Recall Z-1449-2015— Hansen Medical Inc
Class II · Terminated
Class II FDA medical device recall by Hansen Medical Inc, initiated 2015-03-18, terminated 2015-09-23. It names 3 FDA 510(k) clearances: K141614, K132369, K111004. Product: Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.. Reason: 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..
- Recalling firm
- Hansen Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-18
- Terminated
- 2015-09-23
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K141614 — MAGELLAN ROBOTIC SYSTEM
- K132369 — MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
- K111004 — HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
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 System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.