Reported Dec 17, 2014 · Terminated
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in…
Concentric Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Concentric Medical Inc · 301 E Evelyn Ave · Mountain View, CA · 94041-1530
Is this the product you have?
- Distal Access CatheterModel
- Numbers90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems
- Lot codes and dates
- Lot Number 3600709-2014
- Lot Number 3576705-2014
- Lot Number 3598008-2014
- Lot Number 3595108-2014
- Lot Number 3605009-2014
- Lot Number 3601709-2014
- Lot Number 3602909-2014
- Lot Number 3558302-2014
- Amount recalled
- 87 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
This product could cause temporary or reversible health problems — stop using it.
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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