The Recall Desk
HighFDA (Devices)·Z-1871-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects

Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.

What this means for you

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 is an FDA Class II recall of a medical device with a confirmed manufacturing defect (insufficient or incomplete welds) in a life-critical application. However, the source reports no illnesses or injuries, placing it at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic is recalling specific lots of the HY10Z48R2 Adult ECC 1/4 Custom Perfusion System, a sterile prescription medical device. The recalled lot (#220866332) consists of 6 tubing packs with a use-by date of September 29, 2022.

These specific lots may have been manufactured with insufficient or incomplete welds, which could affect the structural integrity and proper function of the device.

The product was distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas, with no distribution to foreign, government, or military entities.

The recalled product

Product
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Perfusion System
Hazard
Affected units
6

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 00763000292034
  • Lot #220866332
  • Use By 2022-09-29

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 →

Related recalls

Same manufacturer · Medtronic Perfusion Systems

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Same hazard · weld defect

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