Medtronic initiates worldwide recall of StrataMR valve: 5 things to know

 Medtronic on Thursday launched a voluntary recall of its StrataMR valve, reports the Star Tribune.

Here are five things to know.

1. The StrataMR device is used to manage the buildup of cerebrospinal fluid that surrounds the brain.

2. The company issued the worldwide recall after receiving numerous reports that an issue with the device can cause "underdrainage" after implantation, according to a product alert from Medtronic.

3. One patient death may also be related to the defect, although it has not been confirmed, according to Star Tribune.

4. The recall affects 2,622 StrataMR valves manufactured between October 2015 and November 2016.

5. Medtronic said physicians should stop using the StrataMR valve and return all unused devices to the company.

More articles on supply chain:

Arizona law OKs off-label drug promotion, contradicts FDA rules
Mallinckrodt drops out of PhRMA
Cardinal Health looks to acquire Medtronic's medical supplies unit for $6B

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Articles We Think You'll Like

 

Featured Whitepapers

Featured Webinars