Events

Recall of Device Recall SMART PERFUSION PACK, INSPIRE 8S

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77810
  • Event Risk Class
    Class 2
  • Event Number
    Z-2794-2017
  • Event Initiated Date
    2017-06-29
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157951
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tubing, pump, cardiopulmonary bypass - Product Code DWE
  • Reason
    Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are included with livanova perfusion tube sets (pts) which were then distributed to customers.
  • Action
    The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017. The actions to be taken by the customer: 1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs. 2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure. 3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack. 4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack. 5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices. 6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.

Device

Device Recall SMART PERFUSION PACK, INSPIRE 8S
  • Model / Serial
    Lot Number 1717300032
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA