# China NMPA Product Recall - Detachable coil (Product name: Target)

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-neurovascular/b1584dfb-9957-4103-a90b-e8060c251909/
Source feed: China

> China NMPA product recall for Detachable coil (Product name: Target) by Stryker Neurovascular published July 15, 2016. Recall level: Level 3 Recall. Stryker Neurovascular, through its affiliate Stryker (Beijing) Medical Devices Co., Ltd., initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Neurovascular Active Recall of Releasable Coils (Trade Name: Target)
- Company Name: Stryker Neurovascular
- Publication Date: 2016-07-15
- Product Name: Detachable coil (Product name: Target)
- Recall Level: Level 3 Recall
- Recall Reason: In certain batches of Target Nano detachable coils, the anti-unwinding wire may break, causing the coil to stretch and unwind. This is because the coil is heated during electrical positioning testing. In the specific batches where equipment failure occurred, the coil was subjected to temperatures exceeding the melting point of the anti-unwinding wire, leading to its melting and breakage.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Neurovascular
- Summary: Stryker Neurovascular, through its affiliate Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its Target brand releasable coils, as reported by the National Medical Products Administration (NMPA) on July 15, 2016. The recall pertains to specific batches of Target Nano releasable coils.

The primary issue identified was the potential for the anti-unwinding wire within these coils to break, leading to the coil stretching and unwinding. Investigations revealed that during routine electrical positioning testing, these particular batches of coils were exposed to temperatures exceeding the melting point of the anti-unwinding wire. This excessive heat caused the wire to melt and subsequently break, compromising the device's integrity and function.

This recall action falls under the regulatory oversight of the NMPA, referencing registration number CFDA (Imported) No. 20133773913. Stryker Neurovascular is undertaking this voluntary recall to address the critical safety concern. Further details regarding the affected product models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form." The required action involves the retrieval of all affected units from the market to prevent potential patient harm resulting from device malfunction.

Company: https://www.globalkeysolutions.net/companies/stryker-neurovascular/dfa4048f-7c78-4970-ab1b-8a34319b33ba/