FDA Medical Device Recalls (openFDA)
Hansen Medical Inc: 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 number
- Z-1564-2016
- Recalling firm
- Hansen Medical Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-03-25
- Posted
- not on file
- Terminated
- 2016-05-06
- 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.
- Root cause
- Under Investigation by firm
- Action
- Hansen Medical sent an Urgent Notice Product Recall notification dated March 28, 2016, to all affected customers. The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide the product to the Hansen Medical field representative to assure credit appropriately applied to their account. Customers with questions were instructed to contact their local Hansen Medical representative or call 650-404-5581.
- Quantity
- 8 kits
- Distribution
- Nationwide Distribution to OH, TX. FL, CA and GA.
- Lot, serial or model codes
- Lot number 20151117
- 510(k) numbers
- ["K111004","K132369","K141614","K151730"]
- PMA numbers
- not on file
- Product code
- DXX
- Firm FEI
- 3006026430
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28