The FDA issued a press release on June 2, 2022 about the recent voluntary iCast Field Safety Notice, FDA Medical Device Recalls: Atrium Medical Corporation Recalls iCast Covered Stent. The original release classified the action as a Class 1 Recall and stated “Immediately stop using devices from affected lots.” This statement however, was inconsistent with the approved approach agreed upon by Getinge and FDA. It has since been removed from the FDA press release to reflect the agreement that no devices need to be returned.
Consequently, the original release led to subsequent media releases (and confusion) across the Hospital, Medical Device Industry, and Cardiovascular specialty press.
Per the FDA website (2014), “Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. A Class I Recall involves a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Per the FDA website (2018), “A medical device recall does not always mean that you must stop using the product or return it to the company.”
The FDA announced the classification; however, no devices were required to be removed from the market or returned to Getinge as part of the voluntary iCast Field Safety Notice.
The voluntary iCast Field Safety Notice addressed 75 complaints worldwide over a 3 year period, with ten of the complaints occurring in the US. None of the nine serious injuries occurred in the US. No deaths were reported related to the issue.
As agreed upon by the FDA, Getinge sent an urgent Field Safety Notice letter to all iCast customers who received product between December 31, 2018 and March 31, 2022.
The Field Safety Notice addressed 75 iCast and Advanta V12 complaints worldwide over a 3-year period and included additional instructions to consider prior to using the iCast device in off-label endovascular applications. The complaints were related the separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal as a result of fluid remaining in the balloon during removal, i.e. the balloon is not fully deflated when withdrawal is attempted.
The Field Safety Notice stated, “No devices need to be returned.”
An Atrium internal investigation identified that separations of the balloon or hub from the delivery catheter can occur if the balloon is not fully deflated and excessive force is used when removing the delivery catheter back through the sheath following stent deployment. This issue was found to most likely be the result of fluid remaining in the balloon during removal, i.e. the balloon is not fully deflated when withdrawal is attempted.
The additional instructions provided in the voluntary iCast Field Safety Notice reinforced to visually verify full deflation of the balloon via fluoroscopy before attempting to withdraw the delivery system.
The Field Safety Notice letter dated April 22, 2022 was sent to all US customers, who ordered iCast in the past three years. A second letter (June 3, 2022) was sent to note correction to the error in the FDA press release (June 2, 2022) to clarify that per the Field Safety Notice, no iCast product is required or requested to be returned to Getinge.
Getinge asks 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 find that “No Devices Need to Be Returned.” in the Action section.
On February 17, 2022, Getinge initiated a voluntary Medical Device Correction outside the US involving the Advanta V12 covered stent system (not available in the US), and on April 11, 2022 the Correction was expanded to include the iCast covered stent system, that is only marketed in the United States, due to an increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal.
A Field Safety Notice was sent to all Advanta V12 covered stent system customers. Additional instructions provided in the letter and now on labelling reinforces to visually verify full deflation of the balloon via fluoroscopy before attempting to withdraw the delivery system.
No Advanta V12 covered stents were required to be removed or returned from the market.
Yes. An updated letter was sent by Getinge to all US customers on June 9, 2022, which points to the April 22 letter and states: “Per the Field Safety Notice, no iCast product is required or requested to be returned to Getinge.”