BD—Bard CONQUEST PTA Balloon Dilatation Catheters: Packaging May Contain Incorrect Size Balloon
October 14, 2020 | Risk Management News
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In an October 1, 2020, Urgent Medical Device Recall Notification letter submitted by an ECRI member hospital, BD states that the packaging for the above catheters may contain an incorrect size balloon. The inflation hub on the devices and the package labeling states that the balloon size is 6 x 40 mm; however, the product in the packaging was manufactured incorrectly with a 5 x 40 mm balloon. BD also states that unsuspected use of a PTA balloon that is smaller in diameter than expected could result in inconsequential prolongation of the existing procedure for repeated angioplasty using a larger diameter PTA balloon. BD further states that it has received one report of device malfunction related to this problem; however, the firm has received no reports of serious injury related to this problem. The manufacturer has not confirmed the...