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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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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