Class 2 Device Recall Boston Scientific /Microvasive

• Date Initiated by Firm: April 29, 2003
• Date Posted: May 15, 2003
• Recall Status: Terminated on March 11, 2004
• Recall Number: Z-0831-03
• Recall Event ID: 26206
• Product Classification: Catheter, Angioplasty, Peripheral, Transluminal - Product Code LIT
• Product: MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 14mm/42 Fr
• Code Information: Catalog Number: 8914 Lot Number: 5465675
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Boston Scientific Place; Natick MA 01760
• For Additional Information Contact: Robert T. Miragliulo; 508-652-5186
• Manufacturer Reason for Recall: Catheter may be mislabeled
• FDA Determined Cause: Other
• Action: The firm notified each direct account by letter on 4/29/03 and, via letters of July 3 and July 11, 2003, extended the recall to three additional sizes of the catheter . Users were requested to check inventory, return the products to Boston Scientific and to reply regarding receipt of recall notification and the return of products.
• Quantity in Commerce: 9 units
• Distribution: CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.