{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "93235", "product_res_number": "Z-0287-2011", "event_date_initiated": "2010-05-13", "event_date_posted": "2010-11-02", "recall_status": "Terminated", "event_date_terminated": "2012-05-10", "res_event_number": "56324", "product_code": "DTB", "product_description": "enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.", "code_info": "serial numbers: 123070, 123072, 123073, 123075 thru 123092, 123094, 123095, 123097 thru 123104, 123431, 123432, 123433.", "firm_fei_number": "2183787", "recalling_firm": "Greatbatch Medical", "address_1": "2300 Berkshire Lane North", "city": "Minneapolis", "state": "MN", "postal_code": "55441", "additional_info_contact": "612-559-2613", "reason_for_recall": "The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.", "root_cause_description": "Employee error", "action": "Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor. The letter described the problem and product involved, and gave the action required which included:\n1) immediately discontinue distribution of the units and return any unused units to Greatbatch Medical.\n2) Reconcile medical recordsbetween BSC and Greatbatch Medical to confirm implant data\n3) Confirm pulse generator type (bipoloar, unipolar, or unknown) used with each serial number listed\nGreatbatch will work with customers to contact physicians as necessary regarding patient monitoring. Greatbatch Medical can be contacted at 763-951-8312.", "product_quantity": "34", "distribution_pattern": "Worldwide Distribution: to USA and Europe, through distributor in MN.", "openfda": { "k_number": [ "K833824", "K911273", "K853914", "K853521", "K780246", "K954610", "K823893", "K862276", "K791732", "K931411", "K844266", "K891905", "K760443", "K912235", "K770195", "K903948", "K813135", "K790462", "K782004", "K810399", "K890045", "K800349", "K922042", "K993448", "K981083", "K883203", "K791377", "K850065", "K851731", "K854069", "K864564", "K843707", "K864618", "K862052", "K823508", "K792301", "K834431", "K912464", "K844261", "K962036", "K802413", "K823892", "K854071", "K854963", "K875100", "K820262", "K890411", "K903221", "K900645", "K820767", "K853221", "K811539", "K903928", "K810582", "K864326", "K812989", "K951858", "K854405", "K791378", "K864738", "K771566", "K853520", "K823890", "K910609", "K770285", "K833108", "K862257", "K905182", "K860547", "K831436", "K893041", "K883602", 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