Z-0152-2023Class II

EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile

Name: Z-0152-2023 EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile
Creator: Boston Scientific Corporation
Published: 2022-09-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-09-30 / Open, Classified / root cause: software

FDA source

Boston Scientific Corporation began a recall of EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile on 2022-09-30. FDA classified it as Class II and gives the reason as "There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0152-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-30
Posted: 2022-10-31
Recalling firm: Boston Scientific Corporation
Product: EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Product code: NVY Permanent Defibrillator Electrodes
Reason for recall: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: The recalling firm emailed Dear Health Care Professional or Hospital Administrator retrieval letters dated 9/30/2022 to their sales representatives on 9/30/2022 who began hand delivering them immediately in the U.S. for delivery to those consignees who were believed to have unimplanted devices in their possession. The letter described the issue and said their Boston Scientific sales representative is available to support this retrieval and listed the following steps to be taken: (1) Immediately segregate all affected product listed in Appendix A of the letter to ensure it will not be used; (2) Complete the attached Reply Verification Tracking Form and return it via the email address provided or via FAX; and (3) Ship product back to Boston Scientific, and the address was provided. OUS notification began 10/3/2022. For the U.S. patients who have already been implanted with the device, correction letters are to be hand-delivered to the doctors the week of 10/17/2022 and the sales representatives will send confirmation of delivery back to the recalling firm. No reply form was enclosed with the correction letter. These letters will be personalized/customized with the name of the following or implanting physicians or clinics. The letters will be dated October 2022 and contain the patient's name, date of birth, and the model/serial number and GTIN implanted. The letter will describe the issue, clinical impact, and recommendations regarding follow-up interval, patient notes entry, and medial records. Prophylactic replacement is not recommended as the issue does not affect the S-ICDs performance or the actual battery longevity.
Quantity in commerce: 142 devices
Distribution: Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.
Product codes and lots: UPN: 00802526584404, Serial numbers: 169280, 169298, 169494, 169753, 169776, 169934, 169941, 170003, 169547, 169151, 169315, 169514, 169851, 169879, 169292, 169696, 169786, 169788, 169852, 170002, 169400, 169405, 169898, 169973, 169885, 169335, 169233, 169608, 169304, 169410, 166452, 169278, 169319, 169321, 169651, 169688, 169864, 169920, 169235, 169277, 169834, 169472, 169417, 169202, 169329, 169426, 169511, 169529, 169630, 169757, 169963, 167092, 169236, 169301, 169310, 169316, 169393, 169436, 169485, 169537, 169543, 169565, 169567, 169571, 169579, 169582, 169599, 169601, 169606, 169663, 169771, 169238, 169323, 169680, 169270, 169265, 169372. UPN: 00802526581519, Serial numbers 169312, 169409, 169421, 169428, 169521, 169561, 169493, 169654, 169653, 169635, 169731, 169477, 169495, 169496, 169474, 169491, 169468, 169455, 169442, 169446, 169435, 169447, 168979, 169271, 169384, 169353, 169371, 169351, 169203, 169469, 169471, 169314, 169342, 169475, 169448, 169404, 169407, 169450, 169396, 169470, 169356, 169373, 169402, 169413, 169441, 169539, 169545, 169551, 169674, 169267, 169350, 169589, 169307, 169595, 169596, 169600, 169286, 169603, 169605, 169206, 169340, 169502, 169505, 169510, 169348.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0152-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0151-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31
Z-0152-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31

Product code NVY

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)