Boston Scientific Corporation recalls

Some TCD radiofrequency electrodes may have small cut marks on the Tyvek side of the sterile pouch. If the sterile barrier is compromised and the devices are used, microbial or other foreign material could enter patient tissue, which may lead to infection, pain, inflammation, allergic reaction, or the need for more medical or surgical treatment. No injuries have been reported.

Moderate·FDA·Nov 6, 2026

Boston Scientific is recalling certain Nalu TD2 Therapy Discs and TD2 Patient Kits used with the Nalu Neurostimulation System. A firmware problem can cause the disc to try to restart and then fail, so it stops working. If no backup disc is available, the implanted pulse generator may also stop working, which could leave pain signals unblocked. No injuries have been reported.

Moderate·FDA·Oct 29, 2026

Boston Scientific is recalling 41 Direxion Torqueable Microcatheter models. The hydrophilic coating on the outer tip may not have been fully cured, and some nitinol sleeves have raised ridges caused by laser-cutting misalignment. No injuries have been reported.

Moderate·FDA·Oct 22, 202641 products

Boston Scientific discovered that 403 units of the NaviFlex LW Pusher Advx Panc. Stent were incorrectly manufactured with an extra guidewire exit port that should not be present on this device model. This manufacturing error could affect how the device performs during use.

Moderate·FDA·Oct 21, 2026

The tip of certain Boston Scientific Imager II Angiographic Catheters may fracture or detach during use. Fragments could remain in the patient's body or travel through blood vessels, potentially causing a prolonged procedure or life-threatening blood clot.

Serious·FDA·Sep 30, 2026

Certain power adapters used with the StoneSmart Connect Console may have higher-than-expected electrical resistance in the grounding path. These adapters may fail electrical safety testing during installation, which could affect device safety.

Moderate·FDA·Sep 23, 2026

Boston Scientific is recalling server software that supports its LUX-Dx, LUX-Dx II, and LUX-Dx II+ insertable cardiac monitors. The recall covers three products, one for each region: US, EU, and ANZ. The software can delay notifications of AF Burden Alerts, which are alerts about atrial fibrillation, and a delayed alert may delay clinical review or treatment. No injuries have been reported.

Moderate·FDA·Sep 9, 20263 products

Boston Scientific is recalling two ENROUTE Transcarotid Neuroprotection System products: the standard system (Material Number SR-200-NPS) and the Plus system (SR-250-NPS). The recall covers about 164,700 units, distributed in the US and to Australia, Canada, China and Jamaica. The arterial sheath tip may separate, fully or partially, during use. No injuries have been reported.

Serious·FDA·Aug 26, 20262 products

Boston Scientific is recalling two Suture Cinch endoscopic tissue approximation devices, the OverStitch Suture Cinch and the Suture Cinch Long. The devices may fail to deploy the cinch implant or fail to cut the suture as intended. The recall covers 60,654 units of each product, distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

Boston Scientific is recalling certain Radial Jaw 4 Jumbo Biopsy Forceps (240cm) because the packaging may not keep the device sterile. The affected lot is 38496094, sold in US nationwide distribution, with international distribution still pending. No injuries have been reported.

Moderate·FDA·Aug 12, 2026

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.

Moderate·FDA·Jul 29, 2026

Boston Scientific found that some air leak complaints were linked to damage to the sheath's hemostatic valve. The damage can happen when the dilator is inserted at the wrong angle during setup, and it may allow air into the device, creating a potential air embolism. This recall covers four FARADRIVE steerable sheath versions, with about 776,000 units affected. No injuries have been reported.

Moderate·FDA·Jul 29, 20264 products

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.

Moderate·FDA·Jul 29, 2026

Boston Scientific is recalling three FARASTAR pulsed field ablation generator products because the instructions for use shipped with them did not include information about the FARAPOINT PFA catheter. A total of 30 units were affected, distributed in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. No injuries have been reported.

Moderate·FDA·Jul 29, 20263 products

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.

Moderate·FDA·Jul 22, 2026

Boston Scientific is recalling 12 sizes of its CRE and CRE Pro Wireguided balloon catheters because the pouches they are packaged in may not keep the devices sterile. The recall covers 81,543 units per product and was distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Jul 8, 202612 products

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.

Moderate·FDA·Jul 1, 2026

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.

Moderate·FDA·Jun 17, 2026

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.

Moderate·FDA·Jun 17, 2026

Boston Scientific is recalling two lines of reusable electrodes, CSK and TCN, because they may not meet expected performance levels. The recall covers 2 products with about 81,000 units total, distributed across the US and several other countries. No injuries have been reported.

Moderate·FDA·Jun 17, 20262 products

Boston Scientific is recalling certain EndoVive Safety PEG Kits that contain ChloraPrep Triple Swabsticks with open or damaged packaging. The affected swabsticks may have lost sterility or dried out. The rest of the kit components remain safe and unaffected.

Moderate·FDA·Mar 18, 2026

Boston Scientific is recalling six versions of its AXIOS Stent and Electrocautery-Enhanced Delivery System after reports that the stent did not deploy or expand properly. The most likely result is a longer procedure while the device is swapped for a new one. In rare cases, the stent may need to be removed through a second endoscopic or surgical procedure. No injuries have been reported.

Serious·FDA·Feb 11, 20266 products

Boston Scientific found that certain batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters may not inflate or deflate properly during use due to a manufacturing process variation. The issue affects only catheters made between September 12 and October 13, 2025. The company has corrected the manufacturing process.

Moderate·FDA·Jan 21, 2026