NA 8591-38Recalls & reported problems
Medtronic Ps Medical, Inc. · PASSER 8591-38 CATHETER-38CM · Class 2
Data updated Oct 16, 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 00673978226842), received between Dec 1, 2017 and Dec 16, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WASRECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER'S REPRESENTATIVE ON 2019-DEC-16. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE TUNNELING TOOL HANDLING CRACKING. THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9475639 ↗MalfunctionJun 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2019, INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP), REGARDING A CATHETER PASSER (8591-38). DURING THE PROCEDURE, THE TUNNELING OBTURATOR BROKE WHILE THE PHYSICIAN WAS RESHAPING THE CATHETER PASSER. A NEW PASSER WAS OPENED AND USED. NO PATIENT IMPACT REPORTED. THE ISSUE WAS RESOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8664450 ↗MalfunctionDec 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A CATHETER PASSER. IT WAS REPORTED THAT THE HANDLE OF THE CATHETER PASSER CRACKED WHEN TAKING THE HANDLE OFF. NO INTERVENTIONS WERE NEEDED AND THE RESOLUTION WAS UNKNOWN. NO SURGICAL INTERVENTION OCCURRED AND NONE WAS PLANNED. THE PATIENT'S STATUS WAS NOTED TO BE "ALIVE-NO INJURY". THE PATIENT'S MEDICAL HISTORY INCLUDED ARM PAIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7074310 ↗
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 8591-60Medtronic Ps Medical, Inc. · Catheter, percutaneous, intraspinal, short term3 reports
- Catheter Passer 48407Medtronic 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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