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CUFF Aortic Root Exposure Device

CORCYM SRL · Model MI-CUFF-001 · UDI-DI 08022057015754

DWS Prescription

510(k) clearances

845

Adverse events (11 deaths)

Recalls

308

Facilities

Description

The CUFF device is a flexible surgical retractor designed for exposure and access purposes when inserted into the aortic root and used to retract aortic wall tissue. The device consists of a main body component with retraction wings which are two-tiered and extend laterally. The posterior aspect of the device has a stabilization flange along the inferior border. Two alignment suture eyelet holes can be found within the medial portion of the stabilization flange.

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.