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SET Rotarex™S 6 F x 135 cm
Straub Medical AG · Model 80237 · UDI-DI 07640142811862
3
510(k) clearances
8,450
Adverse events (149 deaths)
34
Recalls
52
Facilities
Description
Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one sterile and one collecting bag.
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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.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.