The U.S. Food and Drug Administration has expanded a recall of Boston Scientific Corp's iCross coronary imaging catheters to include an additional 110,020 devices. The expansion also involves a new model of the catheters, Atlantis SR Pro2, primarily distributed outside the U.S.
Imaging catheters are used for ultrasound examination to determine whether a patient needs interventional coronary procedures. During the procedures, the catheter tips of the affected products can break inside of the patient causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.
The FDA has classified the recall as Class 1, the most serious type of recall, because use of the products carries a greater risk of serious health consequences or death. Last month, the company recalled 29,664 iCross catheters after receiving reports of the catheter tip detaching during procedures. For more information on earlier recall, click here.
Messa & Associates is experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of attorneys and medical experts has successfully pursued litigation and obtained verdicts and settlements for victims of medical device injuries. If you or a loved one has suffered serious injuries as a result of a recalled Boston Scientific iCross or Atlantis SR Pro2 catheters, please contact us at 1-877-MessaLaw.
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