# China NMPA Product Recall - Embolization devices, guidewires, floating microcatheters

Source: https://www.globalkeysolutions.net/records/china_product_recall/micro-therapeutics-inc-dba-ev3-neurovascular/dd3f79b1-b08f-40f6-941f-524a43e156c0/
Source feed: China

> China NMPA product recall for Embolization devices, guidewires, floating microcatheters by Micro Therapeutics Inc. dba ev3 Neurovascular published December 07, 2016. Recall level: Class I Recall. Covidien Medical Devices International Trading (Shanghai) Co., Ltd., the Chinese responsible unit fo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien International Trading (Shanghai) Co., Ltd. initiates voluntary recall of embolization devices, guidewires, and floating microcatheters.
- Company Name: Micro Therapeutics Inc. dba ev3 Neurovascular
- Publication Date: 2016-12-07
- Product Name: Embolization devices, guidewires, floating microcatheters
- Recall Level: Class I Recall
- Recall Reason: Medtronic is issuing this voluntary recall because it has discovered that the PTFE (polytetrafluoroethylene) coating on certain batches of embolization devices, guidewires, and floating microcatheters (manufactured between July 2014 and September 2016) may delaminate and detach, potentially leading to PTFE microparticles separating and entering the patient's bloodstream. PTFE in the bloodstream may not pose a danger until it reaches the acceptable quantity and size determined in simulated use testing; however, exceeding critical levels may cause patient injury. Related patient hazards may include, but are not limited to, intracranial edema, peripheral edema, incomplete treatment infection, local inflammatory response, systemic inflammatory response, ischemic stroke, cell lysis and necrosis, neurological dysfunction, organ dysfunction, shock, space-occupying lesions, thrombotic hemorrhage, and peripheral infarction.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Micro Therapeutics Inc. dba ev3 Neurovascular
- Summary: Covidien Medical Devices International Trading (Shanghai) Co., Ltd., the Chinese responsible unit for Medtronic, announced a voluntary Class I recall for specific embolization devices, guidewires, and floating microcatheters. This high-priority recall, initiated in October 2016 and published by the National Medical Products Administration (NMPA) in December 2016, addresses a significant safety concern. The core issue is the potential delamination and peeling of the polytetrafluoroethylene (PTFE) coating on affected products, manufactured between July 2014 and September 2016. This defect could result in PTFE microparticles detaching and entering a patient's bloodstream, posing a risk of serious adverse events. Potential patient injuries include, but are not limited to, intracranial edema, systemic inflammatory responses, ischemic stroke, organ dysfunction, and shock. Operating under the NMPA's regulatory guidance for medical device recalls, the company implemented a global corrective action. Distributors of the affected products were notified via customer letter to meticulously check their existing inventory. All identified units corresponding to the specified models and batch numbers were to be returned to Medtronic for proper disposal. Importantly, for products already implanted or used in patients, no immediate medical intervention or action was mandated, with patient care continuing under standard medical protocols. This recall underscores a commitment to product safety and compliance within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/micro-therapeutics-inc-dba-ev3-neurovascular/6f7ef542-0405-4c6a-839f-b164f7f30fac/