Reported May 4, 2016 · Terminated
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan…
Hansen Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hansen Medical Inc · 800 E Middlefield Rd · Mountain View, CA · 94043-4030
Is this the product you have?
- Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80
- CardiologyThe 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
- Lot codes and dates
- Lot number 20151117
- Amount recalled
- 8 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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