The Recall Desk
HighFDA (Devices)·Z-1449-2015·Announced 2015-04-22

Hansen Medical Recalls Magellan Robotic Systems Due to Catheter Retraction Defect

Hansen Medical is recalling 19 Magellan Robotic Systems because the catheter may fail to stop retracting when the control button is released.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect that could lead to unintended catheter movement during a procedure. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Hansen Medical Inc. is recalling 19 installed units of the Magellan Robotic System, Model Nos. 11132 and 11139. This steerable catheter control system is used at clinical sites. The recall covers all serial numbers of the affected models.

The recall was initiated following an investigation of two complaint incidents. The investigation found that the equipment may experience an unexpected event during a catheter retraction operation. Specifically, the retraction of the catheter may not stop when the equipment button is released.

The affected systems were distributed worldwide, including in the United States, Saudi Arabia, Australia, France, Italy, Germany, and the United Kingdom. Clinical sites using these systems should contact Hansen Medical for further instructions regarding the recall.

The recalled product

Product
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Manufacturer
Hansen Medical Inc
Category
Medical Device — Surgical Robotics
Hazard
Affected units
19

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers.

Distribution

Distribution scope not specified by the agency.

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