medical Class II Updated 2021-09-08

Cardiovascular Systems Inc recalls STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25

Recalled Product

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

Hazard / Issue

There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot 340931
View official government recall

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