Recall Z-0394-2022— Cardiovascular Systems Inc
Class I · Terminated
Class I FDA medical device recall by Cardiovascular Systems Inc, initiated 2021-11-22, terminated 2023-08-31. It names one FDA 510(k) clearance: K210282. Product: WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6. Reason: 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..
- Recalling firm
- Cardiovascular Systems Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-11-22
- Terminated
- 2023-08-31
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.