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

Recall Insight

This FDA Devices action (record #Z-1449-2015) was formally reported on April 22, 2015, with the manufacturer initiating the action on March 18, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Hansen Medical Inc is listed as the recalling firm, operating out of Mountain View, CA. Federal records indicate 19 total installed systems units are affected.

The documented reason for this recall is: 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 cath… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.