Recall Z-1564-2016— Hansen Medical Inc

Name: FDA recall Z-1564-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-25

Class II · Terminated

Class II FDA medical device recall by Hansen Medical Inc, initiated 2016-03-25, terminated 2016-05-06. It names 4 FDA 510(k) clearances: K151730, K141614, K132369 and 1 more. Product: 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.. Reason: 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..

Recalling firm: Hansen Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-25
Terminated: 2016-05-06
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

4 on FDA's record

K151730 — Magellan Robotic SystemHansen Medical, Inc.·cleared 2015-07-23
K141614 — MAGELLAN ROBOTIC SYSTEMHansen Medical·cleared 2014-08-07
K132369 — MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRHansen Medical, Inc.·cleared 2013-09-27
K111004 — HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETERHansen Medical, Inc.·cleared 2012-05-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.