Four cardiac device safety actions landed on the FDA’s recall and early alert list in May, including a third Class I correction tied to Boston Scientific’s ongoing pacemaker battery issue and two separate Abiomed Impella alerts. On the innovation side, a startup won a first-of-its-kind clearance for AI software that estimates a key heart failure pressure marker without an invasive procedure.
Here are five heart device recalls and approvals to know:
1. Boston Scientific pacemakers hit with another Class I recall
Boston Scientific initiated a correction for its Accolade family of pacemakers and CRT-Ps after identifying a subpopulation with increased potential to initiate Safety Mode during telemetry due to high battery impedance. As of March 18, the company reported four deaths and 2,557 serious injuries. The action follows previous recalls in December 2024 and August 2025, according to a May 7 FDA notice. Physicians are directed to upgrade affected devices to Brady SMR6 software during an in-person visit.
2. Bolton Medical issues Class I recall for thoracic stent graft linked to 3 deaths
Bolton Medical issued an Urgent Medical Device Recall providing updated use instructions for all Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above, and recommends customers consider alternative stent-graft options until mitigation measures are in place. Difficulties releasing the stent graft may result in stent graft displacement or an inability to release it, potentially requiring conversion to open surgical repair. As of April 23, Bolton Medical reported three deaths associated with the issue, including one aortic perforation and two open-surgery conversions resulting in death due to stroke, according to a May 20 FDA notice.
3. Abiomed Impella CP heart pump flagged for design specification failure
Abiomed issued a letter recommending certain Impella CP Sets with SmartAssist be removed from where they are used or sold after the company identified that specific distributed units do not meet design specifications. As of May 7, Abiomed reported three pump exchanges, with the potential for serious injuries and one death associated with the issue, according to a May 27 FDA early alert.
4. Abiomed Automated Impella Controller flagged for software-triggered restart
Abiomed issued an Urgent Medical Device Recall recommending updated use instructions for all Automated Impella Controllers after identifying that a software error may cause the AIC to restart when used with left ventricular Impella devices. The restart occurs when a patient experiences an extended period of no residual pulsatility followed by a sudden change in left ventricular pressure, causing the AIC screen to go black and the pump to stop for approximately 35 seconds — leaving the patient unsupported, according to a May 21 FDA early alert.
5. Cardiosense wins first-of-its-kind FDA clearance for noninvasive heart failure pressure software
The FDA granted De Novo classification to Cardiosense’s PCWP Analysis Software, a first-in-class AI-enabled tool that estimates pulmonary capillary wedge pressure — a key indicator of fluid buildup that can signal worsening heart failure before symptoms appear — without the need for an invasive procedure. The software is indicated for adult patients with heart failure with reduced ejection fraction, an LVEF of 40% or less, and NYHA Class II, III or IV symptoms, according to a May 27 company news release.
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