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MedTech Current publications and recall entries tagged Boston Scientific.
FDA classified Boston Scientific's Imager II Angiographic Catheter recall as Class I after reduced stabilizing agents in catheter tips were linked to tip degradation and possible detachment during use.
This event separates device sensing from downstream alert delivery: the implant may function as intended while server-side software delays the notification clinicians rely on. That makes the recall a useful example of how remote-monitoring infrastructure can create clinically meaningful risk without requiring replacement of the implanted device itself.
FDA has classified the recall of Boston Scientific Infinion CX Leads as Class I. The manufacturer is removing unused leads due to mechanical stress at anchor sites that may cause lead fractures and inadequate stimulation.
FDA has classified the recall of Boston Scientific ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus as Class I due to reports of arterial sheath tip separation during clinical use.