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U.S. Department of Health and Human Services

Class 2 Device Recall Angeion Sentinel ICD

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  Class 2 Device Recall Angeion Sentinel ICD see related information
Date Initiated by Firm January 25, 2005
Date Posted May 06, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0802-05
Recall Event ID 31539
PMA Number P970024 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 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.
Code Information BE650129, BE650026 and BE650027. OUS: BE650038 and BE650002
Recalling Firm/
Manufacturer		 ela Medical Llc
2950 Xenium Ln N Ste 120
Plymouth MN 55441-2623
For Additional Information Contact Christina Doty
763-519-9411
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 3 in US and 2 OUS
Distribution AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = MicroPort CRM USA, Inc.
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