Hansen Medical Inc: Medical Device Recall in 2016 - (Recall #: Z-1564-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 25, 2016

Date Posted: May 4, 2016

Recall Number: Z-1564-2016

Event ID: 73677

Reason for Recall:

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.

Status: Terminated

Product Quantity: 8 kits

Code Information:

Lot number 20151117

Distribution Pattern:

Nationwide Distribution to OH, TX. FL, CA and GA.

Voluntary or Mandated:

Voluntary: Firm initiated