NA BB12A44RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000848118), received between Dec 18, 2023 and Jan 15, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 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 3 most recent of 3 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 PACK, IT WAS REPORTED THAT THE BOX WAS DAMAGED WHEN RECEIVED WITH DAMAGED PACKAGING RESULTING IN THE DEVICE NOT BEING STERILE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS NOT SEALED/LOCATED IN THE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087326 ↗
• MalfunctionApr 16, 2024Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF TWO CUSTOM TUBING PACK'S, IT WAS REPORTED THAT THE CUSTOMER REPORTED AIR BETWEEN CONNECTORS AND TUBING. SEE ATTACHED PHOTOS. THE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116838 ↗
• MalfunctionDec 18, 2023Component Missing; Material Deformation; Air/Gas in Device; Component Missing; Material Deformation; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK, THE CUSTOMER REPORTED THAT THERE WERE NO INTERVENTIONS PERFORMED BECAUSE OF THIS ISSUE. THE ARTERIAL LINE OF THE ATRIAL VENTRICULAR LOOP WAS CONNECTED TO A 3/8" X 1/4" CONNECTOR AND THE CONNECTOR WAS PLACED IN A GORTEX GRAFT THAT WAS SEWN TO THE AXILLARY ARTERY. AFTER 2 HOURS AND 53 MINS ON BYPASS THE PATIENT WAS REWARMED AND CROSS CLAMP WAS STILL ON, THE TUBING CAME OFF OF THE CONNECTOR. THE CUSTOMER WAS FORCED TO COME OFF BYPASS BRIEFLY TO RE-CONNECT THE TUBING. THE DEVICE WAS REPLACED. NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO LEAK WAS OBSERVED. THE CUSTOMER STATED THERE IS OFTEN AIR DETECTED IN THE PREMADE CONNECTIONS WITHIN THE TUBING PACKS. THE CUSTOMER FOCUSES QUITE A BIT OF ATTENTION ON REMOVING AIR BUBBLES THAT SEEM TO GET CAUGHT BETWEEN THE TUBING AND THE CONNECTORSON THE PREMADE CONNECTIONS. THAT IS HOW THIS "BLEB" WAS DETECTED. THE AREA OF CONCERN WAS ON THE INLET CONNECTOR OF THE ARTERIAL LINE FILTER. THERE WAS NO PATIENT BLOOD LOSS AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344150 ↗

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-1890-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, 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-1882-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, 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-1871-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, 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-1889-2021 · Apr 29, 2021 · Terminated
  Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
• Z-1874-2021 · Apr 29, 2021 · Terminated
  Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
• Z-1895-2021 · Apr 29, 2021 · Terminated
  Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, 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-1887-2021 · Apr 29, 2021 · Terminated
  Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
• Z-1883-2021 · Apr 29, 2021 · Terminated
  Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
• Z-1875-2021 · Apr 29, 2021 · Terminated
  Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, 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.

…and 10 more.