Reported Dec 29, 2021 · Terminated
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Cardiovascular Systems Inc.
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: Cardiovascular Systems Inc · 1225 Old Highway 8 NW · Saint Paul, MN · 55112-6416
Is this the product you have?
- WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 Lot 67876, UDI 011085000049188217221221100000067876 2 Lot 70309, UDI 011085000049188217230110100000070309 3 Lot 68706, UDI 011085000049188217221227100000068706 4 Lot 69543, UDI 011085000049188217230103100000069543 5 Lot 75758, UDI 011085000049188217230203100000075758 6 Lot 77278, UDI 011085000049188217230210100000077278 7 Lot 79994, UDI 011085000049188217230223100000079994 8 Lot 81252, UDI 011085000049188217230301100000081252 9 Lot 81986, UDI 011085000049188217230307100000081986 10 Lot 83080, UDI 011085000049188217230313100000083080 11 Lot 81998, UDI 011085000049188217230320100000081998 12 Lot 84796, UDI 011085000049188217230327100000084796 13 Lot 87909, UDI 011085000049188217230411100000087909 14 Lot 89035, UDI 011085000049188217230418100000089035 15 Lot 86622, UDI 011085000049188217230404100000086622 16 Lot 90096, UDI 011085000049188217230424100000090096 17 Lot 93949, UDI 011085000049188217230515100000093949 18 Lot 91603, UDI 011085000049188217230501100000091603 19 Lot 94895, UDI 011085000049188217230521100000094895 20 Lot 91939, UDI 011085000049188217230507100000091939 - Amount recalled
- 711 units
Where it was sold
Why it was recalled
Stop using this product now
Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
Using this product could cause serious injury, illness or death — stop using it now.
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