Sorin Group Italia S.r.l.: Medical Device Recall in 2014 - (Recall #: Z-0805-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ORCHESTRA/ORCHESTRA PLUS Programmer

Product Classification:

Class II

Date Initiated: November 20, 2013

Date Posted: January 29, 2014

Recall Number: Z-0805-2014

Event ID: 67013

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.

Status: Terminated

Product Quantity: 1,718

Code Information:

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

Distribution Pattern:

Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated