Boston Scientific recalled all unused Infinion CX leads used in its spinal cord stimulator systems (SCS) after identifying an issue that could result in “high impedance measurements or lead fractures,” the company said. The company said the lead body could experience mechanical stress at the anchor site, which could cause the abnormal impedance measurements or […]
Recalls
Boston Scientific recalls, discontinues angiographic catheter sales
Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured with reduced levels of stabilizing agents in the tips,” according […]
Medtronic recalls reflux testing system after 184 serious injuries
Medtronic initiated a global voluntary recall for certain lots of its Bravo calibration-free (CF) reflux testing system after reports of 184 serious injuries associated with a deployment control problem. Medtronic recalled the device “due to a risk of attachment and detachment issues related to the system’s delivery system,” a Medtronic spokesperson told MassDevice. “To ensure […]
Johnson & Johnson’s Abiomed recalls Automated Impella Controllers after 3 patient deaths
Johnson & Johnson’s Abiomed recommends customers remove all Automated Impella Controllers (AICs) from where they’re used or sold after 37 reports of serious injuries and three deaths were linked to component failures. Abiomed identified purge cassette recognition issues “resulting from failures of the purge flag component within the purge pressure sensor assembly.” J&J issued the […]
FDA issues Class I recall for Hamilton Medical ventilator components
The FDA issued a Class 1 recall for certain Hamilton Medical coaxial breathing circuit sets after reports of four serious injuries. Hamilton Medical said certain lots of coaxial breathing circuit sets used with its Hamilton-C1, Hamilton T-1 and Hamilton-MR-1 ventilators are preassembled with an expiratory valve set that doesn’t perform as intended. “In some cases, […]
BD recalls vascular access system needles after 4 patient deaths
Becton, Dickinson and Company (BD) issued a nationwide recall for specific lots of BD Intraosseous Vascular Access System Needle Sets after reports of four patient deaths. The FDA classified the recall as a Class I recall on August 17. A Class I recall is the agency’s most serious type of recall, in which use of […]
FDA warns on percutaneous catheter issue from Boston Scientific
The FDA today issued an early notice after Boston Scientific (NYSE:BSX) recommended the removal of certain percutaneous catheter systems. In a letter dated July 9, 2026, Boston Scientific told customers to identify affected EnRoute transcarotid neuroprotection system (NPS) and EnRoute NPS Plus products and cease use and distribution. Customers should return affected products to the […]
FDA issues early alert for certain Resmed Astral ventilators
The FDA issued an early alert warning customers of potential issues with certain Resmed (NYSE:RMD) ventilator systems. In its communication, the FDA said Resmed issued a letter to affected customers recommending the correction of certain Astral 100 and Astral 150 ventilators as soon as replacement parts become available. Patients should not stop using the ventilator […]
Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Medtronic (NYSE:MDT) has issued a letter to affected customers recommending the removal of certain lots of its Harmony delivery catheter system (DCS). In a notice published by the FDA, the agency said Medtronic’s recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as […]
Terumo initiates voluntary thoracic stent graft recall after 3 deaths
Terumo announced today that it initiated a voluntary recall of specific models of its Relay Pro thoracic stent graft system. Affected products include the Relay Pro NBS (non-bare stent) models with diameters ranging from 32 mm to 46 mm. The recall spans approximately 7,000 affected units sold between May 2024 and March 2026. Tokyo-based Terumo […]
Zoll faces FDA warning letter related to quality, reporting processes
The FDA has issued Zoll Medical a warning letter outlining quality system regulation violations and violations of medical device reporting (MDR). An inspection of the Chelmsford, Massachusetts-based company from Feb. 27, 2025, through April 15, 2025, identified the violations, according to the FDA letter issued on April 30, 2026. Zoll develops a range of products, including […]
