# FDA recall Z-1771-2026

> **Boston Scientific Corporation** · Class I · device recall initiated 2026-03-19.

## 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 for recall

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

## Distribution

worldwide

## Key facts

- **Recall number:** Z-1771-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-19
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1771-2026

## Citation

> AI Analytics. FDA recall Z-1771-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1771-2026. Source: US FDA. Licensed CC0.

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