Recall Z-0151-2023 ยท NVY Permanent Defibrillator Electrodes
Boston Scientific Corporation
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
| Date | Oct 31, 2022 (initiated Sep 30, 2022) |
| Status | Open, Classified |
| Reason | There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. |
| 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; |
| Quantity | 7 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.