{ "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": "191509", "product_res_number": "Z-0557-2022", "event_date_initiated": "2021-12-17", "event_date_posted": "2022-02-03", "recall_status": "Open, Classified", "res_event_number": "89418", "product_code": "LIT", "k_numbers": [ "K163231" ], "product_description": "Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US", "code_info": "UDI: 10884521812253, 07290016745047, 10884521812291\n\nFor CFN CH08-40-75US:\nGTIN\t Batch\n07290016745047\t21904374\n07290016745047\t21904432\n07290016745047\t22000673\n07290016745047\t22000709\n07290016745047\t22000817\n07290016745047\t22000880\n07290016745047\t22001030\n07290016745047\t22001061\n07290016745047\t22001191\n07290016745047\t22001310\n07290016745047\t22001417\n07290016745047\t22001448\n07290016745047\t22001728\n07290016745047\t22002086\n07290016745047\t22002088\n10884521812253\t22002498\n07290016745047\t22002583\n10884521812253\t22002603\n07290016745047\t22003037\n07290016745047\t22100003\n07290016745047\t22100321\n07290016745047\t22100322\n07290016745047\t22101089\n07290016745047\t22101090\n10884521812291\t22102189", "firm_fei_number": "1282497", "recalling_firm": "Covidien Llc", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "Customer Service\n800-962-9888", "reason_for_recall": "The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector\nsleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks\nassociated with surgical intervention, or delay to treatment/therapy.", "root_cause_description": "Under Investigation by firm", "action": "On December 17, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. \n\nPatient recommendation:\nContinue to monitor patients according to your hospital's patient management process.\n\nRequired Actions:\n1. Please immediately quarantine and discontinue use of the affected item code.\n2. Please return affected product as indicated below. All products from the affected item code and lots listed below must be returned.\n3. If you have distributed the products listed above, please promptly forward the information from this letter to those recipients.\n4. Please complete the Recalled Product Return Form even if you do not have inventory.\n\nIf you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.", "product_quantity": "1,994 devices", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.", "openfda": { "k_number": [ "K952063", "K180007", "K242419", "K953647", "K830733", "K803057", "K962945", "K843880", "K830608", "K902454", "K893411", "K052757", "K163231", "K093636", "K981906", "K862467", "K143036", "K972512", "K130911", "K260304", "K102645", "K813331", "K140351", "K960501", "K834220", "K833616", "K910995", "K971577", "K902091", "K142379", "K890405", "K152080", "K133861", "K152230", "K880158", "K843383", "K152887", "K112513", "K844972", "K003159", "K000570", "K221832", "K901767", "K924358", "K143041", "K953298", "K913391", "K192399", "K052038", 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