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Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.

Class I - Dangerous
🏥 Medical Devices Recalled: December 12, 2022 Medtronic Perfusion Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model BB841; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169354869 (Lot Numbers: 13384637, 13385152, 13385470, 13385745, 13385981, 13386194, 13386335, 13386747, 13386941, 13387068, 13387247, 13387298, 13387483, 13387670, 13387792, 13388008, 13388227, 13389074, 13389305, 13389823, 13389827, 13390010, 13390330, 13390505, 13390516, 13390751, 13391244, 13391264, 13391564, 13392146, 13392253, 13392727, 13393000, 13393036, 13393583, 13393871, 13394240, 13394370, 13394371, 13394424, 13394642, 13394972, 13395023, 13395803, 13395855, 13395924, 13396141, 13396262, 223431961, 223431962, 223476434, 223476435, 223525108, 223525109, 223525110, 223662140, 223662141, 223662142, 223662143, 223662144, 223746776, 223748866, 223751647, 223753656, 223753657, 223753658, 223753659, 223779522, 223782425, 223785172, 223790984, 223799185, 223800819, 223800886, 223806602, 223808121, 223812498, 223834087, 223834088, 223834089, 223834090, 223923171, 224046843, 224049195, 224060623, 224062467, 224071460, 224078980, 224087129, 224097013, 224169153, 224173725, 224180684, 224189083, 224198472, 224207770, 224217125, 224229400, 224229401, 224351135, 224384707, 224391477, 224401622, 224414139, 224428547, 224434720, 224459327, 224465687, 224469080, 224555817, 224562193, 224568610, 224571733, 224582640, 224591854, 224600536, 224609441, 224620065, 224629824, 224673589, 224673593, 224694993, 224702972, 224715756, 224722879, 224730837, 224736123, 224746679, 224754722, 224772850, 224772851, 224772852, 224772853, 224772854, 224772855, 224772856, 224772857, 224772858, 224772859, 224772860, 224772861, 224772862, 224772863, 224772864, 224772865, 224772886, 224772887, 224772889, 224772890, 224772891, 224772892, 224772893, 224772895, 224772896, 224772897, 225020112, 225209644, 225209645, 225210026, 225332480, 225332481, 225332482, 225332483); GTIN Number: 00643169354883 (Lot Numbers: 13384723, 13384730, 13384881, 13384976, 13385583, 13385767, 13385867, 13386228, 13386478, 13388449, 13388452, 13388544, 13388598, 13389191, 13389598, 13389870, 13390168, 13390640, 13390684, 13390874, 13390984, 13391365, 13391390, 13391663, 13391937, 13392221, 13392464, 13392614, 13392903, 13392975, 13393065, 13393176, 13393342, 13393342, 13393658, 13393890, 13393921, 13394029, 13394151, 13394821, 13395330, 13395332, 13395410, 13395461, 13395524, 13395771, 223388884, 223392415, 223392423, 223392435, 223431964, 223431965, 223431986, 223476436, 223476437, 223476438, 223476439, 223476439, 223476440, 223523220, 223523221, 223523222, 223523223, 223523224, 223523225, 223525106, 223525107, 223637178, 223641990, 223650772, 223660380, 223662145, 223662186, 223662187, 223662188, 223662189, 223662190, 223662191, 223723553, 223738421, 223750562, 223753660, 223753661, 223753662, 223753663, 223753664, 223753967, 223755426, 223755427, 223755428, 223833251, 223833256, 223834091, 223834092, 223834093, 223834094, 223834095, 223834096, 223872428, 223878290, 223878291, 223883408, 223893771, 223898271, 223903420, 223905400, 223913345, 223914588, 223928428, 223936394, 223939036, 223947101, 223953209, 223961794, 223964866, 223972811, 223981604, 223995093, 223995666, 224000958, 224006521, 224006951, 224011284, 224011625, 224011646, 224011647, 224011648, 224011649, 224011650, 224101106, 224236728, 224253937, 224312807, 224323095, 224331329, 224334991, 224346525, 224356382, 224356383, 224372815, 224475835, 224478783, 224484698, 224494813, 224506201, 224511441, 224518515, 224526165, 224526860, 224532203, 224535429, 224544419, 224630603, 224630604, 224644422, 224673817, 224686850, 224763409, 224771068, 224772898, 224772899, 224772900, 224772901, 224772902, 224772903, 224772904, 224772905, 224772926, 224772927, 224772928, 224772929, 224772930, 224772931, 224772932, 224772933, 224772935, 224772936, 224772937, 224772940, 224772942, 224772943, 224772944, 224772945, 224772986, 225090558, 225090559, 225090560, 225162245, 225162946, 225174904, 225174905, 225176086, 225294537, 225294539, 225294541, 225294543, 225294544, 225332485, 225332486, 225332487, 225332488, 225332489); GTIN Number: 00643169588660(Lot Numbers: 13385981, 13387247, 13387483, 13387792, 13389305, 13389823, 13389827, 13390516, 13390751, 13391244, 13391564, 13394370, 13394424, 13395924, 223476434, 223662140, 223662144, 223961794, 224087129, 224401622, 224526860, 224772929, 225020112, 225090559, 225162245, 225162946)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Perfusion Systems
Reason for Recall:
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.

