ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and acceleromet
FDA device recall Z-0267-06 · posted 2005-12-02 · Terminated
Recall details
- Recalling firm
- ela Medical Llc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXY
- Quantity affected
- 7
- Distribution
- Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,
- Date initiated
- 2005-10-25
- Date posted
- 2005-12-02
- Date terminated
- 2007-01-28
- Location
- Plymouth, MN
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