Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Magellan Robotic Catheter Accessory Kits Recalled by Hansen Medical Inc Due to Firm's quarterly dose audit testing showed that one...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hansen Medical Inc directly.
Affected Products
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.
Quantity: 8 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hansen Medical Inc
Hansen Medical Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report