Magellan Robotic Catheter Accessory Kits — Class II medical device recall Z-1564-2016
Terminated recall by Hansen Medical Inc, reported 2016-05-04, distributed nationwide. Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore
| Recall number | Z-1564-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hansen Medical Inc, Mountain View, CA, United States |
| Recall initiated | 2016-03-25 |
| Classified | 2016-04-25 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 8 kits |
| Lot numbers | 20151117 |
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 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1564-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.