Affinity Pixie™ BBP241Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994617309), received between Aug 2, 2019 and Jan 21, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 FDA recall record name this device's identifier.

15 other recalls cover devices cleared under the same FDA submission (K100645, K183511, K203111); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 4, 2021Terminated

   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.

   Z-1191-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A PIXIE OXYGENATOR AND PIXIE CARDIOTOMY VENOUS RESERVOIR, IT WAS REPORTED THAT THE PACKAGING OF THE DEVICE WAS IN POOR CONDITION AND THE INTERNAL PACKAGING WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS DAMAGE TO THE PACKAGING WAS EXTERNAL AND INTERNAL AND THE STERILE POUCH IS ALSO COMPROMISED. THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE PACKAGING WAS DAMAGED BUT STILL SEALED. THE DEVICE WAS SEALED/LOCATED IN THE 'SEAL'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133008 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED DECREASED OXYGEN WHILE USING THE PIXIE OXYGENATOR. THE OXY WAS USED TO COMPLETE THE PROCEDURE WITH THE AID OF ANESTHESIA VENTILATION TO INCREASE OXYGENATION. THERE WAS NO ADVERSE PATIENT EFFECTS. NO PERFUSION RECORDS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100645, K183511, K203111. One submission often covers many models, so check the product and lot details in each record.

• Z-1027-2023 · Dec 12, 2022 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
• Z-1028-2023 · Dec 12, 2022 · Open, Classified
  Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
• Z-1026-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
• Z-1024-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
• Z-1023-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
• Z-1025-2023 · Dec 12, 2022 · Open, Classified
  Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
• Z-1192-2021 · Feb 4, 2021 · Terminated
  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 col
• Z-1196-2021 · Feb 4, 2021 · Terminated
  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 s
• Z-1195-2021 · Feb 4, 2021 · Terminated
  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
• Z-1193-2021 · Feb 4, 2021 · Terminated
  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 sin
• Z-1190-2021 · Feb 4, 2021 · Terminated
  Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/
• Z-1197-2021 · Feb 4, 2021 · Terminated
  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 dev
• Z-1198-2021 · Feb 4, 2021 · Terminated
  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 de
• Z-1199-2021 · Feb 4, 2021 · Terminated
  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 a
• Z-1194-2021 · Feb 4, 2021 · Terminated
  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 de