Abiomed has issued an urgent medical device correction for its Impella RP and Impella RP Flex series of heart pumps.

In a letter sent to customers on January 27, Abiomed said the voluntary device correction involves the differential pressure sensor of its Impella RP and Impella RP Flex devices with SmartAssist, which have the potential to malfunction and cause the sensor values to drift.

When this occurs, the automated controller display may show inaccurate information about the device’s pump flow rates, pulmonary artery placement signal and pulsatility index, and central venous placement signal, the letter stated. 

Abiomed noted that users of Impella RP devices may potentially act on the inaccurate information displayed on the automated controller, such as making inaccurate P-level adjustments or pump exchanges. The company said that the differential pressure sensor is present only on Impella RP devices, and the issue does not affect hemodynamic support.

Overall, an Abiomed review found that differential pressure sensor drift occurred in 2.5% of Impella RP cases between September 2023 and January 2026. Of these, 0.5% of cases involved pump or console exchanges. There have been 22 serious injuries, but no deaths have been linked to differential pressure sensor drift, Abiomed said. 

The FDA has also released an early alert for this device series, and it is reviewing information about the issue.

In its letter, Abiomed said there is no need to remove the device. However, the company instructed clinicians to “monitor patient hemodynamics with approved diagnostic devices and continue to verify Impella positioning with imaging before clinical interventions.” 

Clinicians should also use the Instructions for Use when referencing P-level flow rates, rather than the automated controller display. They should also use trend pump metrics when assessing changes. Any sudden changes in the displayed flow rate should be measured using temporal trends as well as the flow rate in the Instructions for Use.

“Patient safety is our top priority and all impacted customers have been notified. Importantly, this is not a product removal and the differential pressure sensor drift does not impact the pump’s ability to provide hemodynamic support. Hospitals can continue using Impella RP heart pumps and updates will be made to the Instructions for Use,” Erin Farley, senior manager of public relations at Johnson & Johnson MedTech, Abiomed’s parent company, wrote in an email to Medscape Medical News.

The Impella RP series has been the subject of several other voluntary device corrections, including class I recalls in December 2024 and June 2023.

Clinical Impact

While the risk for this issue is clinically significant, it is more indirect than an immediate pump failure, Cesar Guerrero, MD, medical director of Mechanical Circulatory Support at Baylor University Medical Center, told Medscape Medical News.

“The main clinical concern is that management decisions — such as P-level adjustments, repositioning, or device replacement — may be affected by these imprecise readings,” said Guerrero, who is a clinical associate professor of medicine at Texas A&M University Health Science Center College of Medicine. “Nevertheless, in managing patients with right ventricular shock, clinicians seldom depend on a single console value for major decisions. Instead, therapy is guided by an overall assessment of clinical data, including invasive hemodynamics (Swan-Ganz catheter), imaging (echocardiography), and perfusion markers such as lactate, laboratory results, and urine output.” 

Clinical outcomes with Impella RP devices can vary depending on when the devices are used, Guerrero explained.

“Outcomes tend to be worse when the device is applied very late, after a patient has been in shock for several days or has already developed severe organ damage or brain injury — situations in which recovery of the right side of the heart is unlikely, regardless of the support method,” he said.

Patients with isolated right-heart failure tend to do better when the device is placed quickly and do not require more complex external support systems, he added.

Postapproval study data of Impella RP devices also point to the need for early treatment in patients with isolated right ventricular failure, Guerrero noted.

“[T]his situation underscores the necessity of integrating device readouts with invasive hemodynamic monitoring and echocardiography in the management of complex shock,” he said.

Guerrero reported no relevant financial relationships.

Jeff Craven is an independent journalist living in Wilmington, Delaware.