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 … [Read more...] about Boston Scientific discontinues Imager II angiographic catheter sales
Recalls
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 … [Read more...] about FDA issues Class I recall for Hamilton Medical ventilator components
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 … [Read more...] about FDA warns on percutaneous catheter issue from Boston Scientific
Baxter warns on intravascular administration sets
The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the … [Read more...] about Baxter warns on intravascular administration sets
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 it could … [Read more...] about Medtronic warns on Harmony transcatheter pulmonary valve delivery system
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 … [Read more...] about Terumo initiates voluntary thoracic stent graft recall after 3 deaths
InspireMD recalls CGuard Prime 135 cm stent delivery system in US, gets nod to study neuroprotection tech
InspireMD (Nasdaq:NSPR) announced today that, in consultation with the FDA, it recalled its CGuard Prime 135 cm carotid stent delivery system. The company said it initiated a voluntary recall for the system. After a controlled launch, the company determined that the technical success of the delivery system during carotid artery stenting … [Read more...] about InspireMD recalls CGuard Prime 135 cm stent delivery system in US, gets nod to study neuroprotection tech
Boston Scientific has a potentially serious Axios stent recall
The FDA has flagged a Boston Scientific recall of its Axios stent and delivery system as potentially serious. The recall involves problems with stent deployment and expansion, according to the notice that the FDA published on Jan. 16. Regulatory reports in countries including the U.K. and Malaysia say the issues were associated with … [Read more...] about Boston Scientific has a potentially serious Axios stent recall
Vantive updates instructions after dialysis system tubing issue
The FDA issued a notice related to updated instructions for the Vantive Prismaflex control units after reports of a potential tubing issue. Vantive, the former kidney care unit of Baxter, issued a letter on Jan. 6 informing customers of the updated instructions. The FDA said it became aware of the "potentially high-risk device issue" related to … [Read more...] about Vantive updates instructions after dialysis system tubing issue
Olympus issues voluntary recall for certain endoscope needles
Olympus announced a voluntary, global medical device removal of certain ViziShot 2 FLEX (19G) EBUS -TBNA (ViziShot 2 FLEX) needles. The company manufactured affected needles prior to May 12, 2025. It initiated the recall after receiving reports of device components detaching during procedures. Olympus said that it assessed the issue after … [Read more...] about Olympus issues voluntary recall for certain endoscope needles
