Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Class I Recall Announced On Cardiosave Cardiac Assist Devices After Patient Death

Executive Summary

The recall, which is related to the risk fluid leaks may make the pumps shut down during use, comes only a few months after battery packs used in the pumps were recalled.

You may also be interested in...



Déjà Vu: Cardiosave Heart Device Racks Up Class I Recall Because Of Battery Problems (Again)

The US FDA says a recall of Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps is high-risk class I because the devices’ battery packs could fail. This isn’t the first time the pumps have been recalled because of battery troubles.

Medtronic Recalls Cardiac Defibrillators Due To Reduced Shock Potential

The device giant is recalling Cobalt and Crome defibrillators because they may deliver weaker shocks than intended.

US FDA Waits Until December To Enforce Unique Device Identifier Database For Low-Risk Devices

Agency won’t require manufacturers to submit class I devices to the database for an extra 75 days, and doesn't plan to enforce GUDID regulations against consumer health products. 

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

MT144854

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel