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EMBLEM S-ICD, Subcutaneous Implantable Defibrillators… recallZ-0151-2023 · Boston Scientific Corporation · initiated Sep 30, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0151-2023
Status
Open, Classified
Initiated by the company
Sep 30, 2022
Posted by the FDA
Oct 31, 2022
Recalling firm
Boston Scientific Corporation
Quantity
7 devices
Product code
NVY
FDA submissions
P110042
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 description

EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

Code information (models, lots, serial numbers)

UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.

Other devices under the same FDA submission

10 devices cleared under P110042 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 90985).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page