Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 4, 2016
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.
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.
Hansen Medical Inc recalled Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology… - a moderate-severity action.
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology… was recalled by Hansen Medical Inc in May 4, 2016. Reason: Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore…. Check the official notice for the remedy. Verify recall #Z-1564-2016 with the FDA Devices before acting.
The recall
Hansen Medical Inc issued this moderate-severity FDA Devices recall-Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore….
- Moderate
- severity level
- Class II
- classification
- May 4, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1564-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1564-2016) was formally reported on May 4, 2016, with the manufacturer initiating the action on March 25, 2016. 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 8 kits.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide Distribution to OH, TX. FL, CA and GA.. 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
8 kits
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1564-2016 |
| Date reported | May 4, 2016 |
| Date initiated | March 25, 2016 |
| Recalling firm | Hansen Medical Inc |
| Firm location | Mountain View, CA |
| Affected scope | 8 kits |
| Distribution | Nationwide Distribution to OH, TX. FL, CA and GA. |
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-1564-2016) 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 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.. Recalled by Hansen Medical Inc. Units affected: 8 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1564-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to OH, TX. FL, CA and GA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1564-2016) 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 May 4, 2016. 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.