ela Medical Llc Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
Brand
ela Medical Llc
Lot Codes / Batch Numbers
AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099, AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102, AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197, AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146 OUS codes:AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069, AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111, AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186, AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283, AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441.
Products Sold
AK630187, AK630131, AK630076, AK630290, AK630173, AK630115, AK730368, AK630130, AK630167, AK630099, AK630106, AK730377, AK730393, AK730443, AK730363, AK630157, AK730442, AK630026, AK630135, AK630102, AK630226, AK630142., AK730431, AK630185, AK630137, AK630230, AK630147, AK630015, AK630030, AK630197, AK630098, AK730448, AK630090, AK630265, AK630160, AK730455, AK730381, AK630146 OUS codes:AK630029, AK630043, AK630045, AK630046, AK630048, AK630055, AK630066, AK630067, AK630069, AK630072, AK630073, AK630075, AK630078, AK630080, AK630083, AK630101, AK630104, AK630108, AK630111, AK630112, AK630121, AK630129, AK630154, AK630155, AK630172, AK630174, AK630175, AK630178, AK630186, AK630199, AK630207, AK630216, AK630221, AK630223, AK630231, AK630247, AK630280, AK630281, AK630283, AK630284, AK630296, AK630297, AK630298, AK630299, AK730435, AK730439, AK730441.
ela Medical Llc is recalling Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, t due to A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.
Recommended Action
Per FDA guidance
Angeion notified physicians responsible for managing each remaining implanted ICD, also provided them with programming means to change the automatic cap charging schedule, and to monitor and document the reprogramming process.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, GA, IL, IN, KY, MD, MA, MI, MN, NJ, NC, OH, PA
Page updated: Jan 10, 2026