Cardiovascular Systems Inc FDA Recalls

3 recalls on file across devices, 1 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6Class INov 22, 2021Under certain circumstances, the WIRION filter assembly may	Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumsta	Class IDevices	Nov 22, 2021
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145Class IIJul 21, 2021There is a potential mislabeling of the OAD crown sizes: 1.	There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micr	Class IIDevices	Jul 21, 2021
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICROClass IIJul 21, 2021There is a potential mislabeling of the OAD crown sizes: 1.	There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micr	Class IIDevices	Jul 21, 2021