Z-0365-2018Class II

VISIONIST CRT-P Pacemaker

Name: Z-0365-2018 VISIONIST CRT-P Pacemaker
Creator: Boston Scientific Corporation
Published: 2017-12-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-12-07 / Open, Classified / root cause: design

FDA source

Boston Scientific Corporation began a recall of VISIONIST CRT-P Pacemaker on 2017-12-07. FDA classified it as Class II and gives the reason as "Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0365-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-12-07
Posted: 2018-01-15
Recalling firm: Boston Scientific Corporation
Product: VISIONIST CRT-P Pacemaker
Product code: NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Reason for recall: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Root cause tag: design
FDA root cause: Device Design
Action: On December 19, 2017 the firm sent a letter to all their medical consignees stating the following: December 2017 Dear Doctor, Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude (Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV). Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems. Root Cause Investigation The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A. Engineering analysis and
Distribution: AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide
Product codes and lots: Model U225 and Model 226

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0365-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0354-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0355-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0356-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0357-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0358-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0359-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0360-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0361-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0362-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0363-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0364-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0365-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0366-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0367-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0368-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0369-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0370-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0371-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0372-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0373-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0374-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0375-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0376-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15
Z-0377-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-01-24	2018-01-15

Product code NKE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)