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PressureMate Compression Assist Device
Semler Technologies, Inc. · Model 3201 · UDI-DI 10815614020064
DXC
Prescription
1
510(k) clearances
13,076
Adverse events (78 deaths)
26
Recalls
182
Facilities
Description
The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure with PressureMate in much the same way that they would when applying manual pressure. PressureMate is comprised of a non-sterile, reusable handle and a sterile, disposable SuperComfort Disc (Model 5303 or 5305) to aid in the practice of manual compression. The Model 3201 is of 23 oz. weighted stainless steel construction.
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.