FDA Alerts the Public About Johnson & Johnson SubsidiaryAbiomedNew Safety Risks Found in ABIOMED's Impella Controller (AIC) and Johnson & Johnson Required to Take ActionUpdateAll Impella Controller (AIC) User Manuals.Impella Controller (AIC)Display patient data when using the Impella series of heart pumps to provide mechanical circulatory support.Currently problematicThe Impella Controller (AIC) does not require a product recall, only an update to the instructions for use.
Johnson & Johnson DiscoveryImpella Controller (AIC)Presence of cardiac pump recognition障碍 (i.e., the device interface does not display故障 warnings)), this issue may occurDuring: Console switching process and surgical initiation phase.
Clinical Risk
Resulting in inadequate hemodynamic support
Increased Risk for Cardiogenic Shock Patients: Prolonged Duration of Inadequate Support May Lead toFatal Injury
So far, the issue has resulted in 3 deaths.
Johnson & Johnson's Preliminary Solutions- Console Switching Operation: If the pump switches to the new console and the interface in the figure below remains unresponsive for more than 20 seconds
Immediately switch the pump back to the original console to maintain patient support.
If the original console reports an error, activate the backup console.
- The console must be restarted from the interface shown in the figure below before reconnecting the pump body.
Surgical Start Operation: After connecting to the pump, the interface shown in Figure 2 remains for 20 seconds without transitioning to the "Detect Impella" state.
Restart the current console or switch to the backup console
Johnson & Johnson's Response to the IssueThe complaint analysis from January 2021 to May 2025 shows that the incidence of this issue is only 0.02%. In consideration of patient safety, we have issued a risk control guideline to customers in the United States, and the global notification will be executed in accordance with local regulations. According to the instructions for use, hospitals should always have a backup AIC console available.It is emphasized at the same time: this is not a product withdrawal.AIC and Impella pumps continue to be sold and serve clinical treatments. Providing standardized operation training for medical staff to improve patient outcomes remains our top priority, as we are always committed to offering safe and effective life support technologies for patients worldwide.ImpellaJohnson & Johnson spent $16.6 billion on acquisitions in 2022Abiomed。Impella is currently the most commercially successful interventional cardiac pump and the only FDA-approved interventional cardiac pump on the market. Last yearAbiomed Revenue$1.496 billion, a year-on-year increase of 14.5%.At the beginning of this year, the FDA issued a Class I recall for two series of products, Impella RP (SmartAssist) and Impella RP Flex (SmartAssistant). Reason for recall: "During the insertion, adjustment, or removal of a guidewire or other medical device, its tip may come into contact with the Impella pump body, posing a risk of damaging the optical sensor, causing the pump to pause or shut down permanently. Such failures may trigger alarms and result in the loss of some cardiac and blood pressure monitoring data." This recall only involves updating the instructions and does not involve product recalls.Due to the complex design and craftsmanship of interventional cardiac pumps, maintaining consistently stable product quality requires continuous optimization of the product (including updates to the user manual).
