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TIE Intracorporeal Knot Placement Assist and COLLAR Papillary Muscle Exposure

CORCYM SRL · Model MI-COTIE-001 · UDI-DI 08022057015860

DWS Prescription

510(k) clearances

848

Adverse events (12 deaths)

Recalls

308

Facilities

Description

The TIE device is a tourniquet-style surgical instrument used to control the target location of knot seating during precise suture knot tying and delivery applications. The COLLAR device is a flexible surgical retractor designed to retract valve leaflet tissue when inserted within the valve annulus. The device consists of a main body component which extends laterally to become the retraction wings. The distal tips of the retraction wings are bifurcated for additional tissue traction. The posterior aspect of the device has a stiffening rib along the superior border and a stabilization flange along the inferior border. The COLLAR device is available in 2 sizes (small and large) which are packaged together in a disposable set with the TIE device.

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.