Device alerts

They are equivalent to the MDA 'immediate action' category. They remain valid unless they are updated or withdrawn. They are reviewed once they are five years old (and subsequently every five years) and the lists on this website are amended accordingly.

Latest Device alerts

• 14 May 2002| DA 2002(05) - TALENT stent graft system: connector bar and stent spring fracture after implantation

  Fracture of the nitinol connector bar and stent springs within the TALENT stent graft following implantation (time of occurrence unknown).

• 02 May 2002| DA 2002(02) AMENDED - Use of Angioplasty Balloon Catheters

  Failure to follow the manufacturer's instructions for use could lead to serious patient injury.

• 26 Sep 2001| DA 2001(06) - Hylamer Polyethylene Components Sterilised by Gamma-Irradiation in Air: 1. Hylamer Duraloc Acetabular Liners, 2. Hylamer Ogee Acetabular Cups, 3. Hylamer Global Shoulder Glenoid Components

  Poor clinical performance of some of the above joint replacement implant components, made from Hylamer polyethylene which has been sterilised by gamma-irradiation in air.

• 15 Jun 2001| DA 2001(04) - The Use of Central Intravenous Access in Neonatal Parenteral Feeding

  Long line catheters can migrate towards the heart wall during long term use causing cardiac tamponade with potentially fatal consequences.

• 11 Dec 2000| DA 2000(08) - Breast Implants: NovaGold™

  Recall of NovaGold™ breast implants.

• 11 Dec 2000| DA 2000(07) - Breast Implants: PIP Hydrogel®

  Voluntary recall of PIP Hydrogel® breast implants.

• 31 Jan 2000| DA 2000(01) - Silzone® Prosthetic Heart Valves and Annuloplasty Rings: Recall

  Recall of prosthetic heart valves and annuloplasty rings with Silzone[R] coated sewing cuffs due to high rate of paravalvular leak leading to valve explant.