Z-0267-06

ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and...

Name: Z-0267-06 ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and...
Creator: ela Medical Llc
Published: 2005-10-25
License: https://open.fda.gov/license/

Ela Medical, Inc. / initiated 2005-10-25 / Terminated / root cause: manufacturing process

FDA source

ela Medical Llc began a recall of ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene... on 2005-10-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0267-06
Status: Terminated
Initiated: 2005-10-25
Posted: 2005-12-02
Terminated: 2007-01-28
Recalling firm: Ela Medical, Inc.
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.
Product code: DXY Implantable Pacemaker Pulse-Generator
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.
Root cause tag: manufacturing process
FDA root cause: 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,
Product codes and lots: Rhapsody SR 2210 Serial numbers: 244WE078, 249WE059, 309WE066, 309WE145, 316WE215, 316WE233 AND 321WE080.

Product code DXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)