Moderate riskFDA DeviceNov 6, 2026Class II

TransMedics OCS Heart Perfusion Set recalled for possible startup error

TransMedics is recalling OCS Heart Perfusion Sets, model 1200, software rev 3, and the notice lists 15 affected serial numbers. The Perfusion Module may have an unprogrammed Front End Board, which can stop the system after startup and show an "Unsupported Perfusion Module Present" error. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All TransMedics recalls

What to do

Check each Perfusion Module's serial number and expiration date against the list in the notice.
Contact TransMedics and your transplant care team about any affected module before using it.
The notice doesn't specify a remedy; ask TransMedics for instructions on repair or replacement.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: OCS 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.
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected: 6
Illnesses reported: None reported
Manufactured in: 200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification: Class II
Recall number: Z-0380-2027

In the FDA's words

Description: OCS 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. 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. 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*; Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, IL, MA, MN, NC, NE, NY, TX and the country of Serbia;. Affected quantity: 6
Hazard: 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.

3 products in this recall

TransMedics OCS perfusion sets recalled for possible startup failure

TransMedics is recalling three OCS organ perfusion sets used for organ transport: the OCS Heart Perfusion Set (Model 1200, software rev 3), the OCS Liver Perfusion Set (Model 3200, software rev 3), and the OCS Lung Mission Critical Plus Perfusion Set (Model 2200, software rev 1). The perfusion module in these sets may have an unprogrammed Front End Board, which can stop the system from getting past startup and cause it to show the error "Unsupported Perfusion Module Present." The notice says the product was distributed worldwide, including nationwide in the US in several states and in Serbia, and reports no injuries.

The agency lists each product separately. Check every one you might have.

OCS Heart Perfusion Set Model/Catalog Number: 1200 Software Version: rev 3 Product Description: OCS Heart Perfusion Module, included in the Heart Perfu… (this page)
Z-0380-2027 · 6
OCS Liver Perfusion Set Model/Catalog Number: 3200 Software Version: rev 3 OCS Liver Perfusion Module included in the Liver Perfusion Set used for org…
Z-0381-2027 · 18
OCS Lung Mission Critical Plus Perfusion Set Model/Catalog Number: 2200 Software Version: rev 1 OCS Lung MC+ Perfusion Module included in the Lung MC+ Per…
Z-0382-2027 · 1