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June 15, 2022
Getinge Clarifies FDA Medical Device Recall Communication Related to iCast
June 15, 2022—Getinge issue a clarification to an FDA Field Safety Notice related to the iCast cover stent (Atrium Medical Corporation, which was acquired by Getinge). The announcement reinforced the guidance that no devices mentioned in the Field Safety Notice need to be returned.
On June 8, the FDA issued a revision to its June 2 communication to health care providers, FDA Medical Device Recalls: Atrium Medical Corporation Recalls iCast Covered Stent, which classified the company’s April 22 voluntary iCast Field Safety Notice as a class 1 recall.
In the June 2 release, FDA stated, “Immediately stop using devices from affected lots.” However, Getinge advised that this statement was inconsistent with the approved approach agreed on 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.
In its advisory, Getinge urged health care providers to read the FDA press release in its entirety and click on the “Product Lot Numbers: See recall database entry” link, which states, “No devices need to be returned” in the Action section.
Getinge has also created a FAQ on the product and FDA communication, which is available on their website here. All impacted customers have received communication from Getinge, noted the company.
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