—#196397

Product

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

FDA product code: NVY — Permanent Defibrillator Electrodes
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P110042
Affected lot / code info: UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-09-30
Posted by FDA: 2022-10-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.