Administrative Guidance against K.K. Sanmedeikaruji Shu Yan Jiu Suo
Action summary
- Company
- K.K. Sanmedeikaruji Shu Yan Jiu SuoRomanizedOriginal: 株式会社サンメディカル技術研究所Corporate Number: 9100001025944
- Governing law
- 医薬品医療機器等法医薬品医療機器等法
- Action type
- Administrative Guidance行政指導
- Action date
- August 3, 2020
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Regarding the 'Implantable Assist Artificial Heart EVAHEART' manufactured and sold by Sun Medical Technology Research Institute Co., Ltd., a Class I voluntary recall has been ongoing since September 2019. A death occurred on July 14, 2020, in a patient whose overall condition was poor and for whom the device could not be replaced.
Show original Japanese text
株式会社サンメディカル技術研究所が製造販売する「植込み型補助人工心臓EVAHEART」については、令和元年９月より自主回収（クラスⅠ）を実施しているところですが、全身状態が悪く当該製品の交換ができなかった患者において、令和２年７月14日に死亡事例が発生した。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- K.K. Sanmedeikaruji Shu Yan Jiu Suo Romanized
- Japanese name
- 株式会社サンメディカル技術研究所
- Corporate Number
- 9100001025944
- Registered address
- 長野県諏訪市大字四賀２９９０番地
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.