{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "168102", "product_res_number": "Z-0390-2019", "event_date_initiated": "2018-09-05", "event_date_created": "2018-11-06", "recall_status": "Terminated", "event_date_terminated": "2021-02-11", "res_event_number": "81294", "product_code": "LIT", "k_numbers": [ "K121442" ], "product_description": "Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.", "code_info": "Catalog Number Lot Number Expiry Date 4400322X 82144115 2020-04-30; 4400602S 82144141 2020-05-31; 4400515X 82144947 2020-06-30; 4400308S 82148810 2020-11-30; and  4400508S 82148811 2020-11-30.", "firm_fei_number": "1016427", "recalling_firm": "Cordis Corporation", "address_1": "14201 NW 60th Ave", "city": "Miami Lakes", "state": "FL", "postal_code": "33014-2802", "additional_info_contact": "Cordis Endovascular Medical Information Line\n800-292-9332", "reason_for_recall": "Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).", "root_cause_description": "Process control", "action": "A letter dated September 5, 2018 was sent to all their customers by Cordis with the following request:\n1) Read this Urgent Medical Device Recall letter.\n2) Immediately check your inventory to confirm that you do not have any units\nfrom the affected lots in your possession. Identify and set aside any units\nfrom the identified lots in a manner that ensures the affected product will not\nbe used. Check all storage and usage locations.\n3) Review, complete, sign and return the enclosed Acknowledgement Form\ndirectly to Cordis at the fax number on the form.\n4) Return any affected product to the address listed on the form, with reference\nto your Customer Number which is listed on the form.\n5) Share this letter with others in your facility who need to be made aware of\nthis recall.\n6) Please contact any other facility that may have been sent the affected units\nof POWERFLEX PRO product from your facility. If any units of the affected\nlots are found to be at the other facility, please arrange the return of the\nunits.\n7) Maintain awareness of this notice until all affected product has been returned to Cordis\n8) Keep a copy of this notice with the affected product.\n\nFor any health care professional with medical concerns, please contact the\nCordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235,\nMonday through Friday from 9:00 AM to 5:00 PM EST.\nFor questions related to the recall that are not adequately addressed in this\nletter, please contact the market action team at:\nGMB-FieldCorrectiveAction@cardinalhealth.com\nFor questions related to the Acknowledgement Form and its return, please call (800)292-9332.", "product_quantity": "162 units total (74 units in USA)", "distribution_pattern": "Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.", "openfda": { "k_number": [ "K882925", "K940063", "K080925", "K880298", "K910996", "K152080", "K894899", "K915895", "K142654", "K973563", "K102482", "K943298", "K844972", "K921254", "K905250", "K842556", "K133861", "K930745", "K201333", "K942400", "K905698", "K173515", "K163231", "K103354", "K132020", "K945465", "K162350", "K933236", "K071042", "K173894", "K131199", "K854319", "K915347", "K851854", "K940868", "K883346", "K160013", "K911870", "K932537", "K911639", "K935501", "K000570", "K881088", "K981407", "K112697", "K955886", "K882826", "K052757", "K993305", "K843501", "K102705", "K123358", "K051916", "K000798", "K223177", "K901601", "K141521", "K121385", "K833248", "K900677", "K844913", "K102645", "K942635", "K230191", "K170193", "K242419", "K041293", "K181529", "K121265", "K970725", "K920547", "K830733", "K221414", "K222065", "K942293", "K103751", "K230263", "K964881", "K993639", "K923826", "K080982", "K960517", "K122379", "K113681", "K911203", 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"1028232" ], "device_name": "Catheter, Angioplasty, Peripheral, Transluminal", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }