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Moderate riskFDA DeviceClass II

TransMedics OCS Heart Perfusion Set recalled for incorrect components

TransMedics is recalling certain OCS Heart Perfusion Sets (Model 1200) that were incorrectly assembled and include incorrect components. The sets are used with the OCS console for organ transport. The recall covers 5 units, and the FDA has classified it as Class II.

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

What to do

  1. Set aside any affected units: Perfusion Set SN 4822-6-20455, or Accessory Set Lot 3646-4-732504 (OCS Heart Cardioplegia Arrest Set), both with expiration date 2028-04-05.
  2. Contact TransMedics for next steps. The notice doesn't specify a remedy or replacement process.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
OCS 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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
5
Illnesses reported
None reported
Manufactured in
200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification
Class II
Recall number
Z-0384-2027

In the FDA's words

Description
OCS 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 Incorrectly assembled device kits that include incorrect components. 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; Distribution: Worldwide - 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. Affected quantity: 5
Hazard
Incorrectly assembled device kits that include incorrect components.

3 products in this recall

TransMedics OCS perfusion sets recalled for incorrect components

TransMedics recalled three OCS products: the OCS Heart Perfusion Set (Model 1200), the OCS Liver Perfusion Set (Model 3200), and the OCS Heart Instrumentation Tool Set (Model 1401). The FDA says the device kits were incorrectly assembled and include incorrect components. The recall was distributed nationwide in the US (NE, AZ, CA, FL, GA, IL, MA, MI, MN, NC, NJ, OH, TX, UT, WA) and in Australia, France, Italy and Taiwan. No injuries have been reported.

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

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