Z-0805-2014Class II

ORCHESTRA/ORCHESTRA PLUS Programmer

Name: Z-0805-2014 ORCHESTRA/ORCHESTRA PLUS Programmer
Creator: Sorin Group Italia S.r.l.
Published: 2013-11-20
License: https://open.fda.gov/license/

Corcym Inc. / initiated 2013-11-20 / Terminated / root cause: software

FDA source

Sorin Group Italia S.r.l. began a recall of ORCHESTRA/ORCHESTRA PLUS Programmer on 2013-11-20. FDA classified it as Class II and gives the reason as "Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0805-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-20
Posted: 2014-01-22
Terminated: 2014-09-08
Recalling firm: Corcym Inc.
Product: ORCHESTRA/ORCHESTRA PLUS Programmer
Product code: LNX
Reason for recall: Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.
Root cause tag: software
FDA root cause: Software design
Action: On Nov 20 and Nov 25, 2013, the Dear Doctor Letter was sent by certified mail to 1,310 physicians who are following 13,003 patients implanted with a REPLU or ESPRIT pacemakers in the US. Sorin provided the following recommendations to the physicians: You should consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit. When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre. As a general rule, a maximum of 6 month follow-up interval when the battery impedance becomes greater than or equal to 3.5 k. This recommendation should also be followed subsequent to the installation of the new programmer software version.
Quantity in commerce: 1,718
Distribution: Nationwide.
Product codes and lots: ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0805-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0805-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-22

Product code LNX

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)