FDA Enforcement
Class II
Terminated
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.
Recall: Z-1564-2016
·
Reported May 4, 2016
Enforcement
- Recall Number
- Z-1564-2016
- Event ID
- 73677
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hansen Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 4, 2016
- Initiation Date
- March 25, 2016
- Classification Date
- April 25, 2016
- Termination Date
- May 6, 2016
- Address
- 800 E Middlefield Rd, N/A, Mountain View, CA, 94043-4030, United States
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.
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.
Code Info
Lot number 20151117
Distribution
Nationwide Distribution to OH, TX. FL, CA and GA.
Quantity
8 kits