Instruments, Surgical, Cardiovascular

Introducer Needle

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

Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads.

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

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and ch

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.

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

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.

ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

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.

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

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.

Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardi

The sterile packaging has the potential to be compromised.

Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

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

Teleflex Medical Disposable Aortic Punch, in the following sizes:

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

The Hemotherm 400CE 115v, containing power board p/n 39945

The device may not maintain water flow or temperature control.