FDA Medical devices recall ·
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0824-2025
- Date
- (initiated December 12, 2024)
- Company / brand
- Boston Scientific Corporation
4100 Hamline Ave N, Saint Paul, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 156,329 units (59,937 US, 96,792 OUS) in total
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Why was it recalled?
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
L101 - UDI-DI: 00802526558924 and 00802526558931, 00802526576317, 00802526576812, Serial Numbers: 100683 100690 100697 100701 100702 100703 100705 100706 100723 100724 100726 100727 100735 100740 100741 100762 100792 101029 101217 101364 101367 101370 101385 101392 101404 101408 101425 101428 101441 101480 101498 101499 101512 101558 101566 101570 101578 101595 101624 101673 101680 101694 101716 101721 101724 101731 101732 101742 101747 101757 101774 101775 101777 101784 101793 101799 101801 101810 101813 101830 101832 101836 101845 101854 101859 101860 101861 101863 101865 101870 101871 101874 101880 101898 101902 101903 101914 101921 101933 101936 101939 101950 101952 101956 101960 101961 101969 101971 101976 101993 102000 102001 102005 102021 102029 102037 102038 102041 102046 102060 102062 102069 102075 102077 102099 102103 102120 102127 102168 102174 102181 102212 102219 102225 102234 102249 102272 102275 102402 102403 102412 102433 102457 102466 102504 102537 102541 102568 102600 102607 102615 102616 102627 102645 102648 102650 102660 102679 102681 102684 102686 102693 102698 102707 102722 102723 102747 102749 102754 102757 102758 102763 102772 102784 102790 102793 102804 102807 102809 102813 102818 102819 102824 102831 102835 102849 102851 102857 102905 102918 102932 102934 102938 102939 102940 102941 102947 102951 102972 102975 102982 102983 102989 102995 103004 103006 103015 103017 103020 103081 103083 103095 103102 103106 103116 103120 103127 103135 103145 103147 10
Distribution
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0824-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.