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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 FirmMay 15, 2026
Date PostedNovember 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0380-2027
Recall Event ID 100063
PMA NumberP180051 
Product Classification Organ care system (OCS) heart system - Product Code QIK
ProductOCS Heart Perfusion Set Model/Catalog Number: 1200 Software Version: rev 3 Product Description: OCS Heart Perfusion Module, included in the Heart Perfusion Set used for organ transport.
Code Information 1. Perfusion Module SN: 4822-8-22505; Description: OCS Heart Perfusion Set ; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-8-22505/14D20290409C*; 2. Perfusion Module SN: 4822-8-23601; Description: OCS Heart Perfusion Set; EXP Date: 7/27/29; UDI: *+B00948225/$$+74822-8-23601/14D20290727D*; 3. Perfusion Module SN: 4822-8-22496; Description: OCS Heart Perfusion Set; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-8-22496/14D20290409L*; 4. Perfusion Module SN: 4822-8-23497; Description: OCS Heart Perfusion Set; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-8-23497/14D20290409N*; 5. Perfusion Module SN: 4822-8-22479; Description: OCS Heart Perfusion Set; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-8-22479/14D20290409M*; 6. Perfusion Module SN: 4822-8-22504; Description: OCS Heart Perfusion Set; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-8-22504/14D20290409B*; 7. Perfusion Module SN: 4822-8-23604; Description: OCS Heart Perfusion Set; EXP Date: 7/13/29; UDI: *+B00948225/$$+74822-8-23604/14D20290713B*; 8. Perfusion Module SN: 4822-8-23600; Description: OCS Heart Perfusion Set; EXP Date: 7/13/29; UDI: *+B00948225/$$+74822-8-23600/14D202907137*; 9. Perfusion Module SN: 4822-8-23499; Description: OCS Heart Perfusion Set; EXP Date: 7/13/29; UDI: *+B00948225/$$+74822-8-23499/14D20290713N*; 10. Perfusion Module SN: 4822-8-23602; Description: OCS Heart Perfusion Set; EXP Date: 7/13/29; UDI: *+B00948225/$$+74822-8-23602/14D202907139*; 11. Perfusion Module SN: 4822-8-23674; Description: OCS Heart Perfusion Set; EXP Date: 7/13/29; UDI: *+B00948225/$$+74822-8-23674/14D20290713I*; 12. Perfusion Module SN: 4822-8-22460; Description: OCS Heart Perfusion Set; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-8-22460/14D20290409C*; 13. Perfusion Module SN: 4822-8-23675; Description: OCS Heart Perfusion Set; EXP Date: 7/13/29; UDI: *+B00948225/$$+74822-8-23675/14D20290713J*; 14. Perfusion Module SN: 4822-8-22481; Description: OCS Heart Perfusion Set; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-8-22481/14D20290409F*; 15. Perfusion Module SN: 4822-9-22492; Description: OCS Heart Perfusion Set; EXP Date: 4/9/29; UDI: *+B00948225/$$+74822-9-22492/14D20290409I*;
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		The Perfusion Module may have an unprogrammed Front End Board (FEB) which will not allow the system to proceed beyond the initial startup process. The OCS system will display an error message saying Unsupported Perfusion Module Present and will prevent further system use.
FDA Determined
Cause 2		Process control
ActionOn or about May 15, 2026 and June 29, 2026 OCS Heart Perfusion Set Device Recall Direct Customer Notifications, OCS Liver Perfusion Set Device Recall Direct Customer Notifications, and OCS Lung Mission Critical Perfusion Set Device Recall Direct Customer Notifications, were sent to customers. Actions to be taken: TransMedics requests that you return any unused affected units to us at your convenience. Actions Taken by TransMedics We plan to ship replacement units to you to replace the affected product.
Quantity in Commerce6
DistributionWorldwide - US Nationwide distribution in the states of CA, FL, IL, MA, MN, NC, NE, NY, TX and the country of Serbia;.
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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