Affinity Pixie™ BBP211Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994617316), received between Apr 21, 2022 and May 7, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

16 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY PIXIE OXYGENATOR, IT WAS REPORTED THAT A LEAK WAS NOTED FROM THE TOP OF THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE. THE CUSTOMER STATED THAT THE LEAK WAS FOUND DURING WATER PRIMING. THERE WAS NO BLOOD LOSS AND NO TRANSFUSION REQUIRED AS THE LEAK OCCURRED DURING PRIMING. THERE WAS NO AIR IN THE SYSTEM/TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257979 ↗
• MalfunctionJul 11, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PIXIE OXYGENATOR, THE CUSTOMER REPORTED A BLOOD LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297280 ↗
• MalfunctionJun 7, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE AFFINITY PIXIE OXYGENATORS, IT WAS REPORTED BY A RESEARCHER THAT THE OXYGENATORS USED IN THEIR RESEARCH PROJECTS HAD MECHANICAL FAILURES WHEN USED WITHIN INLINE PERFUSION SYSTEMS FOR PIG LIVER AND PIG KIDNEY. THE FLOW RATES WERE BELOW 300 MMHG AND BETWEEN 30-60 MINUTES AFTER BEGINNING THE PROCESS, THE DEVICE WOULD FORM A CRACK AND CAUSE OUTWARD LEAKING. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURES. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER IS PART OF A RESEARCH GROUP WORKING ON PIG AND HUMAN LIVER PERFUSIONS. THE BREAKAGE OF ALL THE DEVICES WERE NOTICED WITHIN THE SAME WEEK OF EXPERIMENTS, BUT THE EXACT DATES ARE NOT AVAILABLE. THE CUSTOMER STATED THAT NO BLOOD WAS USED BUT THE SOLUTION USED DID LEAK SIGNIFICANTLY THROUGHOUT THE PERFUSION. THE CUSTOMER STATED THAT THE DEFECT WAS NOT VISIBLE, ONLY THROUGH THE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076769 ↗
• MalfunctionMay 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A PIXIE OXYGENATOR, IT WAS REPORTED THAT THERE WAS LEAK FROM THE TOP OF THE OXYGENATOR WHILE PRIMING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE (EX. DEVICES IN A TRAY OR CUSTOM PACK). THE CIRCUIT WAS PRIMED WITH BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019228 ↗
• MalfunctionApr 20, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY PIXIE OXYGENATOR, IT WAS REPORTED BY A RESEARCHER THAT THE OXYGENATORS USED IN THEIR RESEARCH PROJECTS HAD MECHANICAL FAILURES WHEN USED WITHIN INLINE PERFUSION SYSTEMS FOR PIG LIVER AND PIG KIDNEY. THE FLOW RATES WERE BELOW 300 MMHG AND BETWEEN 30-60 MINUTES AFTER BEGINNING THE PROCESS, THE DEVICE WOULD FORM A CRACK AND CAUSE OUTWARD LEAKING. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURES. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER IS PART OF A RESEARCH GROUP WORKING ON PIG AND HUMAN LIVER PERFUSIONS. THE BREAKAGE OF ALL THE DEVICES WERE NOTICED WITHIN THE SAME WEEK OF EXPERIMENTS, BUT THE EXACT DATES ARE NOT AVAILABLE. THE CUSTOMER STATED THAT NO BLOOD WAS USED BUT THE SOLUTION USED DID LEAK SIGNIFICANTLY THROUGHOUT THE PERFUSION. THE CUSTOMER STATED THAT THE DEFECT WAS NOT VISIBLE, ONLY THROUGH THE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775174 ↗
• MalfunctionApr 20, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY PIXIE OXYGENATOR, IT WAS REPORTED BY A RESEARCHER THAT THE OXYGENATORS USED IN THEIR RESEARCH PROJECTS HAD MECHANICAL FAILURES WHEN USED WITHIN INLINE PERFUSION SYSTEMS FOR PIG LIVER AND PIG KIDNEY. THE FLOW RATES WERE BELOW 300 MMHG AND BETWEEN 30-60 MINUTES AFTER BEGINNING THE PROCESS, THE DEVICE WOULD FORM A CRACK AND CAUSE OUTWARD LEAKING. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURES. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER IS PART OF A RESEARCH GROUP WORKING ON PIG AND HUMAN LIVER PERFUSIONS. THE BREAKAGE OF ALL THE DEVICES WERE NOTICED WITHIN THE SAME WEEK OF EXPERIMENTS, BUT THE EXACT DATES ARE NOT AVAILABLE. THE CUSTOMER STATED THAT NO BLOOD WAS USED BUT THE SOLUTION USED DID LEAK SIGNIFICANTLY THROUGHOUT THE PERFUSION. THE CUSTOMER STATED THAT THE DEFECT WAS NOT VISIBLE, ONLY THROUGH THE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775162 ↗
• MalfunctionApr 20, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY PIXIE OXYGENATOR, IT WAS REPORTED BY A RESEARCHER THAT THE OXYGENATORS USED IN THEIR RESEARCH PROJECTS HAD MECHANICAL FAILURES WHEN USED WITHIN INLINE PERFUSION SYSTEMS FOR PIG LIVER AND PIG KIDNEY. THE FLOW RATES WERE BELOW 300 MMHG AND BETWEEN 30-60 MINUTES AFTER BEGINNING THE PROCESS, THE DEVICE WOULD FORM A CRACK AND CAUSE OUTWARD LEAKING. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURES. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER IS PART OF A RESEARCH GROUP WORKING ON PIG AND HUMAN LIVER PERFUSIONS. THE BREAKAGE OF ALL THE DEVICES WERE NOTICED WITHIN THE SAME WEEK OF EXPERIMENTS, BUT THE EXACT DATES ARE NOT AVAILABLE. THE CUSTOMER STATED THAT NO BLOOD WAS USED BUT THE SOLUTION USED DID LEAK SIGNIFICANTLY THROUGHOUT THE PERFUSION. THE CUSTOMER STATED THAT THE DEFECT WAS NOT VISIBLE, ONLY THROUGH THE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16775140 ↗
