Boston Scientific Corporation

Boston Scientific's server software for LUX-Dx insertable cardiac monitors may delay notifications of atrial fibrillation (AF) burden alerts. This delay could postpone a doctor's evaluation or treatment of an irregular heart rhythm.

Boston Scientific's LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors may experience delays in sending AF Burden Alert notifications through their server software. These delayed alerts could postpone a patient's medical evaluation or treatment for irregular heart rhythms.

Boston Scientific's server software that supports LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors may delay notifications of abnormal heart rhythm (atrial fibrillation) alerts. This delay could postpone a patient's clinical evaluation or treatment of an irregular heartbeat.

The TheraSphere 360 Y-90 Management Platform has a software bug that can cause incorrect dose calculations. When a user modifies calculation inputs and recalculates, the new dose is computed correctly on screen, but vials previously added to the cart do not automatically update to match the revised calculation.

Boston Scientific identified that certain FARADRIVE Steerable Sheath devices may develop damage to the hemostatic valve if the dilator is not inserted correctly during preparation. Valve damage can allow air to enter the device, which may lead to air embolism—a serious condition where air bubbles reach the bloodstream and heart.

Boston Scientific identified that certain lots of the FARADRIVE Steerable Sheath (CLEAR) may have a hemostatic valve that can be damaged during device preparation if the dilator is not inserted correctly. Valve damage can allow air to enter, potentially causing an air embolism and patient harm.

Boston Scientific has identified that certain lots of the FARADRIVE steerable sheath may develop damage to the hemostatic valve during preparation if the dilator is not inserted correctly. This valve damage can allow air to enter the device, which may lead to air embolism (air in the bloodstream) and patient harm.

Boston Scientific identified that improper dilator insertion during device setup can damage the hemostatic valve in the FARADRIVE Steerable Sheath. Valve damage may allow air to enter the device, potentially causing air embolism and patient harm. The risk occurs in a subset of affected units when the dilator is not inserted straight through the center of the valve.

Boston Scientific identified specific FARASTAR Pulsed Field Ablation (PFA) generators with a configuration that cannot work safely with the FARAPOINT PFA catheter. Six units with specific serial numbers were distributed across Europe and need to be replaced.

Boston Scientific distributed 11 FARASTAR PFA Generator devices with Instructions For Use that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.

Boston Scientific distributed one FARASTAR Pulsed Field Ablation Generator with instructions that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.

Boston Scientific distributed 18 FARASTAR Ablation Generator units in Europe with incomplete Instructions For Use (IFU). The labeling did not include information about the FARAPOINT PFA catheter, which is used with the device. This discrepancy could affect proper device setup and use.

Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the device manifold. This could result in fluid leakage, inability to inject or aspirate properly, or complete separation of the syringe, potentially requiring device replacement and extending the procedure.

Boston Scientific has recalled certain CRE Wireguided catheters (18–20 mm, 240 cm) because the sterile pouches containing these devices may have been breached during manufacturing or packaging. A breach could allow bacteria or other contaminants to enter the device before use. No injuries have been reported to date.

Boston Scientific Corporation is recalling CRE Wireguided 15-18mm 240cm catheters due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide and may not maintain sterility if the pouch integrity is compromised. No injuries have been reported.

Boston Scientific has recalled certain CRE Wireguided 12-15mm catheters (model M00558480) due to a potential sterile breach in the device packaging pouches. The affected devices were distributed worldwide, including in the United States. No injuries have been reported.

Boston Scientific has recalled certain CRE Wireguided catheters (10-12mm, 240cm) due to a potential breach in the sterile packaging pouches. The affected devices were distributed worldwide. No injuries have been reported.

Potential sterile breach of the pouches in which devices are packaged.

Potential sterile breach of the pouches in which devices are packaged.

Boston Scientific Corporation is recalling certain CRE Pro Wireguided catheters (18–20 mm, 240 cm) due to a potential sterile breach in the packaging pouches. The breach could compromise the sterility of the devices before use. This affects approximately 81,543 units distributed worldwide.

Boston Scientific has recalled CRE Pro Wireguided catheters (15–18mm, 240cm) because some packaging pouches may have a sterile breach. This affects specific lot numbers distributed worldwide. No injuries have been reported.

Boston Scientific recalled certain CRE Pro Wireguided catheters (12–15 mm, 240 cm) due to a potential breach of the sterile packaging pouches. Affected units were distributed worldwide and have expiration dates between November 2028 and March 2029. The company has not reported any injuries related to this issue.

Boston Scientific Corporation is recalling CRE Pro Wireguided catheters (10–12 mm, 240 cm) because the sterile packaging pouches may have been compromised. This affects over 81,000 units distributed worldwide. The breach could allow contamination of the device before use.

Boston Scientific has recalled certain CRE Pro Wireguided catheters (8–10 mm, 240 cm) because the sterile pouches protecting these devices may have been breached during manufacturing or packaging. A breached sterile barrier could allow bacteria or other contamination to reach the device before use. The recall affects 81,543 units distributed worldwide.

Boston Scientific identified a potential sterile breach in the packaging of certain CRE Pro Wireguided 6-8mm 240cm catheters. The devices may have been exposed to contamination during packaging. No injuries have been reported.

Boston Scientific has recalled one INTERA 3000 Hepatic Artery Infusion Pump (model AP-0300H) due to the potential for leakage along the drug pathway from the pump through the catheter end. This is an implantable device used to deliver medication directly to the liver. The affected device was distributed in Ohio.

Boston Scientific is removing Orca Sterile Single Use Air/Water and Suction Valves from distribution because the suction button is sticking more often than expected. These valves are used during gastrointestinal endoscopic procedures to control air and water flow on endoscopes. No injuries have been reported.

Boston Scientific is recalling the Model SC-4318 Clik X Anchor (Lot #35107836) because sterile anchors may lack proper sterility assurance. Approximately 43 units were distributed across six U.S. states.

Boston Scientific has recalled certain reusable TCN Electrodes used in neuromodulation devices because they may not perform as expected. The affected electrodes come in multiple sizes and configurations, with about 49,251 units distributed worldwide.

Boston Scientific has recalled certain CSK Electrode models used in neuromodulation procedures because they may not perform reliably as intended. The affected electrodes come in multiple configurations and lengths. No injuries have been reported to date.