Medtronic Perfusion Systems: Medical Device Recall in 2021 - (Recall #: Z-1195-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

Product Classification:

Class I

Date Initiated: February 4, 2021

Date Posted: March 24, 2021

Recall Number: Z-1195-2021

Event ID: 87271

Reason for Recall:

Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

Status: Terminated

Product Quantity: 4 units

Code Information:

Description: CUSTOM PACK HY11B40R1 1/4 RESPIRATO. Model Number: HY11B40R1. GTIN: 00763000314231. Lot Number: 220911913.

Distribution Pattern:

Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam

Voluntary or Mandated:

Voluntary: Firm initiated