—#99277

Product

Boston Scientific, Atlantis SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 94538 The intended use as stated in Japan Shonin 21200BZY00484000: This product is an imaging catheter with built-in ultrasonic transducer that sends ultrasound waves inside the blood vessel to perform B-mode ultrasonagraphy. The indications for use as stated in the 510(k) and DFU 90606867: The Atlantis coronary catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular Ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K050577, K063312
Affected lot / code info: All lots are impacted

Why it was recalled

Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement.

Root cause (FDA determination)

Process design

Action the firm took

Boston Scientific " Important Customer Notification" letters dated March 14, 2011 were hand delivered to customers by Boston Scientific sales representatives starting on March 28th, 2011. The sales representatives verbally reviewed information. A tracking log will be maintained document completion of the customer notifications. The letter described the product, problem and possible root cause as well as one corrective action, a change in sterilization method from Gamma to E-beam implementation. Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter dated May 26, 2011, to all affected customers. Customers were instructed to Identify and discontinue use of any affected product within their inventory and to segregate it immediately and return it to Boston Scientific

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Japan, Trinidad, Tobago, and American Virgin Islands.

Timeline

Recall initiated: 2011-03-28
Posted by FDA: 2011-06-10
Terminated: 2012-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.