CLASS II Device recall · Reported 3 Oct 2018 · FDA Enforcement Report

Visionist X4 Crt-p (Cardiac Resynchronization Therapy Pacemaker) recalled

Boston Scientific is recalling Visionist X4 Crt-p (Cardiac Resynchronization Therapy Pacemaker), distributed in 48 states. The recall was initiated on 10 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVISIONIST X4 (CRT-P) model U228

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-3259-2018
FDA event ID: 81001
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 10 Sep 2018
FDA classified: 27 Sep 2018
Reported: 3 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

10 Sep 2018	Recall initiated by company
27 Sep 2018	Classified by FDA	+17 days
3 Oct 2018	Published in enforcement report	+6 days

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

Reason for recall

Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

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

VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Where it was distributed

AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY

Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

Which lots are affected?

VISIONIST X4 (CRT-P) model U228

Where was it sold?

AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

4 other products · FDA event 81001

This product is part of a recall event; the main page for the event is Valitude X4 Crt-p (Cardiac Resynchronization Therapy Pacemaker) recalled.

Reported	Class	Recall	Company	Reason	Where
3 Oct 2018	CLASS II	Valitude X4 Crt-p (Cardiac Resynchronization Therapy Pacemaker) recalled	Boston Scientific	Device Malfunction	48 states
3 Oct 2018	CLASS II	Proponent Pacemaker recalled by Boston Scientific	Boston Scientific	Device Malfunction	48 states
3 Oct 2018	CLASS II	Accolade Pacemaker recalled by Boston Scientific	Boston Scientific	Device Malfunction	48 states
3 Oct 2018	CLASS II	Essentio Pacemaker recalled by Boston Scientific	Boston Scientific	Device Malfunction	48 states

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