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U.S. Department of Health and Human Services

Class 1 Device Recall Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir With Balance Biosurface

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  Class 1 Device Recall Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir With Balance Biosurface see related information
Date Initiated by Firm February 04, 2021
Date Posted March 17, 2021
Recall Status1 Open3, Classified
Recall Number Z-1197-2021
Recall Event ID 87271
510(K)Number K183511  
Product Classification Reservoir, blood, cardiopulmonary bypass - Product Code DTN
Product Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is
a single-use device designed to collect and store blood during extracorporeal
circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing
with the venous blood, which is filtered. The primary blood-contacting surfaces
of the CVR are coated with Balance Biosurface to reduce platelet activation and
adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
Code Information Description: PERFUSION M490817B 1/B. Model Number: M490817B. GTIN: 00643169096271. Lot Number: 220886950.
Recalling Firm/
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Customer Service
Manufacturer Reason
for Recall
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
FDA Determined
Cause 2
Process control
Action A written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. Consignees will also be asked to return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at800-854-3570 to initiate a product return.
Quantity in Commerce 5 units
Distribution Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DTN and Original Applicant = Medtronic Inc