Boston Scientific has recalled all 21,000+ of its Fetch 2 aspiration catheters currently on the market after complaints began surfacing of shaft breakage during surgical procedures to remove coronary artery blood clots.
The US Food and Drug Administration (FDA) has classified the recall as Class 1, which their website describes as, “a situation in which there is a reasonable probability that the use of or exposure to [the] violative product will cause serious adverse health consequences or death.”
Boston Scientific has stated that patients who previously underwent procedures that utilized the defective medical device were not at any risk of adverse events. Even if the shaft broke during their procedure, the device was removed/retrieved and patients can expect no further complications.
The recalled catheters were manufactured between June 2014 and February 2016. Though they are now distributed by Boston Scientific, the devices are packaged and labeled as a Bayer Medical Care product. The Fetch 2 catheter profile was acquired by Boston Scientific in 2014.
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