Boston Scientific has initiated multiple product recalls covering cardiac ablation generators and vascular access sheaths due to labeling discrepancies and air embolism risks. The recalls affect a broad mix of devices used in cardiac and vascular procedures across several international markets, with the FARADRIVE sheath recalls involving more than 700,000 units across US, global, and IDE use. The PFA generator issues mainly involve labeling and smaller unit counts, while the Rapid Refill system recall brings in a third-party component issue. Regulators and hospitals are assessing the implications for device safety protocols, clinical workflows, and future use of the impacted products.
Boston Scientific CorpMultiple product recalls due to labeling and air embolism risks, affecting device safety and regulatory compliance.
