Hansen Medical Recalls Magellan Robotic Catheter Accessory Kits
Hansen Medical is recalling eight Magellan Robotic Catheter Accessory Kits because one batch was radiated below the required dose.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a deviation from the required radiation dose specification rather than a confirmed high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Hansen Medical Inc is recalling eight Magellan Robotic Catheter Accessory Kits, models MACC 50 and MACC80. These kits contain disposable components used with the Magellan System, a robotic control system for cardiology procedures that allows physicians to position catheters and guide wires while remaining away from the x-ray radiation source.
The recall was initiated after the firm's quarterly dose audit testing revealed that one batch, identified by lot number 20151117, was radiated below the augmented dose. Consequently, the product did not meet the required augmented dose of 28.4 kGy.
The affected kits were distributed nationwide to Ohio, Texas, Florida, California, and Georgia. Consumers and healthcare facilities should stop using these specific kits and contact Hansen Medical Inc for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Hansen Medical Inc
- Affected units
- 8
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)
- Lot number 20151117
Distribution
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