Recall Weekly
Moderate riskFDA DeviceClass II

TransMedics OCS perfusion sets recalled for possible startup failure

TransMedics is recalling OCS Liver Perfusion Sets (model 3200, software rev 3) used for organ transport. The Perfusion Module may have an unprogrammed Front End Board, which can cause the OCS system to show an error message saying "Unsupported Perfusion Module Present" and block further use. No injuries have been reported.

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

What to do

  1. Set aside affected OCS Liver Perfusion Sets and contact TransMedics and your care team before using or discarding them.
  2. Check the serial numbers and expiration dates against the notice. It lists 15 serial numbers (for example 4470-4-22280 through 4470-4-24636), although it states 18 affected units.
  3. The notice does not specify a remedy; ask TransMedics how to get a replacement or return the affected sets.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
OCS Liver Perfusion Set Model/Catalog Number: 3200 Software Version: rev 3 OCS Liver Perfusion Module included in the Liver Perfusion Set used for organ transport.
Sold in
Nationwide
Made for
All ages (under 120 years)

This recall covers 3 products — see all of them.

Details

Units affected
18
Illnesses reported
None reported
Manufactured in
200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification
Class II
Recall number
Z-0381-2027

In the FDA's words

Description
OCS Liver Perfusion Set Model/Catalog Number: 3200 Software Version: rev 3 OCS Liver Perfusion Module included in the Liver 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 Set SN: 4470-4-24374; Description: OCS Liver Perfusion Set; EXP Date: 11/10/27; UDI: *+B00944705/$$+74470-4-24374/14D202711100*; 2. Perfusion Set SN: 4470-4-23845; Description: OCS Liver Perfusion Set; EXP Date: 10/23/27; UDI: *+B00944705/$$+74470-4-23845/14D202710235*; 3. Perfusion Set SN: 4470-4-24226; Description: OCS Liver Perfusion Set; EXP Date: 11/10/27; UDI: *+B00944705/$$+74470-4-24226/14D20271110$*; 4. Perfusion Set SN: 4470-4-24559; Description: OCS Liver Perfusion Set; EXP Date: 11/2/27; UDI: *+B00944705/$$+74470-4-24559/14D202711026*; 5. Perfusion Set SN: 4470-4-24636; Description: OCS Liver Perfusion Set; EXP Date: 11/2/27; UDI: *+B00944705/$$+74470-4-24636/14D202711022*; 6. Perfusion Set SN: 4470-4-24508; Description: OCS Liver Perfusion Set; EXP Date: 11/2/27; UDI: *+B00944705/$$+74470-4-24508/14D202711020*; 7. Perfusion Set SN: 4470-4-24384; Description: OCS Liver Perfusion Set; EXP Date: 11/2/27; UDI: *+B00944705/$$+74470-4-24384/14D202711022*; 8. Perfusion Set SN: 4470-4-23182; Description: OCS Liver Perfusion Set; EXP Date: 10/23/27; UDI: *+B00944705/$$+74470-4-23182/14D20271023%*; 9. Perfusion Set SN: 4470-4-23650; Description: OCS Liver Perfusion Set; EXP Date: 10/19/27; UDI: *+B00944705/$$+74470-4-23650/14D202710194*; 10. Perfusion Set SN: 4470-4-23593; Description: OCS Liver Perfusion Set; EXP Date: 10/19/27; UDI: *+B00944705/$$+74470-4-23593/14D20271019A*; 11. Perfusion Set SN: 4470-4-23471; Description: OCS Liver Perfusion Set; EXP Date: 10/19/27; UDI: *+B00944705/$$+74470-4-23471/14D202710195*; 12. Perfusion Set SN: 4470-4-22403; Description: OCS Liver Perfusion Set; EXP Date: 9/10/27; UDI: *+B00944705/$$+74470-4-22403/14D20270910+*; 13. Perfusion Set SN: 4470-4-22433; Description: OCS Liver Perfusion Set; EXP Date: 9/3/27; UDI: *+B00944705/$$+74470-4-22433/14D202709033*; 14. Perfusion Set SN: 4470-4-22303; Description: OCS Liver Perfusion Set; EXP Date: 8/20/27; UDI: *+B00944705/$$+74470-4-22303/14D20270820/*; 15. Perfusion Set SN: 4470-4-22280; Description: OCS Liver Perfusion Set; EXP Date: 8/20/27; UDI: *+B00944705/$$+74470-4-22280/14D202708201*; 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: 18
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.

More from TransMedics

See all

Related topics

SoftwareMedical devicesSold nationwideMore from FDA Device