RegWardenFDA facility compliance records
Facility

SORIN GROUP ITALIA S.R.L

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2016: 1 inspections; 2017: 2 recalls; 2020: 1 recalls1’13’14’151’162’17’18’191’20’21’22’23’24’25’26
  • Recalls (4)
  • Inspections (1)

Devices registered here (1)

  • Accessory Equipment, Cardiopulmonary Bypass
    Product code KRI (opens in a new tab) · Class I · Cardiovascular · 21 CFR 870.4200

Recalls & enforcement

  • Class IITerminated2020-07-29
    LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perce…
  • Class IITerminated2017-07-24
    There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan,…
  • Class IITerminated2017-04-11
    Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
  • Class IITerminated2013-11-20
    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.

FDA inspections (1)

  • VAI2016-01-21
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SORIN GROUP ITALIA S.R.L (FEI 3005426550) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005426550-sorin-group-italia-s-r-l/

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