| Developers: | Abiomed |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2025
Johnson & Johnson admits marriage in Impella heart pumps - cracks in them
At the end of September 2025, the US Food and Drug Administration (FDA) reported that Abiomed, part of Johnson & Johnson MedTech, has a defect in its heart support devices. The use of defective products can result in serious harm to the health of patients or even provoke death.
The notice says the issue is related to the Automated Impella Controller (AIC). It is the primary control interface for Impella catheter pumps designed to reduce stress on the left ventricle of the heart. Such devices support the operation of the circulatory system, giving the heart time to recover. The AIC allows you to monitor the operation of the pump and monitor alarms.
Johnson &
The revealed defect is manifested in damage to the purge retainer, including cracks. This can lead to errors, emergency alerts and potential interruptions in hemodynamic support. As a result, there is a risk of stopping the pump, which can provoke irreversible consequences for the patient's health or death. As of August 27, 2025, Abiomed reported five serious injuries to people due to the use of defective equipment. No deaths were recorded.
An analysis of 660 complaints from February 2022 to July 2024 showed that the probability of a problem is 0.61%. To eliminate the defect, changes will be made to the design of the devices.
 | Johnson & Johnson MedTech is starting a voluntary recall of a certain number of Impella automated controllers due to the need to change the design by adding one screw to the purge retainer, the manufacturer says.[1] |  |
Identification in devices of marriage, because of which people die
On July 1, 2025, the US Food and Drug Administration (FDA) reported that a serious defect was found in the heart support devices of Abiomed, part of Johnson & Johnson. The use of defective equipment can harm the health of patients or provoke death.
The problem affects the Automated Impella Controller (AIC). The AIC system is the primary control interface for Impella catheter pumps designed to provide patients with impaired heart function with circulatory support. Once implanted, the Impella pump actively pumps blood, increasing cardiac output and reducing stress on the heart. This ensures hemodynamic stability. Impella pumps can be used in situations such as complex coronary artery bypass or cardiogenic shock (the extreme degree of left ventricular insufficiency, characterized by a sharp decrease in myocardial contractility).
Johnson
Abiomed warned customers that due to the defect identified, the AIC controller may not detect the Impella heart pump when connected. The problem can lead to inadequate hemodynamic support, leaving patients with cardiogenic shock at increased risk. A pump detection error can occur with any of the Impella devices. The AIC screen does not display a visual alarm indicating that a problem has occurred.
As of June 13, 2025, Abiomed reported three deaths related to the problem described. Medical facilities are advised to ensure that a backup AIC is available to switch to in the event of a device failure.[2]
2024: Heart pump released that is easy to implant and take back
At the end of October 2024, Johnson & Johnson announced the successful completion of tests of the Impella ECP heart pump, which was developed by a subsidiary of Abiomed. The design of the new pump facilitates its installation and implantation compared to other models and should provide a serious competitive advantage.
The device consists of an introducer with a diameter of 9 on the French scale, or 3 mm, and a pump with a size of 21 on the French scale, which is compressed when introduced and removed. The small dimensions of Impella ECP not only facilitate implantation, but also allow the use of new methods of accessing heart chambers.
The company tested the device in a pivotal study involving 256 patients at 18 clinical centers. USA The patients were hemodynamically stable and planned to undergo a high-risk percutaneous coronary intervention to eliminate plaques and restore cardiac blood flow. 30 days after surgery, the rate of serious adverse cardiac and cerebrovascular events, including death and, stroke was 6.3%, far below the standard rate of 24.4%. Almost 6% of patients experienced severe bleeding associated with implantation of Impella ECP, serious vascular complications were observed in 1.6% of patients. None of the patients had aortic valve damage or serious hemolysis. At the same time, surgeon researchers noted the successful delivery of the pump through the aortic valve without using additional devices.
| | Despite our concerns, the average time taken for surgeons to get the device through the aortic valve was just over one minute, with a 100% successful implantation rate, the researchers noted.[3] | |
2023
Pump recall due to instruction errors
On August 17, 2023, the U.S. Food and Drug Administration (FDA) announced a new recall of heart pumps to Abiomed, part of Johnson & Johnson. Impella RP Flex with SmartAssist products fell under the program, the use of which can result in harm to the health of patients.
