Magellan Robotic System — Class II medical device recall Z-1449-2015
Terminated recall by Hansen Medical Inc, reported 2015-04-22. Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132
| Recall number | Z-1449-2015 |
|---|---|
| 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 | 2015-03-18 |
| Classified | 2015-04-15 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2015-09-23 |
| Countries outside the US | AU, DE, FR, GB, IT, SA |
| Quantity | 19 installed |
| Model numbers | 11132, 11139 |
Product
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Reason for recall
Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.
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-1449-2015. 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.