Two Separate Class II Recalls Cover Direxion Catheters and Nalu Devices
Key Facts
The U.S. Food and Drug Administration recorded a Class II recall for Direxion catheters, initiated by Boston Scientific on September 16, 2026, and published by the agency on October 22; it remained open and classified when reviewed. The action concerns specific manufacturing defects in the catheter, and the company asked users to immediately stop using or distributing affected products and quarantine them. The safety notice said the most serious potential harm was life-threatening embolism, but that it was "unlikely." The company added that it had received no complaints of this harm as of the date of the notice. The recall highlights risks distinct from the software malfunction affecting another company device, as this action concerns the safety of the catheter coating and sleeves during preparation or use.
The FDA record identified the defect as insufficient ultraviolet curing of the hydrophilic coating on the distal portion of the catheter, along with raised burrs on the nitinol sleeves caused by laser-cut misalignment. The company notice reported increased catheter resistance during preparation or use, a problem that could be associated with the potential harm. The rate of complaints related to increased resistance and resulting damage was 0.352% as of September 16, 2026, according to the notice. The company recorded one serious injury, involving separation of the catheter shaft inside the body. The event required an additional intervention to retrieve the portion left inside the body, and was the only serious injury recorded in the notice.
The safety notice limited the Direxion recall to specified lots, saying the company's other products were not affected. Boston Scientific asked users to immediately stop using or distributing any remaining product from the affected lots, quarantine it and return it. It also recommended continuing to monitor patients according to usual practice. The action covers specified Direxion catheters and does not include Nalu TD2 products, which are subject to a separate recall. The distinction means the two defects are not a single event: the first is related to catheter components and manufacturing quality, while the second involves software in a neurostimulation device.
The Nalu recall covers the Nalu TD2 therapy disc with firmware, reference number 34014-001, and the TD2 patient kit, reference number 74011, within the Nalu neurostimulation system. The company initiated the action on September 30, 2026, and the FDA published it on October 29; the record classified it as Class II and it remained open and classified when reviewed. The record identified firmware versions v2.0.71 and v2.0.77 as affected. The disc may attempt to reboot and then fail, causing it to lose function. If a replacement TD disc is unavailable, the implanted pulse generator may become nonfunctional.
The company told health care professionals that patients receive two TD discs when therapy is activated, and that therapy can be restored using a replacement disc. Its notice said, "Patients receive two TD discs when therapy is activated, so therapy can be restored using a replacement disc." The company asked providers to identify affected patients and arrange a firmware update. Replacement discs provide a way to restore therapy if one of the two discs fails, according to the notice. The action requires coordination between providers and patients to identify affected devices and update the software.
The recalls come as Boston Scientific reported third-quarter 2026 results, with net sales of $5.138 billion, up 1.5% from the same period a year earlier. Performance varied by region; sales in Europe, the Middle East and Africa grew 4.4% on a reported basis and 6.1% operationally. In Asia-Pacific, sales fell 0.6% on a reported basis and 1.1% operationally. Net income attributable to the company's shareholders was $582 million, or $0.40 per share, compared with $755 million and $0.51 per share a year earlier. Adjusted earnings per share were $0.73, versus $0.75 in the third quarter of 2025.
The company forecast 2026 net sales growth of about 4.25% on a reported basis and 3.75% organically. By contrast, it expected fourth-quarter sales to decline between 3.0% and 1.0% from the same period a year earlier. The forecasts provide context for the company's performance in the remaining months of the year as it carries out product safety actions. BSX shares closed at $44.70 on November 10, 2026. The Direxion recall remained classified and open with the FDA, according to the record, and the Nalu recall also remained open and classified when reviewed.