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U.S. Department of Health and Human Services

Class 2 Device Recall ELA Rhapsody SR

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  Class 2 Device Recall ELA Rhapsody SR see related information
Date Initiated by Firm October 25, 2005
Date Posted December 02, 2005
Recall Status1 Terminated 3 on January 28, 2007
Recall Number Z-0267-06
Recall Event ID 34003
PMA Number P950029S017 
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
Product ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.
Code Information Rhapsody SR 2210 Serial numbers: 244WE078, 249WE059, 309WE066, 309WE145, 316WE215, 316WE233 AND 321WE080.
Recalling Firm/
Manufacturer		 ela Medical Llc
2950 Xenium Ln N Ste 120
Plymouth MN 55441-2623
Manufacturer Reason
for Recall		 Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.
FDA Determined
Cause 2		 Other
Action A Dear Doctor letter, dated 10/25/05, was sent to all affected doctors. The letter describes the failures and mentions that pacemaker depend patients implanted with devices manufactured in the first group could require prophylactic replacement.
Quantity in Commerce 7
Distribution Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
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 = DXY and Original Applicant = MicroPort CRM USA Inc.
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