NA BB8V35R8Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000827885), received between Jan 20, 2026 and Mar 25, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE OUTER PACKAGING OF THE TWO CUSTOM TUBING PACKS WAS DAMAGED PRIOR TO USE. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE DEVICES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A HUGE TEAR WAS OBSERVED ON THE BOX AND STERILE BARRIERS. IT WAS STATED THAT THE DEVICES STAYED IN THE "SEAL AREA."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685574 ↗
• MalfunctionMar 3, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE OUTER PACKAGING OF THE CUSTOM TUBING PACK WAS DAMAGED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A HUGE TEAR WAS OBSERVED ON THE BOX AND STERILE BARRIER. THE DEVICE STAYED IN THE "SEAL AREA.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495209 ↗
• MalfunctionJan 29, 2026Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACKS, IT WAS REPORTED THAT THE OUTER PACKAGING WAS DAMAGED. THE DEVICES WERE NOT USED. 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. THE CUSTOMER WAS UNSURE IF THE STERILE SEAL WAS INTACT. THE DEVICE WAS PARTIALLY SEALED/LOCATED IN THE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208787 ↗
• MalfunctionJan 29, 2026Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM PACKS, IT WAS REPORTED THAT THE OUTER PACKAGING WAS DAMAGED. THE DEVICES WERE NOT USED. 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. THE CUSTOMER WAS UNSURE IF THE STERILE SEAL WAS INTACT. THE DEVICE WAS PARTIALLY SEALED/LOCATED IN THE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208755 ↗
• MalfunctionJan 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE OF THE CUSTOM TUBING PACK, THE DEVICE WAS RECEIVED WITH DAMAGE TO THE OUTER PACKAGING, RESULTING IN A BREACH OF STERILITY. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE DEVICE WAS NOT USED, AND IT WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116671 ↗

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-1891-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
• Z-1878-2021 · Apr 29, 2021 · Terminated
  Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, 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-1894-2021 · Apr 29, 2021 · Terminated
  Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, 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-1872-2021 · Apr 29, 2021 · Terminated
  Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
• Z-1881-2021 · Apr 29, 2021 · Terminated
  Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, 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-1889-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, 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-1888-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.

…and 10 more.