Key facts
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Model Number U228, VISIONIST CRT-P EL MRI |
| Classification | Class I |
| Recall number | Z-0105-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). |
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 Model Number U228, VISIONIST CRT-P EL MRI 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
- What is the FDA recall number for this event?
- FDA recall number Z-0105-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
- Is Model Number U228, VISIONIST CRT-P EL MRI recalled?
- Yes. FDA lists a Class I recall by Boston Scientific Corporation for Model Number U228, VISIONIST CRT-P EL MRI, reported 20251022, with status "Ongoing." FDA recall number: Z-0105-2026.
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Related enforcement actions
Full FDA history for Boston Scientific Corporation- 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 →
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). FDA Class I Recall: Model Number U228, VISIONIST CRT-P EL MRI by Boston Scientific Corporation — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/boston-scientific-corporation-z-0105-2026-2025-10-22
"FDA Class I Recall: Model Number U228, VISIONIST CRT-P EL MRI by Boston Scientific Corporation — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/recall/boston-scientific-corporation-z-0105-2026-2025-10-22.
Argus HQ Research. "FDA Class I Recall: Model Number U228, VISIONIST CRT-P EL MRI by Boston Scientific Corporation — Recall Details." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/boston-scientific-corporation-z-0105-2026-2025-10-22.
@misc{argushq_argushq_ai_recall_boston_scientific_corporation_z_0105_2026_2025_10_22_2025,
title = {FDA Class I Recall: Model Number U228, VISIONIST CRT-P EL MRI by Boston Scientific Corporation — Recall Details},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/boston-scientific-corporation-z-0105-2026-2025-10-22},
note = {Accessed: July 24, 2026}
}Source: FDA.gov — Recalls ↗