WIRION Embolic Protection System Filter Withdrawal Difficulties
Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall mandates a minimum score of 4. The device is used in vascular intervention and failure during withdrawal could result in embolization and serious vascular injury. No illnesses or deaths are reported in the source text.
Plain-English summary
Cardiovascular Systems Inc is recalling WIRION Embolic Protection System devices (Model WRN-D6, 6Fr delivery catheter with filter and retrieval catheter) due to a defect affecting safe device withdrawal.
Under certain circumstances, the filter assembly may become difficult to withdraw from the patient during the procedure. When this occurs, the device may tear or separate, which can result in embolic material remaining in the blood vessels, potentially causing serious vascular complications.
Approximately 711 units were distributed across the United States and the Netherlands. Healthcare providers and facilities that have received affected lots should identify patients who received this device and consult the FDA and manufacturer guidance on appropriate clinical management.
Patients who received this device during interventional vascular procedures should contact their healthcare provider immediately to discuss any symptoms or concerns, and to determine if follow-up imaging or clinical evaluation is needed.
The recalled product
- Product
- WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
- Manufacturer
- Cardiovascular Systems Inc
- Hazard
- device-failure
- embolization
- tearing-separation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 38 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
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