Wirion Embolic Protection System recall
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Why was Wirion Embolic Protection System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: Lot 67876, UDI 011085000049188217221221100000067876 Lot 70309, UDI 011085000049188217230110100000070309 Lot 68706, UDI 011085000049188217221227100000068706 Lot 69543, UDI 011085000049188217230103100000069543 Lot 75758, UDI 011085000049188217230203100000075758 Lot 77278, UDI 011085000049188217230210100000077278 Lot 79994, UDI 011085000049188217230223100000079994 Lot 81252, UDI 011085000049188217230301100000081252 Lot 81986, UDI 011085000049188217230307100000081986 Lot 83080, UDI 011085000049188217230313100000083080 Lot 81998, UDI 011085000049188217230320100000081998 Lot 84796, UDI 011085000049188217230327100000084796 Lot 87909, UDI 011085000049188217230411100000087909 Lot 89035, UDI 011085000049188217230418100000089035 Lot 86622, UDI 011085000049188217230404100000086622 Lot 90096, UDI 011085000049188217230424100000090096 Lot 93949, UDI 011085000049188217230515100000093949 Lot 91603, UDI 011085000049188217230501100000091603 Lot 94895, UDI 011085000049188217230521100000094895 Lot 91939, UDI 011085000049188217230507100000091939 Lot 101930, UDI 011085000049188217230717100000101930
- Product
- WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
- Recalling firm
- Cardiovascular Systems Inc
- Quantity
- 711 units
- Distribution
- United States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS - Netherlands
- Recall date
- December 29, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)