Home › Device types › MCW
Catheter, Peripheral, Atherectomy
FDA product code MCW · Class 2 · Cardiovascular
347
Registered devices
8,593
Adverse events
34
Recalls
146
510(k) clearances
Devices with this code
ZILIENT — Cardiovascular Systems, Inc.Stealth — Cardiovascular Systems, Inc.Rotarex™S 8 F x 110 cm — Straub Medical AGStealth — Cardiovascular Systems, Inc.SilverHawk — Covidien LPSET Rotarex™S 8 F x 110 cm — Straub Medical AGHawkOne™ — Covidien LPJETSTREAM™ PVCN100 — BOSTON SCIENTIFIC CORPORATIONStealth — Cardiovascular Systems, Inc.Phoenix 1.8mm x 130cm 5F Atherectomy System — Volcano Atheromed, Inc.Pantheris — Zylox-Tonbridge Medical Technology Co., Ltd.Stealth — Cardiovascular Systems, Inc.Phoenix 2.2mm x 149cm 6F Atherectomy System — Volcano Atheromed, Inc.Auryon Atherectomy Catheter — EXIMO MEDICAL LTDDiamondback Peripheral — Cardiovascular Systems, Inc.Auryon Atherectomy Catheter — EXIMO MEDICAL LTDZILIENT — Cardiovascular Systems, Inc.HawkOne™ — Covidien LPSilverHawk™ — MEDTRONIC, INC.Turbo-Power Laser Atherectomy Catheter — Spectranetics CorporationRevolution Peripheral Atherectomy System — Rex Medical, Inc.Turbo-Elite Laser Atherectomy Catheter — Spectranetics CorporationAuryon Atherectomy Catheter — EXIMO MEDICAL LTDJETSTREAM XC — Bayer Healthcare LLC
Recent 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 |
| 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted. |
| 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 Activatio |
| 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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