FDA Device recall Z-1564-2016
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80 by Hansen Medical, citing firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1564-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-25 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hansen Medical |
| Distribution | US |
Product
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
Reason
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
Identifiers
| code_info | Lot number 20151117 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1564-2016%22
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