---
title: "Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALIT... — FDA record Z-1771-2026 | Is It on Recall"
description: "Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE\" family of pacemakers and cardiac resynchronization therapy pac"
url: https://isitonrecall.com/recall/fda-device-z-1771-2026-boston-scientific-cardiac-resynchronization-therapy-crt-labeled-as-1-valitude-crt-p-el-model-number/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALI... — FDA record Z-1771-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.
- **Reason**: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia
- **Classification**: Class I
- **Recalling firm**: Boston Scientific Corporation
- **Quantity**: 685,776 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1771-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1771-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | The advisory population includes all models listed; however, the bounding differs by battery type: " All serialized DR-EL pacemakers and CRT-Ps from the ACCOLADE family are included in the advisory population. " ACCOLADE DR-SL and SR-SLs with a use-by-date (UBD) on or before 30 June 2025 are included in the advisory population. Model number alone will not precisely identify individual DR-SL or SR-SL devices in the advisory population. To determine if a device is affected, enter a model/serial into the device lookup tool at www.BostonScientific.com/lookup. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: May 6, 2026
- **Recall initiation date**: Mar 19, 2026
- **Center classification date**: Apr 24, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1771-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Boston Scientific Corporation records](https://isitonrecall.com/brand/boston-scientific-corporation/)