Catheter Passer 8591-60Recalls & reported problems
Medtronic Ps Medical, Inc. · PASSER 8591-60 CATHETER-60CM · Class 2
All models of Catheter Passer (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000031411), received between Jun 20, 2025 and Sep 1, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, 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 ↗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 ↗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 ↗
Other Catheter, percutaneous, intraspinal, short term devices
- Catheter Passer 48409Medtronic Ps Medical, Inc. · Catheter, percutaneous, intraspinal, short term11 reports
- Catheter Passer 8591-38Medtronic Ps Medical, Inc. · Catheter, percutaneous, intraspinal, short term10 reports
- Cathter Passer, Disposable 48407Medtronic Ps Medical, Inc. · Catheter, percutaneous, intraspinal, short term3 reports
- Catheter Passer 48407Medtronic Ps Medical, Inc. · Catheter, percutaneous, intraspinal, short term3 reports
- NA 8591-38Medtronic Ps Medical, Inc. · CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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