Generic Name: Control Unit For Intracardiac Pump Catheters Used For Circulatory Support — Trade Name: Impella Control Unit

Recall Summary Nippon Abiomed is recalling 745 IMPELLA Control Units used to operate heart support pumps due to cybersecurity vulnerabilities in the device's operating system. The affected units were shipped between January 2017 and January 2024 and have specific serial numbers listed in the recall notice. The company is voluntarily modifying these devices to address the identified security risks.

Recalling firm

Name of Manufacturer and Distributor: Nippon Abiomed Co., Ltd. — Address of Manufacturer and Distributor: 12F, Muromachi Higashi Mitsui Building, 2-2-1 Nihonbashi Muromachi, Chuo-ku, Tokyo —...

Product

Lot: 対象数量：745台 (*)(**) 出荷時期：平成29年1月19日～令和8年1月26日 (*)(**) 製品番号： 0042-0000-JP シリアル： IC4730, IC4732, IC5027, IC5029, IC5030, IC5031, IC5241, IC5243, IC5245, IC5246, IC5258, IC5259, IC5260, IC5261, IC5444, IC5445, IC5447, IC5478, IC5505, IC5506, IC5507, IC5508, IC5509, IC5510, IC5511, IC5512, IC5514, IC5515, IC5516, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5727, IC5728, IC5729, IC5730, IC5731, IC5732, IC5733, IC5734, IC5735, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, IC5864, IC5865, IC5866, IC5867, IC5868, IC5869, IC5928,...

Reason

We have identified cybersecurity risks related to the operating system installed on this product, and have therefore decided to voluntarily modify the product to address these risks.

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/4b964f81-7bd9-421c-bac5-8db5f14a8315