Generic Name: Implantable Pain Relief Stimulator — Brand Name: Medtronic Vanta Pc
- Recalling firm
- Name of Manufacturer/Distributor: Medtronic Japan, Ltd. — Address of Manufacturer/Distributor: 1-2-70 Konan, Minato-ku, Tokyo — License Type: Class I Medical Device Manufacturer/Distributor —...
- Product
- Lot: モデル番号：977006 対象シリアル： NMS512927H NMS512928H NMS512929H NMS512931H NMS512932H NMS512934H NMS512935H NMS512936H NMS512937H NMS512938H NMS512939H NMS512940H NMS512942H NMS512943H NMS513132H NMS513133H NMS513222H NMS514322H NMS514324H NMS514325H NMS514326H NMS514328H NMS514330H NMS514334H NMS514629H NMS514630H NMS514631H NMS514632H NMS514633H NMS514854H NMS514855H NMS514882H NMS514892H NMS514937H NMS514942H NMS514948H 出荷数量：36台 対象シリアルの出荷日：令和6年11月19日から令和7年8月14日. Use: 本品は脊髄硬膜外腔に電気刺激を与え、各種疾患に伴う慢性難治性疼痛を緩和することを目的として使用する。 対象となる疼痛は薬物療法、神経ブロック等によって十分な鎮痛又は除痛効果が得られない、体幹及び四肢の慢...
- Reason
- In Medtronic Vanta PC implantable nerve stimulators, there is a rare risk of a malfunction that may prevent communication with the clinician programmer (Note 1) and the patient programmer (Note 2). To address this issue, the overseas manufacturer has developed and released an updated firmware version and has begun manufacturing Vanta PC units equipped with this updated firmware. Consequently, we are conducting a voluntary recall of unused inventory of Vanta PC units equipped with the older firmware version. Please note that for products already implanted, no special action is required, and...
- 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/f0ecd4a4-d0a5-4686-8784-da0b1b534e5c