FDA Recall Database: Class I Recall: VALITUDE CRT-P, EL (Model Number U125) and EL… by Boston Scientific Corporation

Key facts

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Boston Scientific Corporation. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Boston Scientific Corporation should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Boston Scientific Corporation directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Boston Scientific Corporation’s FDA history

Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 272 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Is VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Num recalled?

Yes. FDA lists a Class I recall by Boston Scientific Corporation for VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128), reported 20250122, with status "Ongoing." FDA recall number: Z-0826-2025.

What is the recall class for Boston Scientific Corporation's recall?

FDA classified this recall as Class I. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death.

Why was VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Num recalled?

FDA's recall record states the reason as: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

Who should I contact about this recall?

Contact Boston Scientific Corporation directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Related enforcement actions

• Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 8-10mm 240cm →
• Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 15-18mm 240cm →
• Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 10-12mm 240cm →
• Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 6-8mm 240cm →
• Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 6-8mm 240cm →
• Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 18-20mm 240cm →
• Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 15-18mm 240cm →
• Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 12-15mm 240cm →