Model Number L131, ESSENTIO DR EL MRI Pacemaker

Class I - Dangerous

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    GTIN 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 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  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Scientific Corporation
Reason for Recall:
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Model Number L131, ESSENTIO DR EL MRI Pacemaker

Product Codes/Lot Numbers:

GTIN 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 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Official Source

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View on FDA.gov

FDA Recall Number: Z-0097-2026

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