Suture PassOR Pro RSG-14FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09349967000366), received between Oct 11, 2018 and Jul 6, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026

  AT THE END OF THE PROCEDURE WHEN THE SURGERY TEAM WAS ATTEMPTING TO USE THE CARTER THOMPSON CLOSURE DEVICE LAPAROSCOPICALLY, THE SHEATH PORTION OF THE DEVICE DISENGAGED UPON SURGEONS ATTEMPTING TO USE, BENDING THE DEVICE AND CAUSING THE SHEATH AND MAIN PART OF DEVICE TO COME APART INTO TWO PIECES AS IT WAS BEING PULLED OUT OF THE PATIENT. THIS RESULTED IN ONE PIECE BEING LEFT INSIDE THE PATIENT, WHICH IS NOT SUPPOSED TO HAPPEN. BOTH PIECES OF DEVICE WERE IMMEDIATELY REMOVED FROM PATIENT AND INSPECTED. ALL PARTS OF THE DEVICE APPEARED FULLY INTACT. ALTHOUGH THERE WAS LOW SUSPICION OF ANY ADDITIONAL PIECES OF DEVICE BEING BROKEN OFF OR LEFT INSIDE THE PATIENT, AN X-RAY WAS REQUESTED BY RN AT THE END OF THE PROCEDURE TO VERIFY THIS. RADIOLOGIST CONFIRMED NO FOREIGN BODIES RETAINED WITH EXCEPTION OF ENDO CLIPS X4 USED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25716105 ↗
• MalfunctionMay 21, 2026Break

  COMPLAINANT ALLEGES "THE SHEATH PORTION OF THE DEVICE DISENGAGED UPON SURGEONS ATTEMPTING TO USE, BENDING THE DEVICE AND CAUSING THE SHEATH AND MAIN PART OF DEVICE TO COME APART INTO TWO PIECES AS IT WAS BEING PULLED OUT OF THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250493 ↗
• MalfunctionApr 28, 2026Break

  COMPLAINANT ALLEGES "THE SUTURE PASSER SNAPPED IN HALF TWICE, CAUSING INCREASED BLEEDING FOR THEIR PATIENTS. WHEN IT BREAKS, THE SURGEON MUST RETRIEVE A PORTION LEFT INSIDE THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024048 ↗
• InjuryFeb 3, 2021Insufficient Device Problem Information

  FDA REPORT (B)(4): DOCTOR CALLED FROM HIS OFFICE. STATED THAT HE HAD REMOVED THE SHAFT FROM A PATIENT WHO HAD SURGERY IN SHORT STAY ONE MONTH PRIOR. ADDITIONAL INFORMATION: THE DEVICE DID NOT CAUSE SERIOUS INJURY TO THE PATIENT BUT IT DID REQUIRE THE PIECE TO BE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11271453 ↗
• MalfunctionOct 11, 2018Insufficient Device Problem Information

  FDA REPORT (B)(4): DOCTOR CALLED FROM HIS OFFICE. STATED THAT HE HAD REMOVED THE SHAFT FROM A PATIENT WHO HAD SURGERY IN SHORT STAY ONE MONTH PRIOR. ADDITIONAL INFORMATION: THE DEVICE DID NOT CAUSE SERIOUS INJURY TO THE PATIENT BUT IT DID REQUIRE THE PIECE TO BE REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7959014 ↗