🔍 RecallPedia

Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Class I - Dangerous
🏥 Medical Devices Recalled: January 3, 2018 Medtronic Perfusion Systems Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    a) REF 2815R1, UPN/GTIN: 20885074191038, Lot/Serial Numbers: 210937492, 213151103, 213671744 b) REF 2D25R6, UPN/GTIN: 00613994268174, Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603, 210478517, 210591995, 210767149, 211011818, 211210404, 211243436, 211542842, 211761616 c) REF 9M68R, UPN/GTIN: 20643169876648, Lot/Serial Numbers: 212067087, 212796361 d) REF BB4B15R13, UPN/GTIN: 00643169845121, Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883, 212796215, 213248430, 213583108 e) REF BB4B15R14, UPN/GTIN: 00763000025878, Lot/Serial Numbers: 213801240, 213868837 f) REF BB9L72R, UPN/GTIN: 00643169845077, Lot/Serial Numbers: 211715103 g) REF BB9L72R1, UPN/GTIN: 00643169872127, Lot/Serial Numbers: 212020797, 212174623, 212193001, 212301586, 212355584, 212428238, 212626142, 212884370, 213001157, 213248459, 213631247, 213672934, 213802501, 214072742, 214093025 h) REF CB1Z87R11, UPN/GTIN: 00643169741591, Lot/Serial Numbers: 211755326 i) REF CB4L56R24, UPN/GTIN: 00643169735989, Lot/Serial Numbers: 211654744, 211654745, 211800954 j) REF CB4L56R26, UPN/GTIN: 00643169906181, Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166, 213358174, 213573495, 213623995, 214053395 k) REF CB5S68R3, UPN/GTIN: 20613994490760, Lot/Serial Numbers: 210937507 l) REF CB7X82R4, UPN/GTIN: 00643169471986, Lot/Serial Numbers: 211050766, 211320749 m) REF CB7X82R5, UPN/GTIN: 00643169789517, Lot/Serial Numbers: 211423503, 211443209, 211443210, 211885323, 211991293, 212154744, 212235237, 212274655, 212428312, 212473311, 212671632, 212962650, 213126447, 213292357, 213377926, 213445426, 213494394, 213494396, 213672914, 213906498, 214043035, 214093030 n) REF HY6Y19R5, UPN/GTIN: 00643169510432, Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742, 211846417, 212235012, 212545229, 212835348 o) REF HY8M65R2, UPN/GTIN: 00643169661295, Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066, 212355669, 213001001, 213719738 p) REF TL8W39R6, UPN/GTIN: 00643169715097, Lot/Serial Numbers: 210731697, 210838201, 210937704
  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:
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Product Codes/Lot Numbers:

a) REF 2815R1, UPN/GTIN: 20885074191038, Lot/Serial Numbers: 210937492, 213151103, 213671744 b) REF 2D25R6, UPN/GTIN: 00613994268174, Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603, 210478517, 210591995, 210767149, 211011818, 211210404, 211243436, 211542842, 211761616 c) REF 9M68R, UPN/GTIN: 20643169876648, Lot/Serial Numbers: 212067087, 212796361 d) REF BB4B15R13, UPN/GTIN: 00643169845121, Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883, 212796215, 213248430, 213583108 e) REF BB4B15R14, UPN/GTIN: 00763000025878, Lot/Serial Numbers: 213801240, 213868837 f) REF BB9L72R, UPN/GTIN: 00643169845077, Lot/Serial Numbers: 211715103 g) REF BB9L72R1, UPN/GTIN: 00643169872127, Lot/Serial Numbers: 212020797, 212174623, 212193001, 212301586, 212355584, 212428238, 212626142, 212884370, 213001157, 213248459, 213631247, 213672934, 213802501, 214072742, 214093025 h) REF CB1Z87R11, UPN/GTIN: 00643169741591, Lot/Serial Numbers: 211755326 i) REF CB4L56R24, UPN/GTIN: 00643169735989, Lot/Serial Numbers: 211654744, 211654745, 211800954 j) REF CB4L56R26, UPN/GTIN: 00643169906181, Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166, 213358174, 213573495, 213623995, 214053395 k) REF CB5S68R3, UPN/GTIN: 20613994490760, Lot/Serial Numbers: 210937507 l) REF CB7X82R4, UPN/GTIN: 00643169471986, Lot/Serial Numbers: 211050766, 211320749 m) REF CB7X82R5, UPN/GTIN: 00643169789517, Lot/Serial Numbers: 211423503, 211443209, 211443210, 211885323, 211991293, 212154744, 212235237, 212274655, 212428312, 212473311, 212671632, 212962650, 213126447, 213292357, 213377926, 213445426, 213494394, 213494396, 213672914, 213906498, 214043035, 214093030 n) REF HY6Y19R5, UPN/GTIN: 00643169510432, Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742, 211846417, 212235012, 212545229, 212835348 o) REF HY8M65R2, UPN/GTIN: 00643169661295, Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066, 212355669, 213001001, 213719738 p) REF TL8W39R6, UPN/GTIN: 00643169715097, Lot/Serial Numbers: 210731697, 210838201, 210937704

Distribution:

Distributed in: DE, IA, CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0535-2018

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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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