Boston Scientific Corporation recalls ACCOLADE DR Pacemaker
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
Lot / code information
- UDI
- 00802526559174, 00802526559181
- Serial #
100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020 101021 101022 101024 1010…Show all
100752 100892 100893 100931 100932 100938 100941 100980 100981 100982 100985 100986 100988 100989 100990 100991 100997 101000 101002 101004 101006 101014 101016 101017 101020 101021 101022 101024 101025 101033 101036 101037 101042 101043 101044 101046 101048 101050 101053 101059 101061 101067 101214 101218 101221 101223 101224 101225 101382 101388 101393 101400 101406 101409 101411 101412 101418 101423 101424 101427 101436 101438 101440 101442 101450 101454 101455 101457 101459 101466 101469 101472 101475 101492 101493 101494 101511 101523 101524 101525 101529 101533 101535 101537 101541 101543 101545 101546 101550 101553 101555 101559 101560 101564 101572 101575 101576 101577 101579 101581 101584 101585 101588 101590 101602 101603 101604 101605 101607 101609 101611 101619 101625 101633 101634 101637 101638 101640 101642 101644 101648 101654 101656 101659 101676 101684 101687 101700 101705 101706 101726 101741 101749 101767 101779 101788 101790 101796 101805 101823 101825 101841 101844 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Additional code information
17579 717580 717581 717582 717586 717589 717590 717595 717599 717601 717602 717610 717611 717612 717613 717615 717616 717618 717619 717620 717623 717626 717627 717628 717630 717632 717635 717638 717645 717646 717647 717661 717662 717663 717667 717668 717671 717673 717679 717685 717694 717695 717699 717706 717707 717711 717713 717714 717715 717717 717722 717723 717779 717780 717785 717786 717789 717790 717791 717793 717795 717798 717800 717803 717805 717806 717810 717811 717812 717813 717814 717821 717822 717823 717831 717837 717839 717840 717848 717852 717859 717861 717864 717866 717869 717870 717882 717883 717894 717895 717900 717901 717908 717909 717915 717921 717928 717930 717933 717937 717944 717945 717948 717952 717969 717976 717981 717989 718024 718029 718044 718047 718048 718054 718059 718060 718061 718068 718069 718071 718075 718078 718081 718083 718084 718090 718094 718095 718098 718099 718109 718111 718115 718116 718119 718121 718123 718124 718131 718138 718139 718142 718144 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What the firm is doing
The firm sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2024. The letter describes the product, problem and actions to be taken. The customers were instructed to promptly identify patients, if device enters Safety Mode, perform emergent replacement for patients who are at risk for harm, during replacement of a device in Safety Mode pacing inhibition should be anticipated during electrocautery. General prophylactic replacement is not recommended; schedule device replacement promptly when the longevity remaining reaches four (4) years or if the longevity remaining is less than 4 years, perform system follow-ups in accordance with the instructions for use and update patients records with letter to maintain awareness for the remaining service life of the device. If you have any questions regarding this information or would like to report a clinical event, contact your Boston Scientific representative or Technical Services. Supplement March 26, 2025, High-Level Overview of Recall Strategy: on 03/26/2025, BSC notified only those implanting and following clinicians responsible for the newly identified active advisory devices. The letter sent to these clinicians will be the original December 12, 2024, Product Advisory letter, however, the March 2025 communication included a cover letter stating that new devices were identified that should have been initially categorized in the Advisory population.
DistributionShow detailsHide
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0822-2025
- FDA device classification · LWPOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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