The named pump is intended for patients with acute right ventricular heart failure after implantation of an auxiliary device for the left ventricle, myocardial infarction, heart transplantation or open heart surgery. The article is implanted transdermally with a flexible cannula through the internal jugular vein. The system provides patient mobility, and therapy can be carried out up to 14 days.
The recall is because the Impella RP Flex with SmartAssist Heart Pump Operating Manual does not properly specify the precautions that health care providers should take into account when treating. We are talking primarily about patients who are prescribed anticoagulant therapy. Non-compliance with safety measures could lead to serious adverse health effects, including the risk of blood clots, the notice said. In the worst case, therapy can result in the death of the patient.
The recall includes Impella RP Flex with SmartAssist products with model number 1000323, which were delivered to the market between November 1, 2022 and August 2023. Abiomed has received 12 reports of harm to the health of people receiving therapy using these pumps. No deaths were recorded. The manufacturer said it will make changes to the operating instructions explaining the risk factors associated with the possibility of blood clots.[4]
Pump recall due to defect
On June 5, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of heart pumps to Abiomed, part of Johnson & Johnson. The use of these devices creates significant risks to the health and life of patients.
We are talking about Impella 5.5 with SmartAssist devices. This heart pump is designed to provide cardiac support for a long time while maintaining patient mobility. The solution optimizes patient recovery by using intelligent, real-time algorithms.
It is reported that in these cardiac devices, flushing fluid may leak from the side branch of the pump. If this happens, low pressure will be observed in the system. The result could be a full pump stop and discontinuation of therapy. In patients who are already in serious condition, a malfunction of the device can provoke a sharp deterioration in health and even death. Abiomed has registered at least 179 complaints about the operation of the system. Three patients experienced complications, but no deaths were reported.
The notice, published on the FDA website, states that copies of Impella 5.5 with SmartAssist with product code 0550-0008 are subject to recall. These heart pumps were delivered to the market from September 28, 2021 to March 6, 2023. In total, the defect affects 466 devices. The manufacturer urges against the use of problematic equipment and contact support to determine the return date. According to the FDA classification, the recall corresponds to category I (Class I), which indicates the maximum level of danger for patients.[5]
2022: Heart pump problems
On December 5, 2022, the Food and Drug Administration (FDA) announced that the agency was updating Abiomed's Impella RP system labeling to reflect the results of the final study.
Abiomed announced in October 2022 that the FDA had approved the Impella RP Flex system with the SmartAssist system delivered by the catheter. It is a system from Abiomed providing temporary support to the right ventricle of the heart for up to 14 days. After implantation of a left ventricular accessory device, myocardial infarction, heart transplant, or open heart surgery, people may develop acute right ventricular heart failure or decompensation.
In December 2022, the FDA updated the Impella RP system labeling: the system is indicated to provide temporary right ventricular support for up to 14 days in patients with a body surface area of ≥1,5 square meters. Who develop acute right ventricular heart failure or decompensation during. Less than 48 hours after implantation of a left ventricular accessory device, myocardial infarction, heart transplant, or open heart surgery, without the presence of deep shock, end organ failure, or acute neurological injury.
According to the FDA, patients in the post-approval study who met the criteria for enrollment in pre-market clinical trials showed similar survival rates. The agency reported that 23 of the 33 patients (69.7%) to be evaluated survived to 30 days after the device was explanted or discharged from the hospital or before the next longer therapy began.
However, among those who would not have undergone a pre-market study, survival was much lower than 18.6%, or 13 of the 70 patients assessed. Patients who would not have entered the study were more likely to be in a state of acute right-sided heart failure or decompensation for more than 48 hours. In addition, they may have experienced severe cardiogenic shock, end organ failure, or acute neurological injury.
As a result, the FDA updated and tightened the labeling indications. The authority said it would continue to work with Abiomed to monitor reports of adverse events and inform health care providers.[6]
Notes
- ↑ FDA reports another potential issue with J&J’s Abiomed Impella controllers
- ↑ Early Alert: Blood Pump Controller Issue from Abiomed
- ↑ J&J to seek FDA approval after small-bore Impella heart pump hits trial goal
- ↑ Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots
- ↑ Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
- ↑ FDA tightens indications for Abiomed Impella RP system
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