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Terminated

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.

FDA Recall Z-0267-06 · Posted 2005-12-02

Recalling Firmela Medical Llc
Recall StatusTerminated
Product CodeDXY
Date Initiated2005-10-25
Date Terminated2007-01-28
Product Quantity7

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Devices distributed with the US to AZ, CA, FL, IL, LA, MA, ME, MO, MS, SC,

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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