NA HY7Y30R18Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00763000489472), received between Aug 25, 2023 and Feb 4, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (36 reports).

25 other recalls cover devices cleared under the same FDA submission (K171979); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257060 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257032 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256946 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256925 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256867 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256828 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256660 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256599 ↗
• MalfunctionFeb 4, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256577 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248720 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248671 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248581 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248447 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248344 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248280 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248220 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248109 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246867 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246797 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246242 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245986 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245760 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245623 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245533 ↗
• MalfunctionFeb 3, 2026Delivered as Unsterile Product; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACKS, THAT THE RED TUBING ON ONE SIDE OF THE AV LOOP AT THE SITE OF THE FOAM HOLDER WAS LOOSE AND IT COULD SLIDE IN AND OUT OF THE AV LOOP CLAMSHELL. THE SLICED PIECE OF TUBING THAT GOES AROUND THE 3/8" TUBING WAS NOT IN PLACE, WHICH ALLOWED MOVEMENT. THE LOOSE COMPONENTS DID NOT FALL INTO A PATIENT. THE STERILE BARRIER WAS DAMAGED ON SOME OF THE DEVICES. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE ALSO DAMAGED FOR SOME OF THE DEVICES. IT WAS STATED THAT ALL OF THE SAME ITEMS HAD THE SAME ISSUE JUST DIFFERENT BOXES. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS A STERILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171979. One submission often covers many models, so check the product and lot details in each record.

• Z-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1876-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
• Z-1887-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
• Z-1885-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1880-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
• Z-1893-2021 · Apr 29, 2021 · Terminated
  Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
• Z-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
• Z-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
• Z-1877-2021 · Apr 29, 2021 · Terminated
  Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.
• Z-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
• Z-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1889-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.

…and 10 more.