• MalfunctionDec 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PIXIE OXYGENATOR, IT WAS REPORTED THAT A LEAK OCCURRED. THE DEVICE WAS REPLACED, BUT THE REST OF THE CUSTOM TUBING PACK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT EVENT OCCURRED AT THE BEGINNING OF THE PROCEDURE, WHILE ON BYPASS, BUT BEFORE X-CLAMP. THE AMOUNT OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK WAS BETWEEN 5 TO 10ML. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK. THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE. THERE WAS NO AIR IN THE SYSTEM/TUBING AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15938213 ↗
• InjuryOct 21, 2022Gas Output Problem; Increase in Pressure; Obstruction of Flow; Gas Output Problem; Increase in Pressure; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PIXIE OXYGENATOR, IT WAS REPORTED THAT THE CLINICIAN NOTED THERE WAS A DIFFERENCE BETWEEN THE 'DIALED IN' PUMP FLOW ON THE QUANTUM HEART AND LUNG MACHINE (HLM) CONTROLLER AND THAT ON THE ARTERIAL FLOW PROBE WHICH WAS LOCATED BETWEEN THE OXYGENATOR AND PATIENT. THE CLINICIAN WAS CONCERNED THERE WAS SOMETHING WRONG WITH BLOOD FLOW DELIVERY AND INCREASED THE OCCLUSION ON THE ROLLER PUMP. THEY FELT THE TUBING EXITING THE ROLLER PUMP (BETWEEN THE PUMP AND OXYGENATOR) AND DESCRIBED IT AS 'ROCK SOLID' TO THE TOUCH INDICATING HIGH PRESSURES. PRE-OXYGENATOR PRESSURES ARE NOT MEASURED. ON INCREASING FIO2 AS PER PROTOCOL FOR CYANOTIC CHILDREN, THE OXYGENATION DID NOT INCREASE AS EXPECTED AND THE CEREBRAL OXIMETRY STARTED TO DECREASE FROM 80 TO 40% (MASSIMO NIRS). INCREASING THE PUMP FLOW DID NOT RESULT IN INCREASED FLOW ON THE FLOW PROBE CLOSEST TO THE PATIENT AND MANUALLY PALPATED PRESSURE REMAINED GREAT IN THE TUBING. THE PATIENT WAS VENTILATED BY THE ANESTHETIST, BYPASS WAS TERMINATED AND THE OXYGENATOR WAS CHANGED OUT. BYPASS RECOMMENCED, THE TWO FLOWS MATCHED, PRESSURE IN THE TUBING WAS NORMAL AND OXYGENATION WAS WITHIN THE EXPECTED RAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15648383 ↗
• MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PIXIE OXYGENATOR, IT WAS REPORTED THAT THERE WAS A BLOOD LEAK NOTICED FROM THE TOP OF THE OXYGENATOR DURING CARDIOPULMONARY BYPASS FOR A PATIENT WITH CONGENITAL HEART DISEASE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE DEVICE, THE PACKAGING OR OTHER CONTENTS WITHIN THE PACKAGE (E.G. DEVICES IN A TRAY OR CUSTOM PACK). THE AMOUNT OF PATIENT BLOOD LOSS AND WHETHER A TRANSFUSION WAS REQUIRED WERE REQUESTED BUT THIS INFORMATION COULD NOT BE PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15638713 ↗
• MalfunctionJul 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PIXIE OXYGENATOR, IT WAS REPORTED THAT DURING EXTRACORPOREAL CIRCULATION, THE OXYGENATOR OOZED BLOOD. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOCATION OF THE LEAK WAS FROM ONE OF OXYGENATOR'S PORTS. THE CUSTOMER STATED THAT THERE WAS A SMALL AMOUNT OF BLOOD LOSS BUT NO SPECIFIC STATISTICS AND NO TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15075307 ↗
• InjuryApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PIXIE OXYGENATOR, THE CUSTOMER REPORTED THAT AFTER FOR 20 MINUTES ON CARDIOPULMONARY BYPASS, THE OXYGENATOR APPEARED TO SEEP BLOOD, AND THE DEVICE COULD NO LONGER BE USED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT IS STILL INCONCLUSIVE WHETHER THE ISSUE WILL AFFECT THE PATIENT, AND THE POSSIBILITIES SUCH AS INFECTION AND WATER INFLOW TO THE OXYGENATOR DURING THE REPLACEMENT PROCESS CANNOT BE RULED OUT. THE AMOUNT OF PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK WAS ASKED BUT UNKNOWN. A TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK. THE BLOOD LEAK OCCURRED FROM THE BOTTOM OF THE OXYGENATOR. THERE WAS NO DAMAGE TO THE PACKAGING OR THE DEVICE IDENTIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165666 ↗

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-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-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-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-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-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-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-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-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-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-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-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
• 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-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-1191-2021 · Feb 4, 2021 · Terminated
  Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardioto

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