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Diamondback Peripheral
Cardiovascular Systems, Inc. · Model DBP-CART-150SOL200 · UDI-DI 10852528005992
MCW
Prescription
10
510(k) clearances
8,450
Adverse events (149 deaths)
34
Recalls
52
Facilities
Description
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft, 120krpm High Speed, 90krpm Medium Speed, 60krpm Low Speed
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-05 | Bard Peripheral Vascular Inc | Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected |
| 2024-11-25 | Angiodynamics, Inc. | Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode. |
| 2024-11-25 | Spectranetics Corporation | Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. |
| 2023-11-15 | Spectranetics Corporation | Incorrect product labeling. Exterior product box label does not match internal pouch label. |
| 2022-02-04 | ev3 Inc. | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. |
| 2022-02-04 | ev3 Inc. | The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. |
| 2021-12-06 | ev3 Inc. | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. |
| 2021-12-06 | ev3 Inc. | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. |
| 2021-07-21 | Cardiovascular Systems Inc | 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. |
| 2021-07-21 | Cardiovascular Systems Inc | 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. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.