NA 11Y90R3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000852429), received between Mar 24, 2025 and Jan 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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

• MalfunctionJan 15, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK, IT WAS REPORTED THAT A HOLE WAS NOTED IN THE TYVEK LID OF THE CUSTOM PACK. THERE WAS NO DAMAGE TO THE OUTER PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087311 ↗
• MalfunctionMar 24, 2025Crack; Fluid/Blood Leak; Material Puncture/Hole; Crack; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A LEAK/CUT IN THE CUSTOM TUBING PACK, SPECIFICALLY IN THE 3/8 X 3/32 SEGMENT OF TUBING PRIOR TO USE. THE LEAK/CUT WAS WERE THE TUBING IS MARKED BY RED TAPE. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE CUSTOMER STATED THAT PATIENT BLOOD LOSS DID NOT OCCUR BECAUSE OF THE LEAK AND AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED BECAUSE OF THE BLOOD LOSS FROM THE LEAK THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676094 ↗

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-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
• Z-1879-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
• Z-1886-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, 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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, 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-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-1884-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, 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-1873-2021 · Apr 29, 2021 · Terminated
  Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
• Z-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
• Z-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, 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.

…and 10 more.