Medical Device Alerts issued in May 2017

Alerts were issued about LIFEPAK 1000 automatic external defibrillators, Mitroflow LX (sizes 19mm and 21mm) biological replacement pericardial aortic heart valves, and Accu-Chek Insight insulin pumps.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 21 June 2017

• Therapeutic area: Cardiovascular disease and lipidology and Endocrinology, diabetology and metabolism

In this monthly update, we will be highlighting selected Medical Device Alerts that have been issued recently by MHRA. Be aware of any device issues affecting your patients or your practice and find out whether any recommended actions apply to you. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

In May 2017, Medical Device Alerts were issued by MHRA about:

• all LIFEPAK 1000 automatic external defibrillators (AEDs), manufactured by Physio-control: risk of device shutting down unexpectedly during patient treatment and possible failure to deliver therapy
• biological replacement pericardial aortic heart valves; Mitroflow LX (sizes 19mm and 21mm), manufactured by LivaNova: risk of early structural valve deterioration
• all Accu-Chek® Insight insulin pumps, manufactured by Roche: updated information for battery management

Article citation: Drug Safety Update volume 10 issue 11, June 2017: 6.

Published 21 June 2017