The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1885-2021·Announced 2021-06-23

Medtronic perfusion tubing packs recalled for manufacturing weld defects

Medtronic recalls 11 packs of HY10Y54R4 Custom Perfusion System tubing manufactured with insufficient or incomplete welds. No injuries have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall involves a manufacturing defect in critical medical tubing with potential for equipment failure during procedures. No illnesses or injuries have been reported, making the hazard theoretical rather than documented. Per the rubric, theoretical hazards without reported harm score at most 3.

Plain-English summary

Medtronic Perfusion Systems is recalling 11 tubing packs of the HY10Y54R4 Custom Pack ECC PED 1/4 Custom Perfusion System. The product is used for extracorporeal circulation procedures.

Specific lots may have been manufactured with insufficient or incomplete welds. This manufacturing defect could affect the integrity and reliability of the tubing during medical procedures.

The affected product was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The recall involves Lot number 221387881 with a Use By date of October 21, 2022.

Patients and healthcare providers should contact Medtronic immediately if they have concerns about whether they possess affected product. No injuries or illnesses have been reported to date.

The recalled product

Product
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion Equipment
Hazard
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • GTIN 00763000306717
  • Lot number 221387881
  • Use By 2022-10-21

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 25 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 25 products in this recall →

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