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U.S. Department of Health and Human Services

Medical Devices

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Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters

Recall Class: Class I

Date Recall Initiated: March 28, 2011

Product(s): iCross and Atlantis A Pro2, 40 Mhz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, all lots.

110,020 devices are subject to this recall. iCross is marketed within the United States and its territories. Atlantis SR Pro2 is distributed outside the U.S.

Boston Scientific Corporation notified customers by letter on May 27, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were instructed to discontinue use and return all products to Boston Scientific.

Reason for Recall: The catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.

Use: The Boston Scientific iCross and Atlantis A SR Pro2 coronary imaging catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is used on patients who are candidates for transluminal coronary interventional procedures.

Recalling Firm:
Boston Scientific Corporation
1 Scimed Place
Maple Grove, MN 55311

Public Contact:
Boston Scientific Maple Grove Complaint Call Center: 1-800-811-3211. Or, Brent Hathcock, Field Action Team Lead at hathcocb@bsci.com.

FDA District: Minneapolis

FDA Comments:

Boston Scientific is advising customers to immediately discontinue use of any affected product and return all products to Boston Scientific.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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