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U.S. Department of Health and Human Services

Class 2 Device Recall OCS Heart System

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 Class 2 Device Recall OCS Heart Systemsee related information
Date Initiated by FirmApril 18, 2025
Date PostedNovember 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0384-2027
Recall Event ID 100066
PMA NumberP180051 
Product Classification Organ care system (OCS) heart system - Product Code QIK
ProductOCS Heart System OCS Heart Perfusion Set Model/Catalog Number: 1200 OCS Heart Perfusion Sets containing OCS Heart Cardioplegia Arrest Set are components of perfusion set (or are available as separately shippable replacement accessories) intended to be used with the OCS console for organ transport
Code Information 1. Perfusion Set SN: 4822-6-20455; Description: Heart Perfusion Set; Accessory Kit Lot: 3646-4-732504; EXP Date: 2028-04-05; UDI: +B00948225/$$+74822-6-20455/14D202804055; 2. Accessory Set Lot: 3646-4-732504; Description: OCS Heart Cardioplegia Arrest Set; EXP Date: 2028-04-05; UDI: +B00936463/$$73646-4-732504/14D20280405G;
FEI Number 3003152463
Recalling Firm/
Manufacturer		 TransMedics, Inc.
200 Minuteman Rd Ste 302
Andover MA 01810-1046
For Additional Information ContactChristy Foreman
978-8098795
Manufacturer Reason
for Recall		Incorrectly assembled device kits that include incorrect components.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn or about April 18, 2026, "OCS Heart Cardioplegia Arrest Set", "OCS Heart Instrumentation Tool Set", and "OCS Liver Perfusion Initiation Set" letters were sent to customers. Actions to be taken: TransMedics requests that you return or discard any unused affected units to us at your convenience. Actions Taken by TransMedics We have shipped units to you to replace the affected product. If you have any questions, please contact myself at the number below, your local support representative, or TransMedics Customer Service by phone at +1 (978) 552-0999 (US), +31(0) 20-7084561 (EU) or email (recall@transmedics.com).
Quantity in Commerce5
DistributionWorldwide - US Nationwide distribution in the states of NE, AZ, CA, FL, GA, IL, MA, MI, MN, NC, NJ, OH, TX, UT, WA and the countries of Australia, France, Italy, Taiwan.
Total Product Life CycleTPLC 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.
PMA DatabasePMAs with Product Code = QIK
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