Boston Scientific Corporation recalls ESSENTIO 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.
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Lot / code information
- UDI
- 00802526558924 and 00802526558931, 00802526576317, 00802526576812
- Serial #
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 1014…Show all
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Additional code information
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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-0824-2025
- 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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- Process control
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination