NA HY2V10R33Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000299835), received between Feb 11, 2025 and Jan 29, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K171308); 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.

Recalls naming this device

1. Dec 12, 2022Open, Classified

   An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

   Z-1028-2023 · Root cause: Process change control · Recall details · FDA record ↗

2. Oct 12, 2021Open, Classified

   Product is labeled as non-pyrogenic but endotoxin testing was not performed.

   Z-0491-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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 29, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT TWO CUSTOM TUBING PACKS ARRIVED WITH DAMAGED OUTER PACKAGING, RESULTING IN A BREACH OF STERILITY. THE PACKS WERE NOT USED. BOTH PACKS WERE FROM THE SAME LOT NUMBER. THE PACKS WERE REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208961 ↗
• MalfunctionJan 29, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT TWO CUSTOM TUBING PACKS ARRIVED WITH DAMAGED OUTER PACKAGING, RESULTING IN A BREACH OF STERILITY. THE PACKS WERE NOT USED. BOTH PACKS WERE FROM THE SAME LOT NUMBER. THE PACKS WERE REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208947 ↗
• MalfunctionFeb 11, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PRIMING OF A CUSTOM TUBING PACK, A LACERATION WAS NOTICED IN THE RECIRCULATION LINE. THERE WAS ALSO A CRACK IN THE SAME LOCATION. THE RECIRCULATION LINE WAS DESCRIBED AS DAMAGED. THE SIZE OF THE CRACK WAS NOTED. IT WAS CONFIRMED THAT A COMPLETE CRACK OCCURRED. THERE WAS NO DAMAGE TO THE PACKAGING OR OTHER DEVICES IN THE SAME SHIPMENT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354220 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171308. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2018 · Jan 3, 2018 · Terminated
  Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.