FDA Recalls IVUS Catheters

June 2011

The FDA issued a Class 1 recall of intravascular ultrasound (IVUS) catheters after reports of injuries surfaced. Just following a voluntary recall of almost 30,000 iCross catheters in late May, Boston Scientific is now expanding its recall to include Atlantis ASR Pro2 as well.

The recalls have been issued, because the tips of the catheters can easily break while inside the patient. Once broken, the tips can cause serious injury – tissue injury, blood vessel injury, heart attack, and other serious health risks that can require additional surgery.

Class 1 recalls are among the most serious types of recalls and are issued only in cases where using a product will likely result in the serious injury or death of a patient. iCross and Atlantis ASR Pro2 catheter users are strongly recommended to discontinue use of the product immediately. Those who are unsure if they are using either product should consult their healthcare provider.

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