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Control Unit (with cord) (Straub Medical®)

Straub Medical AG · Model Version 1.0 · UDI-DI 07640142810872

MCW Prescription

510(k) clearances

8,450

Adverse events (149 deaths)

Recalls

Facilities

Description

The control unit console contains the power supply, system controller, mode selectors, and has auditory and visual alarms to signify irregularities in the rotational speed. The control unit is designed for tabletop use outside the sterile field. The control unit is a part of the Straub Medical Drive System.

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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.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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Data 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.