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CompressAR Large Comfort Disc

Semler Technologies, Inc. · Model 5187 · UDI-DI 10815614020194

DWS Prescription

510(k) clearances

848

Adverse events (12 deaths)

Recalls

308

Facilities

Description

The CompressAR Large Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5187 is a large, round disc with upturned edges (2" dia.).

Recalls

Date	Firm	Reason
2025-03-27	Galt Medical Corporation	Due to a potential open seal in the sterile barrier packaging.
2023-07-24	Cook Vandergrift, Inc.	Sterility of device may be compromised due to breach of the chevron seal of the packaging
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2023-06-28	Maquet Cardiovascular, LLC	The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positi
2022-02-09	Maquet Cardiovascular, LLC	Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
2020-02-06	Deroyal Industries, Inc. Lafollette	The sterile packaging has the potential to be compromised.
2020-01-13	TELEFLEX MEDICAL INC	There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
2020-01-13	TELEFLEX MEDICAL INC	There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

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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.