FDA Device recall Z-1794-2015
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935
- FDA Device
- Class II
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class II recall of Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935 by Medtronic Navigation, citing passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1794-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-05 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | CA, LA, MO, PA |
Product
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
Reason
Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
Identifiers
| code_info | lot number 150223 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1794-2015%22
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