Home / Recalls / Sorin Group Italia S.r.l. / Z-0805-2014

Z-0805-2014 Class II Terminated

Recalled by Sorin Group Italia S.r.l. — Saluggia, VC

Recall Details

Product Type
Devices
Report Date
January 29, 2014
Initiation Date
November 20, 2013
Termination Date
September 8, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,718

Product Description

ORCHESTRA/ORCHESTRA PLUS Programmer

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.

Distribution Pattern

Nationwide.

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

Other recalls by Sorin Group Italia S.r.l.

  • Z-2985-2020 Class II — Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE (July 29, 2020)
  • Z-2987-2020 Class II — Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, C (July 29, 2020)
  • Z-2984-2020 Class II — Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, C (July 29, 2020)
  • Z-2988-2020 Class II — Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: (July 29, 2020)
  • Z-2986-2020 Class II — Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE (July 29, 2020)