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Terminated

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

FDA Recall Z-1449-2015 · Posted 2015-04-15

Recalling FirmHansen Medical Inc
Recall StatusTerminated
Product CodeDXX
Date Initiated2015-03-18
Date Terminated2015-09-23
Product Quantity19 total installed systems

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.

Firm Action

Hansen Medical sent an Urgent Notice - Field Safety Notice dated March 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you review the information in pages 1 and 2 with Hansen Medical personnel and acknowledge your understanding by signing the Field Safety Notice Training Form on page 3. If you need any further information regarding this issue, please do not hesitate to contact me via telephone at 650-404-2784.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132369MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRHansen Medical, Inc. · 2013-09-27K111004HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETERHansen Medical, Inc. · 2012-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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