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.
This recall has been terminated (originally issued December 2, 2005).
- Company
- Ela Medical Llc
- Recall Initiated
- October 25, 2005
- Posted
- December 2, 2005
- Terminated
- January 28, 2007
- Recall Number
- Z-0267-06
- Quantity
- 7
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
Lot / Code Info
Rhapsody SR 2210 Serial numbers: 244WE078, 249WE059, 309WE066, 309WE145, 316WE215, 316WE233 AND 321WE080.
Root Cause
Other
Action Taken
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.