# China NMPA Product Recall - Nickel-titanium alloy support system

Source: https://www.globalkeysolutions.net/records/china_product_recall/germany-optimed-medizinische-instrumente-gmbh/5c09411a-d0c9-4622-bdbc-d4d96b78b05a/
Source feed: China

> China NMPA product recall for Nickel-titanium alloy support system by Germany OptiMed Medizinische Instrumente GmbH published August 17, 2015. Recall level: Level II. OptiMed Medizinische Instrumente GmbH, a German medical device manufacturer, initiated a voluntary C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: OptiMed Medizinische Instrumente GmbH of Germany is voluntarily recalling its "nickel-titanium alloy support system".
- Company Name: Germany OptiMed Medizinische Instrumente GmbH
- Publication Date: 2015-08-17
- Product Name: Nickel-titanium alloy support system
- Recall Level: Level II
- Recall Reason: In an investigation based on product complaints, German stent manufacturer Optimed found that the 200mm long sinus-SuperFlex-635 stent often failed to deploy or was not fully deployed during placement. Incompletely deployed stents may require additional intervention from doctors, leading to stent elongation or breakage.
- Discovering Company: Germany OptiMed Medizinische Instrumente GmbH
- Manufacturing Company: Germany OptiMed Medizinische Instrumente GmbH
- Summary: OptiMed Medizinische Instrumente GmbH, a German medical device manufacturer, initiated a voluntary Class II recall of its Nickel-Titanium Alloy Stent Systems on August 17, 2015. This action, overseen by the National Medical Products Administration (NMPA) of China, addressed a critical issue where some of these vascular stents failed to deploy or fully deploy during implantation. The primary concern was that incomplete deployment could necessitate additional medical intervention, potentially leading to complications such as stent elongation or breakage during the procedure. An investigation, prompted by product complaints, confirmed the defect in specific models like the sinus-SuperFlex-635 stent of a certain length. This recall applied globally, with 98 units sold in China across specific affected batches, including Q007630 to Q015123 for model 8606-7200, and Q007618, Q008654 for model 8607-7200. In response, the NMPA mandated several actions. All units involved were required to immediately cease the sale and use of the affected stent systems and disseminate the recall notification to relevant distributors and end-users. Furthermore, the manufacturer, OptiMed, was responsible for collecting and ensuring the proper disposal of all unused recalled products. It was clarified that this issue only affects devices during the implantation phase and does not pose a risk to patients who have already successfully received the stent.

Company: https://www.globalkeysolutions.net/companies/germany-optimed-medizinische-instrumente-gmbh/2b6c0e27-1b7f-4a92-a282-dbcfe2b7ffcd/