Product Recall

The FDA has designated Arrow International’s recall of two intra-aortic balloon pumps as a class 1 recall, the most serious kind.

The FDA has designated Medtronic’s recall of two parts of a ventricular assist device system as a class 1 recall, the most serious kind.

The FDA has designated Applied Medical’s recall of three latex balloon catheters as a class 1 recall, the most serious kind.

The FDA has designated Vascular Solutions’ recall of a dual lumen catheter used to rapidly deliver contrast material during angiographic studies as a class 1 recall, the most serious kind.

The FDA has designated Boston Scientific’s recall of angiographic catheters used for contrast agent delivery as a class 1 recall, the most serious kind.

The FDA has identified the recall of LeMaitre Vascular’s balloon embolectomy catheter as class 1, the most serious kind, due to risk for death or injury from balloon deflation failure.

The FDA has designated Abbott Vascular’s product recall of two coronary dilatation catheters as a class 1 recall, the most serious kind. The recall affects 13,891 devices distributed between August and January.

The FDA has designated Cook Medical’s product recall of a support catheter as a class 1 recall, the most serious kind. The recall affects 117 devices manufactured and distributed between Aug. 13 and Sept. 19.

The FDA has designated Abbott’s product recall of a circulatory support system as a Class 1 recall, the most serious kind. The recall affects 381 devices distributed between Nov. 22, 2017 and Aug. 6, 2019.

The FDA has designated Medtronic’s product recall of a guide catheter as a class 1 recall, the most serious kind. The recall affects 106,298 guide catheters manufactured and distributed between March 10, 2017, and April 4, 2019.