MAJClass II
Catheter, Percutaneous, Intraspinal, Short Term
Anesthesiology · 21 CFR 868.5120
MDR events82All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances6All time
Recent MDR events
82 adverse event reports on file
- CATHETER PASSERJul 21, 2026MalfunctionMedtronic Dominicana9612501-2026-02006
- CATHETER PASSERJun 4, 2026InjuryMedtronic Neuromodulation2182207-2026-01542
- CATHETER PASSERMay 12, 2026MalfunctionMedtronic Ps Medical, Inc.25148421
- CATHETER PASSERMay 5, 2026InjuryMedtronic Dominicana9612501-2026-01268
- CATHETER PASSERMay 1, 2026InjuryMedtronic Neuromodulation2182207-2026-01150
- CATHETER PASSERApr 24, 2026MalfunctionMedtronic Dominicana9612501-2026-01154
- CATHETER PASSERApr 20, 2026MalfunctionMedtronic Dominicana9612501-2026-01111
- CATHETER PASSERApr 20, 2026MalfunctionMedtronic Dominicana9612501-2026-01113
- CATHETER PASSERApr 17, 2026InjuryMedtronic Neuromodulation2182207-2026-01021
- CATHETER PASSERMar 26, 2026InjuryMedtronic Neuromodulation2182207-2026-00805
Event type breakdown
Malfunction52
Injury28
Other2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Medtronic VascularMar 18, 1997
K965251 · MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
- Medtronic VascularMay 24, 1995
K945413 · MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT
- Medtronic VascularMay 24, 1995
K934939 · TEMPORARY SCREENING LEAD/ CATHETER KIT
- Concord/PortexJul 27, 1993
K930218 · SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
- Pudenz-Schulte Medical Research Corp.Jul 18, 1991
K911382 · IPI ALGO-LINE CATHETER
- Abbott LaboratoriesNov 1, 1989
K893766 · LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE