Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 22, 2015
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
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 op…
Hansen Medical Inc recalled Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control syst… - a moderate-severity action.
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control syst… was recalled by Hansen Medical Inc in April 22, 2015. Reason: Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 1113…. Check the official notice for the remedy. Verify recall #Z-1449-2015 with the FDA Devices before acting.
The recall
Hansen Medical Inc issued this moderate-severity FDA Devices recall-Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 1113….
- Moderate
- severity level
- Class II
- classification
- April 22, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1449-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1449-2015) was formally reported on April 22, 2015, with the manufacturer initiating the action on March 18, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Hansen Medical Inc is listed as the recalling firm, operating out of Mountain View, CA. Federal records list the affected scope as 19 total installed systems.
The documented reason for this recall is: 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 cath… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19 total installed systems
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1449-2015 |
| Date reported | April 22, 2015 |
| Date initiated | March 18, 2015 |
| Recalling firm | Hansen Medical Inc |
| Firm location | Mountain View, CA |
| Affected scope | 19 total installed systems |
| Distribution | Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1449-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.. Recalled by Hansen Medical Inc. Units affected: 19 total installed systems.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1449-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1449-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 22, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.