Generic Name: (1) Central Circulatory Arterio-venous Cannula (2) Femoral Arterio-venous Cannula — Trade Name: (1) Optisite — (2) Edwards Extracorporeal Circulation Cannula Nc
Recall Summary Edwards Lifesciences is recalling certain arterio-venous cannulas (Optisite and Edwards Extracorporeal Circulation Cannula models) used in heart surgery with heart-lung machines, because reinforcing wires approximately 3-4 mm long have been found protruding from the cannula tip. If used without being caught during pre-use inspection, these exposed wires could potentially cause tissue damage or destruction of red blood cells. No patient injuries have been reported to date, as healthcare workers discovered the wire exposure before use in all reported cases.
- Recalling firm
- Name of Manufacturer and Distributor: Edwards Lifesciences LLC — Address of Manufacturer and Distributor: 2-21-1 Kita-Shinjuku, Shinjuku-ku, Tokyo — License Type: Type I Medical Device...
- Product
- Lot: (1) 製造番号：OPTI16 出荷数量：2259 出荷時期：2022/12/02〜2025/04/30 製造ロット：131312, 131428, 131509, 131887, 132338, 132436, 132503, 132831, BSLC0040, BSLC0165, BSLC0320, BSLC1309, BSLC1468, BSLC1557, BSLC1682, BSLC1830, BSLC5302, BSLC5899, BSLC6166, BSLC8176, BSLC8659 製造番号：OPTI18 出荷数量：3794 出荷時期：2022/10/31〜2025/04/30 製造ロット：131289, 131311, 131317, 131433, 131435, 131513, 131554, 131606, 131737, 131909, 132175, 132201, 132366, 132395, 132416, 132430, 132435, 132505, 132958, BSLC0166, BSLC0661, BSLC0826, BSLC0887, BSLC0979, BSLC1114, BSLC1211, BSLC1308, BSLC1656, BSLC1660, BSLC3221, BSLC4153, BSLC4400,...
- Reason
- We have decided to voluntarily recall this product because there have been reports both domestically and internationally of a wire fragment approximately 3 to 4 mm in length protruding from the cannula body at the tip of the product.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cd09c06e-ba61-46fa-9d2d-5180ba2e9347