{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "43970", "product_res_number": "Z-0410-06", "event_date_initiated": "2005-12-07", "event_date_posted": "2006-02-01", "recall_status": "Terminated", "event_date_terminated": "2007-08-10", "res_event_number": "34504", "product_code": "LIT", "k_numbers": [ "K052038" ], "pma_numbers": [ "P950020" ], "product_description": "The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty (PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure.", "code_info": "Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554", "firm_fei_number": "2024805", "recalling_firm": "Boston Scientific Corporation", "address_1": "3574 Ruffin Rd", "city": "San Diego", "state": "CA", "postal_code": "92123-2597", "additional_info_contact": "Abe Mathews\n408-895-3981", "reason_for_recall": "The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.", "root_cause_description": "Other", "action": "All affected direct accounts will be given notification by Overnight mail. A 100% of the total number of customer are to be contacted.", "product_quantity": "individual qty in US:376, Worldwide distribution pending.", "distribution_pattern": "Nationwide plus Argentina Austria Belgium Brunei Canada Chile China Colombia Czech Republic Denmark Finland France Germany Great Britain Hong Kong Hungary India Indonesia Ireland Israel Italy Latvia Lebanon Luxembourg Macau Malaysia Mexico Netherlands Norway Poland Portugal Puerto Rico Saudi Arabia. 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