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U.S. Department of Health and Human Services

Class 2 Device Recall EnTrust DR ICD

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  Class 2 Device Recall EnTrust DR ICD see related information
Date Initiated by Firm March 06, 2012
Date Posted March 22, 2012
Recall Status1 Terminated 3 on July 27, 2012
Recall Number Z-1250-2012
Recall Event ID 61356
PMA Number P980016S046 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 55432 USA.
Code Information all serial numbers
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact Medtronic Technical Services
800-723-4636
Manufacturer Reason
for Recall		 A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.
FDA Determined
Cause 2		 Device Design
Action An "Urgent Medical Device Correction" letter was sent to physicians beginning 3/6/2012. The letter described the issue and provided patient management recommendations. Additionally the letter stated that ongoing updates to the product performance report will be posted on a Medtronic website.
Quantity in Commerce 68,804 devices worldwide
Distribution Worldwide Distribution -- USA, and the countries of: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
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 = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.
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