Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device
FDA device recall Z-0801-05 · posted 2005-05-06 · Terminated
Recall details
- Recalling firm
- ela Medical Llc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 38 in US and 47 OUS
- Distribution
- AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
- Date initiated
- 2005-01-25
- Date posted
- 2005-05-06
- Date terminated
- 2006-07-22
- Location
- Plymouth, MN
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