Hansen Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-1449-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

Product Classification:

Class II

Date Initiated: March 18, 2015

Date Posted: April 22, 2015

Recall Number: Z-1449-2015

Event ID: 70847

Reason for Recall:

Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.

Status: Terminated

Product Quantity: 19 total installed systems

Code Information:

All serial numbers.

Distribution Pattern:

Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated