Has Boston Scientific Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation, including 272 recalls and 0 warning letters.

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.

FDA Recall Database: Class I Recall: Model Number S701 ALTRUA 2 SR SL Pacemaker by Boston Scientific Corporation

Here's the summary: FDA classified a recall by Boston Scientific Corporation as Class I, reported 20251022. The affected product is Model Number S701 ALTRUA 2 SR SL Pacemaker (recall number Z-0098-2026). 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).. Status: Ongoing.

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 S701 ALTRUA 2 SR SL Pacemaker
Classification	Class I
Recall number	Z-0098-2026
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 S701 ALTRUA 2 SR SL Pacemaker 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

Has Boston Scientific Corporation had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation, including 272 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-0098-2026.
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.

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Full FDA history for Boston Scientific Corporation

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.

APA

Argus HQ Research (2025). FDA Recall Database: Class I Recall: Model Number S701 ALTRUA 2 SR SL Pacemaker by Boston Scientific Corporation. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/boston-scientific-corporation-z-0098-2026-2025-10-22

MLA

"FDA Recall Database: Class I Recall: Model Number S701 ALTRUA 2 SR SL Pacemaker by Boston Scientific Corporation." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/recall/boston-scientific-corporation-z-0098-2026-2025-10-22.

Chicago

Argus HQ Research. "FDA Recall Database: Class I Recall: Model Number S701 ALTRUA 2 SR SL Pacemaker by Boston Scientific Corporation." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/boston-scientific-corporation-z-0098-2026-2025-10-22.

BibTeX

@misc{argushq_argushq_ai_recall_boston_scientific_corporation_z_0098_2026_2025_10_22_2025,
  title = {FDA Recall Database: Class I Recall: Model Number S701 ALTRUA 2 SR SL Pacemaker by Boston Scientific Corporation},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/boston-scientific-corporation-z-0098-2026-2025-10-22},
  note = {Accessed: July 24, 2026}
}

Source: FDA.gov — Recalls ↗