, AND IN THE SUCTION CANISTER, AND BOTH C-ARM FLUOROSCOPY AND DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING WERE PERFORMED HOWEVER, NO FOREIGN OBJECT WAS DETECTED. BASED ON MEDICAL ADVICE, THE INCISION WAS SUBSEQUENTLY CLOSED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24104802 ↗
• MalfunctionFeb 25, 2025Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUTURE BROKE WHILE SUTURING, SPECIFICALLY IN THE MIDDLE. ADDITIONALLY, THE THREAD FELT STUCK WHEN FIRST TAKEN OUT, ALTHOUGH IT EVENTUALLY CAME OUT SMOOTHLY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461564 ↗
• MalfunctionFeb 25, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE MITRAL VALVE REPLACEMENT SURGERY, THE SUTURE THREAD CRACKED. ANOTHER NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 21460962 ↗
• MalfunctionNov 15, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING THE WOUND, THE SUTURE BROKE. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH A NEW PRODUCT WHICH DELAYED THE OPERATION TIME AND INCREASED THE RISK OF UNCERTAINTY.

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

  MAUDE report 18144260 ↗
• MalfunctionAug 23, 2023Break; Material Frayed; Adverse Event Without Identified Device or Use Problem; Break; Material Frayed; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A CORONARY ARTERY BYPASS GRAFT (CABG), WHILE TYING KNOTS IN PLACE, THE 4-0 DIAMETER SUTURE WAS BREAKING AND FRAYING, ANOTHER 4-0 DIAMETER SUTURE WAS USED HOWEVER THE SAME ISSUE OCCURRED. THEY USED A 6-0 DIAMETER HOWEVER THE SAME ISSUE OCCURRED. THERE WAS TISSUE DAMAGE AS THE VEIN THAT WAS HARVESTED HAD TO BE CUT AND RE-SUTURED AT THE ANASTOMOSIS OF THE BYPASS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Tissue Breakdown

  MAUDE report 17607026 ↗
• MalfunctionAug 17, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING HEPATOBILIARY SURGERY, THE SUTURE BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569460 ↗
• InjuryJul 24, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE TO A LIPOMA REMOVAL PROCEDURE, THE PATIENT CAME TO THE HOSPITAL AND COMPLAINED THAT THE SKIN AT THE SUTURE WAS ITCHY AND SLIGHTLY PAINFUL TO THE TOUCH. THE SURGEON CHECKED THE SKIN OF THE PATIENT'S WOUND AND FOUND THAT THE SKIN AT THE SUTURE WITH NON-ABSORBABLE SINGLE-STRAND POLYPROPYLENE SUTURE WAS SLIGHTLY RED AND SWOLLEN. THE SURGEON IMMEDIATELY CLEANED THE WOUND WITH NORMAL SALINE FOR THE PATIENT AND DISINFECTED THE WOUND WITH MEDICAL ALCOHOL. FOR THE TIME BEING, NO DRESSING WAS USED TO COVER THE SKIN AT THE SUTURE AND IT WAS ADVISED TO KEEP THE WOUND SKIN DRY, SEEK MEDICAL ADVICE IN TIME IF THERE IS ANY DISCOMFORT, AND FOLLOW UP IN THE OUTPATIENT CLINIC.

  Patient problems: Inflammation; Local Reaction; Pain

  MAUDE report 17376813 ↗
• MalfunctionJun 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN MITRAL VALVE REPLACEMENT, AT THE TIME OF SUTURING THE RIGHT ATRIAL APPENDAGE, THE NEEDLE TIP BROKE. THE THREAD ALSO BROKE AS SEEN IN THE IMAGE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838010 ↗
• MalfunctionMar 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC PROCEDURE, WHILE REPAIRING DEFECT IN THE ATRIAL SEPTAL DEFECT, THE NE EDLE TIP WAS BROKEN AT THE TENTH STITCH OF CONTINUOUS SUTURE. ANOTHER SUTURE WAS USED AS A REPLACEMENT AND THERE WILL BE SUTURING AGAIN TO COMPLETE THE CASE RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13644275 ↗
• MalfunctionMar 1, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC ATRIAL SEPTAL DEFECT REPAIR, WHILE REPAIRING THE ATRIAL SEPTAL DEFECT, THE NEEDLE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13644030 ↗
• MalfunctionJan 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, PRIOR A CONTINUOUS STITCH, THE NEEDLE DETACHED FROM THE THREAD. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154119 ↗
• MalfunctionDec 7, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VASCULAR PROCEDURE, WHILE PERFORMING EVERSION SUTURING ON THE BLOOD VESSELS, THE THREAD BROKE. THE USER REPLACED WITH THE SUTURE OF ANOTHER PACKAGING TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 12954340 ↗
• MalfunctionMay 10, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CARDIOVASCULAR SURGERY, WHILE SUTURING THE TISSUE, THE NEEDLE TIP BROKE AND FELL INTO THAT PATIENT'S CAVITY. IT WAS VISUALLY CHECKED AND COLLECTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798698 ↗
• MalfunctionDec 30, 2020Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC RETRO PERITONEAL LYMPH NODE DISSECTION, DURING THE THROW, THE THREAD BROKE. ANOTHER DEVICE FROM ANOTHER LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094147 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING A RUNNING STITCH DURING A CORONARY ARTERY BYPASS GRAFT/VALVE REPLACEMENT, THE THREAD OF THE DEVICE BROKE. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10781167 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, WHILE EMPLOYING A RUNNING SUTURING TECHNIQUE, THE SUTURE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780422 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780294 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE AND THE OPERATOR USED ANOTHER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780216 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE AND WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780137 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE THREAD BROKE WHILE USING RUNNING SUTURING TECHNIQUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780120 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE THREAD BROKE WHILE USING RUNNING SUTURING TECHNIQUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779936 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE BROKE AND IT WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779892 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE BROKE. AN ADDITIONAL NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779298 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CARDIAC SURGERY, WHILE THE SURGEON DOING A RUNNING SUTURING TECHNIQUE, THE THREAD BROKE. ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779088 ↗