Product Codes/Lot Numbers:

Model BB841; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169354869 (Lot Numbers: 13384637, 13385152, 13385470, 13385745, 13385981, 13386194, 13386335, 13386747, 13386941, 13387068, 13387247, 13387298, 13387483, 13387670, 13387792, 13388008, 13388227, 13389074, 13389305, 13389823, 13389827, 13390010, 13390330, 13390505, 13390516, 13390751, 13391244, 13391264, 13391564, 13392146, 13392253, 13392727, 13393000, 13393036, 13393583, 13393871, 13394240, 13394370, 13394371, 13394424, 13394642, 13394972, 13395023, 13395803, 13395855, 13395924, 13396141, 13396262, 223431961, 223431962, 223476434, 223476435, 223525108, 223525109, 223525110, 223662140, 223662141, 223662142, 223662143, 223662144, 223746776, 223748866, 223751647, 223753656, 223753657, 223753658, 223753659, 223779522, 223782425, 223785172, 223790984, 223799185, 223800819, 223800886, 223806602, 223808121, 223812498, 223834087, 223834088, 223834089, 223834090, 223923171, 224046843, 224049195, 224060623, 224062467, 224071460, 224078980, 224087129, 224097013, 224169153, 224173725, 224180684, 224189083, 224198472, 224207770, 224217125, 224229400, 224229401, 224351135, 224384707, 224391477, 224401622, 224414139, 224428547, 224434720, 224459327, 224465687, 224469080, 224555817, 224562193, 224568610, 224571733, 224582640, 224591854, 224600536, 224609441, 224620065, 224629824, 224673589, 224673593, 224694993, 224702972, 224715756, 224722879, 224730837, 224736123, 224746679, 224754722, 224772850, 224772851, 224772852, 224772853, 224772854, 224772855, 224772856, 224772857, 224772858, 224772859, 224772860, 224772861, 224772862, 224772863, 224772864, 224772865, 224772886, 224772887, 224772889, 224772890, 224772891, 224772892, 224772893, 224772895, 224772896, 224772897, 225020112, 225209644, 225209645, 225210026, 225332480, 225332481, 225332482, 225332483); GTIN Number: 00643169354883 (Lot Numbers: 13384723, 13384730, 13384881, 13384976, 13385583, 13385767, 13385867, 13386228, 13386478, 13388449, 13388452, 13388544, 13388598, 13389191, 13389598, 13389870, 13390168, 13390640, 13390684, 13390874, 13390984, 13391365, 13391390, 13391663, 13391937, 13392221, 13392464, 13392614, 13392903, 13392975, 13393065, 13393176, 13393342, 13393342, 13393658, 13393890, 13393921, 13394029, 13394151, 13394821, 13395330, 13395332, 13395410, 13395461, 13395524, 13395771, 223388884, 223392415, 223392423, 223392435, 223431964, 223431965, 223431986, 223476436, 223476437, 223476438, 223476439, 223476439, 223476440, 223523220, 223523221, 223523222, 223523223, 223523224, 223523225, 223525106, 223525107, 223637178, 223641990, 223650772, 223660380, 223662145, 223662186, 223662187, 223662188, 223662189, 223662190, 223662191, 223723553, 223738421, 223750562, 223753660, 223753661, 223753662, 223753663, 223753664, 223753967, 223755426, 223755427, 223755428, 223833251, 223833256, 223834091, 223834092, 223834093, 223834094, 223834095, 223834096, 223872428, 223878290, 223878291, 223883408, 223893771, 223898271, 223903420, 223905400, 223913345, 223914588, 223928428, 223936394, 223939036, 223947101, 223953209, 223961794, 223964866, 223972811, 223981604, 223995093, 223995666, 224000958, 224006521, 224006951, 224011284, 224011625, 224011646, 224011647, 224011648, 224011649, 224011650, 224101106, 224236728, 224253937, 224312807, 224323095, 224331329, 224334991, 224346525, 224356382, 224356383, 224372815, 224475835, 224478783, 224484698, 224494813, 224506201, 224511441, 224518515, 224526165, 224526860, 224532203, 224535429, 224544419, 224630603, 224630604, 224644422, 224673817, 224686850, 224763409, 224771068, 224772898, 224772899, 224772900, 224772901, 224772902, 224772903, 224772904, 224772905, 224772926, 224772927, 224772928, 224772929, 224772930, 224772931, 224772932, 224772933, 224772935, 224772936, 224772937, 224772940, 224772942, 224772943, 224772944, 224772945, 224772986, 225090558, 225090559, 225090560, 225162245, 225162946, 225174904, 225174905, 225176086, 225294537, 225294539, 225294541, 225294543, 225294544, 225332485, 225332486, 225332487, 225332488, 225332489); GTIN Number: 00643169588660(Lot Numbers: 13385981, 13387247, 13387483, 13387792, 13389305, 13389823, 13389827, 13390516, 13390751, 13391244, 13391564, 13394370, 13394424, 13395924, 223476434, 223662140, 223662144, 223961794, 224087129, 224401622, 224526860, 224772929, 225020112, 225090559, 225162245, 225162946)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1024-2023

Related Recalls

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Medtronic Perfusion Systems

Class I - Dangerous

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

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