Catheter Passer 8591-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000031404), received between Nov 9, 2020 and May 12, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026

  DURING THE PROCEDURE FOR A HYPOGLOSSAL NERVE STIMULATOR IMPLANT, THE DOCTOR STARTED TO TUNNEL WITH THE CATHETER PASSER TO ATTACH THE LEAD TO THE UNIT. WHEN DOING SO THE TIP OF THE PASSER BROKE OFF INSIDE THE PATIENT. THE DOCTOR WAS ABLE TO FIND THE TIP; HOWEVER THE PATIENT STARTED TO HAVE INCREASE IN BLEEDING, AND HIS BLOOD PRESSURE STARTED TO DROP. PATIENT GOT STABILIZED, BUT WE HAD TO CALL VASCULAR AND CARDIAC SURGERY TO COME ASSESS AND THE PATIENT BECAUSE BLEEDING WAS DIFFICULT TO CONTROL. ANESTHESIA ORDERED AND GAVE TWO UNITS OF BLOOD. ONCE THOSE PHYSICIANS ARRIVED AND ASSESSED THE SITUATION, THE VASCULAR SURGEON WAS ABLE TO REPAIR THE INTERNAL JUGULAR VEIN AND THE PATIENT WAS STABILIZED. SURGICAL PROCEDURE WAS FINISHED AND PATIENT WAS TAKEN OVER TO THE MAIN OR PACU [POST ANESTHESIA RECOVERY UNIT], WHILE PATIENT REMAINED STABLE. PRODUCT INFO: REF# 8591-38 CATHETER PASSER DISPOSABLE VENDOR MEDTRONIC LOT # 0232769169 EXP: 10/26/2030

  Patient problems: Failure of Implant; Foreign Body In Patient; Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 25148421 ↗
• MalfunctionApr 24, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE WHO REPORTED THAT DURING THE IMPLANT PROCEDURE, THE TUNNELING TOOL TAB BROKE WHEN REMOVING THE PLASTIC PIECE FROM HANDLE TO PULL IT THROUGH THE TUNNELER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981705 ↗
• MalfunctionMar 20, 2026Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REGARDING A TUNNELING TOOL. IT WAS REPORTED THAT APPARENTLY PIECES BROKE OFF OF TWO PASSERS DURING THE CASE. THEY DISCARDED THE PASSERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649497 ↗
• MalfunctionDec 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTED INFUSION PUMP. IT WAS REPORTED THAT WHEN THE SURGEON WAS USING THE CATHETER PASSER, THE TIP BROKE DURING REMOVAL. THE SURGEON DID NOT REALIZE IT AT THAT TIME, BUT THE PIECE WAS FOUND PRIOR TO COMPLETION. THE REPORTER WAS CONCERNS ABOUT IF THEY DID NOT REALIZE THAT IT HAPPENED AND WHAT WOULD HAPPEN. TIP REINFORCEMENT WAS SUGGESTED TO THE MANUFACTURER. IT WAS NOTED THAT THE REP WAS NOT PRESENT DURING THE PROCEDURE AND THE PRODUCT WAS BEING USED TO IMPLANT A NON-MEDTRONIC DEVICE. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS UNKNOWN IF ANY DIAGNOSTICS/TROUBLESHOOTING PERFORMED. IT WAS UNKNOWN IF THERE WERE ANY INTERVENTIONS/ACTIONS TAKEN TO RESOLVE THE ISSUE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. IT WAS NOTED THAT THE HCP HAD NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732690 ↗
• MalfunctionAug 26, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE TUNNELING TOOL WAS BROKEN. NO ACTIONS WERE TAKEN, AND THE ISSUE WAS NOT RESOLVED. SURGICAL INTERVENTION OCCURRED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS EVENT OCCURRED DURING NORMAL IMPLANT. THE BROKEN TUNNELING TOOL WAS USED. A CAUSE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895594 ↗
• MalfunctionJul 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING TUNNELING FOR THE LEAD, THE TUNNELING HEAD CAME OFF THE ROD. THERE WERE NO EXTERNAL FACTORS, AND NO TROUBLESHOOTING WAS PERFORMED. THE REPRESENTATIVE NOTED THAT THE IMPLANTING SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585499 ↗
• MalfunctionNov 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT DURING A SURGERY THIS TUNNELER (I.E., CATHETER PASSER) WAS PASSED TO THE SURGEON. THE SURGEON PLACED THEIR HAND ON THE PLASTIC HANDLE OF THE TUNNELER AND THEIR SURGICAL GLOVE WAS CUT OPEN. IT WAS IDENTIFIED THAT THE CLEAR PLASTIC HANDLE OF THE TUNNELER WAS CHIPPED AND A PIECE OF PLASTIC WAS PROTRUDING OUT, WHICH CUT THE SURGEON'S GLOVE. THE TUNNELER WAS REPLACED DURING THE PROCEDURE WITH ANOTHER TUNNELER FROM THE REP'S TRUNK STOCK THE CLINICIAN'S OFFICE DISCARDED THE TUNNELER IN THE SHARPS BOX. THE REP REPORTED THIS APPEARED TO BE A MANUFACTURER DEFECT. THE REP HAD INSPECTED THE STERILE PACKAGING AFTER THE INCIDENT AND FOUND THE PACKAGING TO BE INTACT WITHOUT ANY HOLES. NO SYMPTOMS REPORTED. REP CONFIRMED THIS SURGICAL PROCEDURE WAS A SPINAL CORD STIMULATION DEVICE IMPLANT. THE TUNNELER WITH THE CHIPPED HANDLE WAS USED TO PASS THE WIRES UNDER THE SKIN FROM THE LEAD INCISION TO THE BATTERY POCKET. THE REP DID NOT HAVE AN OPPORTUNITY TO TAKE ANY PHOTOS OF THE DEFECTIVE TUNNELER OR THE PACKAGING. THEY EXPLAINED THAT THE SURGEON THREW THE TUNNELER ON THE FLOOR AND IT WAS IMMEDIATELY PLACED IN THE SHARPS BIN IN THE ROOM BY THE CIRCULAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679697 ↗
• MalfunctionOct 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION REPORTED FROM THE COMPANY REPRESENTATIVE (REP) THAT THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920805 ↗
• MalfunctionJan 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE. THE PATIENT¿S INITIALS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121931 ↗
• MalfunctionNov 9, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PROBLEM WITH AN INFUSION CATHETER PASSER BEING USED FOR SPINAL CORD STIMULATION PROCEDURES. THE HCP WANTED TO REPORTED A PRODUCT QUALITY ISSUE WITH THE CATHETER PASSER. THE HCP STATED THAT LATELY ANYTIME THE PHYSICIAN TRIED TO RELEASE THE TAB ON THE PASSER IT WAS VERY HARD TO RELEASE AND WOULD THEN BREAK OFF. THE HCP WAS USING THE CATHETER PASSER TO PASS LEADS FOR SPINAL CORD STIMULATION. THE MOST RECENT ISSUE OCCURRED ON (B)(6) 2020. (SEE MANUFACTURER¿S REPORT NUMBER 2182207-2020-00981 FOR THE UNKNOWN PASSERS.) ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). IT WAS REPORTED THE SAME ISSUE OCCURRED AGAIN ON (B)(6) 2020. AS THE PHYSICIAN WAS RELEASING THE TAB FROM THE TUNNELLER A PIECE OF THE TAB BROKE OFF. IT WAS REPORTED THAT NONE OF THESE ISSUES IMPACTED THE PATIENT IN ANY WAY. THE CATHETER PASSER WAS DISPOSED AFTER EVERY CASE SO NONE WERE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10808347 ↗