Home › Biorep Technologies, Inc. › DeTACH - Detachable Aortic Cross Clamp Head - Large

DeTACH - Detachable Aortic Cross Clamp Head - Large

Biorep Technologies, Inc. · Model 1.0 · UDI-DI 00858733006239

DXC Prescription

510(k) clearances

12,981

Adverse events (78 deaths)

Recalls

182

Facilities

Description

The DeTACH Detachable Aortic Cross Clamp Head device is a detachable cross clamp head used for temporary or partial occlusion of blood vessels during cardiovascular procedures. The jaws of the device are covered with autraumatic flexible tissue-engagement pads. The upper jaw pivots independently in relation to the pivot jaw actuator arm and the lower/fixed jaw to allow for parralel closure at distances between 5mm and less. The clamp head also incorporates a cam style locking mechanism to lock the jaws in the closed position after dethachment from the delivery device. The DeTACH Detachable Aortic Cross Clamp Head device is available in small, medium and large sizes (55mm, 65mm and 85mm tissue engagement pads respectively) which are packaged and distributed separately. The DeTACH Detachable Aortic Cross Clamp Head device utilizes the DeTACH Delivery Device

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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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.