Medtronic, Sued

Medtronic Sued Over Insulin Pump Retaining Rings as Canadian Launch and Trial Data Stack Up

Published on 11/03/2026 at 14:30 | Editorial boerse-global.de
Four patients sue Medtronic in California over insulin pump retaining rings; stock rises as registry data back Sphere-9 and PulseSelect.
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Four patients have taken Medtronic companies to court in California, alleging that faulty retaining rings on insulin pumps could trigger incorrect insulin delivery and that consumers were never adequately warned. The suit, filed Friday according to media reports, lands in the middle of one of the medical-device maker's busiest stretches of the year.

Investors shrugged off the litigation. The stock added 2.6% on the previous day to close at 88.68 €, though it slipped 0.6% to 88.16 € in the latest session.

Registry Data Back the Ablation Franchise

Two days after the lawsuit surfaced, Medtronic was touting real-world evidence. On October 22 it reported positive registry results for the Sphere-9 catheter and the PulseSelect PFA system, presented at the APHRS congress. The analyses examined procedural safety and outcomes in patients with atrial fibrillation and ventricular tachycardia.

The APEX registry covered 1,050 patients, with a major-complication rate of 1.1%. In REAL PULSE, spanning 1,160 patients, Medtronic reported an acute procedural success rate of 100% and a major-complication rate of just 0.09%. Both registries draw on routine clinical practice, and the company described the findings as positive.

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TYRX III Reaches Canada

Medtronic's absorbable antibacterial envelope TYRX III launched in Canada, with the first commercial procedures already under way, the company said. The product is aimed at patients receiving implantable cardiac devices or neuromodulation equipment.

Five Pacemakers Win CE Mark

Europe cleared the way for the Vitalis portfolio on October 19. The CE mark, announced that day, covers five pacemakers, including models built for conduction system pacing, and permits sales across the continent.

Evolut Trial Design Debuts at TCT

The company used TCT 2026 on Saturday to unveil the design and baseline characteristics of its Evolut EXPAND TAVR II study. The trial focuses on transcatheter aortic valve replacement in patients with moderate aortic stenosis, testing the procedure alongside guideline-directed medical therapy.

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FDA Tags SmartSync Recall as Class II

Regulators moved on CareLink SmartSync on October 27, when the FDA classified the recall as Class II. A software flaw could cause the system to display inaccurate remaining-battery estimates for certain pacemakers. The FDA notice identifies the affected models specifically. Medtronic had initiated the recall on September 24, meaning the agency's classification followed the company's own action.

Marinaro Adds Greater China to His Brief

On the leadership front, Michael Marinaro picked up additional duties. A mandatory disclosure dated October 15 showed the board approved his appointment as President effective October 14. Marinaro kept his existing responsibilities and took on oversight of Greater China activities, pairing his current remit with the regional role.

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