Recalls for Instruments, Surgical, Cardiovascular

Due to a potential open seal in the sterile barrier packaging.

Sterility of device may be compromised due to breach of the chevron seal of the packaging

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 positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

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 positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

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 positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

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 positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

The sterile packaging has the potential to be compromised.

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

The device may not maintain water flow or temperature control.

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.

Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may

Medtronic has received reports regarding the Octopus Nuvo Tissue Stabilizer stating that during use, the collet (a component of the device that stabilizes the head link) fractured, thereby causing immediate separation of the head link from the shaft of the device. The resulting potential hazards are that fragments of the collet could fall into the patient's chest cavity and/or damage the heart ti

Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.

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.

Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.