Z-1197-2021Class I

Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie...

Name: Z-1197-2021 Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie...
Creator: Medtronic Perfusion Systems
Published: 2021-02-04
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2021-02-04 / Terminated / root cause: design

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface... on 2021-02-04. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1197-2021
Classification: Class I
Status: Terminated
Initiated: 2021-02-04
Posted: 2021-03-17
Terminated: 2024-04-26
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). 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 code: DTN Reservoir, Blood, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: A written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete the enclosed Customer Confirmation Form and email to [email protected]. Consignees will also be asked to return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at800-854-3570 to initiate a product return.
Quantity in commerce: 5 units
Distribution: 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
Product codes and lots: Description: PERFUSION M490817B 1/B. Model Number: M490817B. GTIN: 00643169096271. Lot Number: 220886950.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1197-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1190-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1191-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1192-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1193-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1194-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1195-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1196-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1197-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1198-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17
Z-1199-2021	Class I	Terminated	Voluntary: Firm initiated	2021-03-24	2021-03-17

Product code DTN

K183511Class IIAffinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)Medtronic, Inc. / cleared 2019-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)