FDA Medical Device Recalls (openFDA)
Cardiovascular Systems Inc: DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
- Recall number
- Z-2385-2021
- Recalling firm
- Cardiovascular Systems Inc
- Product
- DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
- Status
- Terminated
- Initiated
- 2021-07-21
- Posted
- not on file
- Terminated
- 2026-03-18
- Reason
- 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.
- Root cause
- Process control
- Action
- The firm notified its consignees by letter on 07/1/2021. The notice explained the issue and requested the return of the affected products.
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
- Lot, serial or model codes
- Lot 340925
- 510(k) numbers
- ["K190634"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 3004742232
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28