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RadAR EasyClik Vascular Compression Device
Semler Technologies, Inc. · Model 4185 · UDI-DI 10815614020118
DXC
Prescription
1
510(k) clearances
13,076
Adverse events (78 deaths)
26
Recalls
183
Facilities
Description
The RadAR EasyClik Vascular Compression Device Model 4185 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustments to permit patient blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patient hemostasis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4185 is natural in color.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-15 | Maquet Cardiovascular, LLC | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartst |
| 2025-08-15 | Maquet Cardiovascular, LLC | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartst |
| 2025-08-15 | Maquet Cardiovascular, LLC | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartst |
| 2025-07-01 | North American Rescue LLC. | Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device a |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2022-04-01 | Baxter Healthcare Corporation | There is a potential for foreign matter. |
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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.