Following the FDA communication to healthcare providers on June 2, Getinge reinforces guidance that no devices mentioned in the Field Safety Notice need to be returned.
On June 8, 2022, FDA revised their published press release, FDA Medical Device Recalls: Atrium Medical Corporation Recalls iCast Covered Stent (issued June 2, 2022), which classified a voluntary iCast Field Safety Notice (dated April 22, 2022) as a class 1 recall. In the first release, FDA stated “immediately stop using devices from affected lots.” However, this statement was inconsistent with the approved approach agreed upon by Getinge and FDA and has since been removed from the FDA press release to reflect the agreement that no devices need to be returned.
Getinge urges healthcare providers to read the FDA press release in its entirety and click on the link under “Product Lot Numbers: See recall database entry” to see “No Devices Need to Be Returned” in the Action section. Getinge has also created an FAQ on the product and FDA communication that is available on their website at this link.
All impacted customers have received communication from Getinge.
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