Devices

Device Recall Magellan Robotic Catheter System Accessory Kits

Model / Serial
Lot number 20151117
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to OH, TX. FL, CA and GA.
Product Description
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.
Manufacturer
Hansen Medical Inc
1 Event
- Recall of Device Recall Magellan Robotic Catheter System Accessory Kits

Manufacturer

Hansen Medical Inc

Manufacturer Address
Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
Manufacturer Parent Company (2017)
Auris Health, Inc.
Source
USFDA

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