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U.S. Department of Health and Human Services

Class 2 Device Recall SMART PERFUSION PACK

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  Class 2 Device Recall SMART PERFUSION PACK see related information
Date Initiated by Firm June 29, 2017
Create Date July 29, 2017
Recall Status1 Terminated 3 on April 12, 2021
Recall Number Z-2798-2017
Recall Event ID 77810
510(K)Number K981613  
Product Classification Tubing, pump, cardiopulmonary bypass - Product Code DWE
Code Information Lot Number 1703700067 
Recalling Firm/
Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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.
Quantity in Commerce 1 unit
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWE and Original Applicant = COBE CARDIOVASCULAR, INC.