Catheter PasserRecalls & reported problems across all models

We found 4 models of Catheter Passer by Medtronic Ps Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2020 and Sep 1, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Catheter Passer problems

Catheter Passer models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Catheter Passer 48409

  Catheter, percutaneous, intraspinal, short term
  11 reports
• Catheter Passer 8591-38

  Catheter, percutaneous, intraspinal, short term
  10 reports
• Catheter Passer 48407

  Catheter, percutaneous, intraspinal, short term
  3 reports
• Catheter Passer 8591-60

  Catheter, percutaneous, intraspinal, short term
  3 reports

Recent Catheter Passer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50551907 ↗
• 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 ↗
• MalfunctionApr 20, 2026Break; Fracture; Difficult to Insert

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO USE THE CATHETER PASSER DURING A VENTRICULOPERITONEAL SHUNT PROCEDURE, AND THE SHAFT OF THE PASSER SEEMED TO BE MORE MALLEABLE THAN INTENDED. THE DOCTOR WAS UNABLE TO SUCCESSFULLY PASS THE CATHETER THROUGH THE CATHETER PASSER. IT WAS NOTED THE CATHETER PASSER WAS TOO DAMAGED TO BE RETURNED. THE DOCTOR USED A SOLID REUSABLE PASSER TO COMPLETE THE PROCEDURE. THIS RESULTED IN A PROCEDURE DELAY OF 5 MINUTES. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24928162 ↗
• MalfunctionApr 20, 2026Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT ON (B)(6), 2026, THE PATIENT ENTERED THE OPERATING ROOM AND UNDERWENT A VENTRICULOPERITONEAL SHUNT PROCEDURE UNDER GENERAL ANESTHESIA DUE TO HYDROCEPHALUS. THE DEVICE USED INTRAOPERATIVELY WAS A CEREBROSPINAL FLUID FLOW CONTROL SHUNT AND ACCESSORIES SET. A SINGLE-USE TUNNELING TOOL WAS USED TO CREATE A SUBCUTANEOUS TUNNEL. AFTER THE TUNNELING TOOL WAS WITHDRAWN, IT WAS FOUND THAT THE TIP OF THE INNER STYLET HAD FRACTURED, WITH A MISSING PORTION MEASURING APPROXIMATELY 3.3 MM × 3.3 MM. AFTER THE EVENT OCCURRED, THE OPERATOR IMMEDIATELY STOPPED THE PROCEDURE. THE SURGICAL TEAM CONDUCTED A CAREFUL SEARCH WITHIN THE OPERATIVE FIELD, USED C-ARM FLUOROSCOPY, AND REQUESTED AN ULTRASOUND CONSULTATION. THE LEAD SURGEON CONFIRMED THAT THE MISSING FRAGMENT WAS NOT PRESENT IN THE PATIENT¿S BODY. THE HEAD NURSE AND THE BIOMEDICAL ENGINEERING DEPARTMENT WERE NOTIFIED IMMEDIATELY. THE CONSUMABLE WAS COMPREHENSIVELY INSPECTED. THE LEAD SURGEON REPORTED THAT THE DEVICE WAS USED NORMALLY DURING THE PROCEDURE, WITH NO EXCESSIVE FORCE OR IMPROPER HANDLING. NO HARM WAS CAUSED TO THE PATIENT. IT WAS NOTED THAT THIS PROLONGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927926 ↗
• 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 11, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE TIP OF CATHETER PASSER, USED FOR RIGHT VENTRICU LOPERITONEAL SHUNT INSERTION WITH LAPAROSCOPIC ASSIST, BROKE OFF DURING TUNNELLING.  SURGEON WAS UNABLE TO TO LOCATE OR RETRIEVE IN PATIENT. THE TIP WAS NOT RADIOPAQUE SO X-RAY IMAGING WAS NOT HELPFUL IN RETRIEVAL. SURGEON DECIDED TO LEAVE MISSING PIECE IN-SITU.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23777099 ↗
• 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 ↗
• MalfunctionNov 12, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE PLASTIC TIP OF THE CATHETER PASSER BROKE OFF DURING TUNNELING OF A NEW PERITONEAL CATHETER DURING A SHUNT REVISION. THE TIP WAS UNABLE TO BE FOUND. IT WAS NOTED THAT THERE WAS POTENTIAL FOR PATIENT HARM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23534246 ↗
• MalfunctionNov 10, 2025Break; Protective Measures Problem; Insufficient Device Problem Information; Break; Protective Measures Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REPORTED THAT THE HEALTHCARE PROVIDER TRIED TO FIND THE PLASTIC BUT BECAUSE IT WAS NOT RADIOPAQUE THEY COULD NOT LOCATE THE PIECE. THE INFORMATION WAS CONFIRMED WITH THE HEALTHCARE PROVIDER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23512166 ↗
• 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 ↗
• MalfunctionJun 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING AN 8591-60 PASSER. THE EVENT OCCURRED DURING SIMULATED USE PRE-CLINICAL STUDY CONDUCTED AT MEDTRONIC PRL WITH A CADAVER DONOR USING THE MODEL 8591 CATHETER PASSER. THE INTENT WAS TO GATHER SIMULATED USE DATA WITH REPRESENTATIVE PHYSICIAN USERS TO SUPPORT UPCOMING SUBMISSIONS TO EXPAND THE PRODUCT INDICATION TO INCLUDE SPINAL CORD STIMULATION (SCS). CURRENTLY THE MODEL 8591 CATHETER PASSER WAS INDICATED TO SUPPORT TARGETED DRUG DELIVERY (TDD) SYSTEMS. MODEL 8591 CATHETER PASSER WAS BEING USED TO TUNNEL. THE PHYSICIAN HAD USED THE TUNNELING TOOL TO CREATE A TUNNELING PATH, AND WHEN REMOVING THE OBTURATOR FROM THE TUNNELING TOOL, THE OBTURATOR TAB BROKE OFF OF THE OBTURATOR. THE REMAINING ACTIVITIES FOR THE SIMULATED USE STUDY SESSION WERE COMPLETED WITHOUT ANY OTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301762 ↗
• MalfunctionJun 5, 2025Break; Fracture; Break; Fracture

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE TROCAR HANDLE BROKE INTO 3 PIECES UPON SURGEON USE. THE PIECES WERE RECOVERED AND PLACED TOGETHER FOR VISUAL THAT ALL BROKEN PIECES WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152048 ↗
• 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 ↗

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