Reported Nov 16, 2016 · Terminated
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended…
Micro Therapeutics Inc., dba Ev3 Neurovascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Micro Therapeutics Inc, Dba Ev3 Neurovascular · 9775 Toledo Way · Irvine, CA · 92618-1811
Is this the product you have?
- Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow
- Directed Micro Catheter Marathon FlowThe device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media
- UltraFlow HPC FlowThe device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
- Lot codes and dates
- Additional Lots
1,790 of 1,790 codes
9946730996099999659689974493A004327A011297A016502A0245919952156996101699659709975117A004329A011515A016504A0245949952519996129799659809975118A004435A011522A016507A0248939952892996130899659839976018A004436A011731A016510A0248949953171996131399659849976024A004437A011735A016632A0248969953177996324599660229976049A004535A011818A017149A0251309953699996324799662009976052A004537A011845A017150A0258579953892996324999662039976055
A335134A335148A33515499524039952144995075499507319950392995145199500079951453A076257A336031A336033A335161A335378A335379A335404A335541A335542A336029A336036A336354A336688A336706A337379A338056A338065A338068A086973
- Amount recalled
- 66,429 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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