Lower risk Medical device recall · FDA · Published February 4, 2021

Medtronic Perfusion Systems Infant Tubingset Recall: Bacterial Endotoxin Risk

Medtronic recalls infant tubingsets due to potential bacterial endotoxin levels that could cause acute inflammatory responses in patients. Affected units include specific model and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1193-2021Medical device Medtronic Perfusion Systems ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088

✎ GovInfoNow plain-language explainer

Medtronic is recalling infant tubingsets that may contain elevated bacterial endotoxins. This could lead to acute inflammatory responses in patients using the device. The recall affects specific model numbers and lot ranges. Read more at govinfonow.com/recall/63305-medtronic-perfusion-systems-infant-tubingset-recall-bacterial-endotoxin-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63305-medtronic-perfusion-systems-infant-tubingset-recall-bacterial-endotoxin-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1193-2021

Cite this page

“Medtronic Perfusion Systems Infant Tubingset Recall: Bacterial Endotoxin Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63305-medtronic-perfusion-systems-infant-tubingset-recall-bacterial-endotoxin-risk. Based on FDA recall #Z-1193-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1193-2021%22&limit=1).

The FDA announced on Feb. 4, 2021, that Medtronic Perfusion Systems is recalling the Affinity Pixie Cardiotomy/Venous Reservoir due to potentially elevated bacterial endotoxin levels. Patients exposed to these levels may develop an acute inflammatory response.

How to tell if you have it

Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie
Model Number: M483203D
GTIN: 00613994931627
Lot Numbers: 220781539 and 220887101

The hazard

The products are being recalled due to potentially elevated levels of bacterial endotoxin. Patients exposed to these elevated levels may develop an acute inflammatory response.

Context

GovInfoNow's records show Medtronic Perfusion Systems has had 31 other recalls on record since June 22, 2017. Other recent recalls of similar products include Medtronic Pediatric Cannula Recall (May 25, 2026), Medtronic Octopus Evolution Tissue Stabilizer Model TS2000 Recall (May 12, 2026), and Medline Medical Kits Recall (July 8, 2026).

How to tell if you have this one

Check for the model number M483203D on the tubingset packaging. The affected lot numbers are 220781539 and 220887101. These units were sold with the specific product description.

Brand
Medtronic Perfusion Systems
Product
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie
Category
Medical device

FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
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

Recall number	Product, codes & lots	Quantity
Z-1190-2021	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).; 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*.	2,374 units
Z-1191-2021	Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). 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).; Description: OXYGENATOR BBP241 W/CVR NI BB STERILE. Model Number: BBP241. GTIN: 20613994617303. Lot Number: 13340434.	57 units
Z-1192-2021	Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). 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).; Description: CUSTOM PACK HY10J00R6 ECC SMALL CAR. Model Number: HY10J00R6. GTIN: 00763000304928. Lot number: 220768819.	3 units
Z-1193-2021	Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 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).; Description: PERFUSION M483203D 1/B. Model Number: M483203D. GTIN: 00613994931627. Lot Numbers: 220781539 and 220887101.	14 units
Z-1194-2021	Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 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).; Description: PERFUSION M448036B 1/B. Model Number: M448036B. GTIN: 00763000239855. Lot Number: 220798975.	10 units
Z-1195-2021	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).; Description: CUSTOM PACK HY11B40R1 1/4 RESPIRATO. Model Number: HY11B40R1. GTIN: 00763000314231. Lot Number: 220911913.	4 units
Z-1196-2021	Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). 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).; Description: CUSTOM PACK BB10H89R4 ECLR. Model Number: BB10H89R4. GTIN: 00763000126315. Lot Number: 220265395.	70 units
Z-1197-2021	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).; Description: PERFUSION M490817B 1/B. Model Number: M490817B. GTIN: 00643169096271. Lot Number: 220886950.	5 units
Z-1198-2021	Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 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).; Description: PERFUSION M484901D 1/B. Model Number: M484901D. GTIN: 00763000240288. Lot Number: 220906731.	4 units
Z-1199-2021	Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). 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).; Description: CUSTOM PACK BB7W03R8 CCSM NEON. Model Number: BB7W03R8. GTIN: 00643169990562. Lot Number: 220911945.	7 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number M483203D and lot numbers 220781539 or 220887101 on the tubingset packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

Feb 4, 2021Firm started the recall
Mar 17, 2021FDA classified it Class I
Mar 24, 2021Published in FDA’s Enforcement Report
Apr 26, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Medtronic Perfusion Systems recalls

Link to this recall

<a href="https://govinfonow.com/recall/63305-medtronic-perfusion-systems-infant-tubingset-recall-bacterial-endotoxin-risk">Medtronic Perfusion Systems Infant Tubingset Recall: Bacterial Endotoxin Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1193-2021 (February 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1193-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.