Medtronic Perfusion Systems: Medical Device Recall in 2021 - (Recall #: Z-1190-2021)

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 Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). 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-1190-2021

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: 2,374 units

Code Information:

Description: OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU. Model Number: BBP241. GTIN: 20613994746508 and ***UPDATE GTIN 00643169089037***: Lot Numbers: 13344059, 13337110, 13337675, 13339043, 13339133, 13339290, 13339452, 13339527, 13344325, 13344487, 13344594, 13344819, 13346564, 13346733, 13347774, 13347907, 13347974, 13348151, 13348285, 13348909, 13348974, 13349283, 13349388, 13349517, 13349775, 13352983, 13353438, 13353541, 13353701, 13353800, 13337512, 13340766, 13342814, 13346440, 13348521, 13349141, 13352832, 13353163, ***UPDATE 13340871***.

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