CLASS I ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

Cardiac Resynchronization Therapy (Crt)labeled as: Valitude Crt-p EL recalled

Boston Scientific is recalling Cardiac Resynchronization Therapy (Crt)labeled as: Valitude Crt-p EL. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesThe 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.

Quantity recalled685,776 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1771-2026
FDA event ID: 98615
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class I
Status: Ongoing
Recall initiated: 19 Mar 2026
FDA classified: 24 Apr 2026
Reported: 6 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

19 Mar 2026	Recall initiated by company
24 Apr 2026	Classified by FDA	+36 days
6 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98615

Reported	Class	Recall	Company	Reason	Where
6 May 2026	CLASS I	Pacemaker, Implantable Pulse Generator, Pacemaker recalled	Boston Scientific	Device Malfunction	MN

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