CLASS II Device recall · Reported 3 Oct 2012 · FDA Enforcement Report
Marathon Flow Directed Micro Catheter recalled by Micro Therapeutics Inc
Micro Therapeutics Inc is recalling Marathon Flow Directed Micro Catheter, distributed nationwide in the US. The recall was initiated on 23 Sep 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2472-2012
- FDA event ID
- 63188
- Recalling firm
- Micro Therapeutics Inc, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2011
- FDA classified
- 27 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 23 Sep 2011 | Recall initiated by company | |
| 27 Sep 2012 | Classified by FDA | +370 days |
| 3 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Product as listed by the FDA
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Where it was distributed
Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
Questions about this recall
Is Marathon Flow Directed Micro Catheter recalled?
Yes. Micro Therapeutics Inc recalled Marathon Flow Directed Micro Catheter on 23 Sep 2011. The recall is Class II and its status is Terminated. Recall number Z-2472-2012.
Why was it recalled?
The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Which lots are affected?
Lot # 9374210
Where was it sold?
Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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