The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1878-2021·Announced 2021-06-23

Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

Medtronic is recalling specific lots of CB1H18R20 Custom Perfusion System tubing packs because they may have been 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 is an FDA Class II recall of a risk-of-harm product (cardiac perfusion equipment) with no reported illnesses or injuries. The hazard—insufficient or incomplete welds—is a real manufacturing defect affecting device integrity, not merely theoretical. Class II without reported hospitalizations combined with potential for serious harm during cardiac procedures justifies a High severity rating.

Plain-English summary

Medtronic Perfusion Systems is recalling specific lots of the CB1H18R20 Custom Pack, which is a sterile custom perfusion system used during cardiac procedures.

The recalled tubing packs may have been manufactured with insufficient or incomplete welds, which could affect the system's functionality and structural integrity.

Affected products were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas. The recall involves lot number 220776249 with a use-by date of July 6, 2022.

Healthcare facilities that received these tubing packs should discontinue use immediately and contact Medtronic Perfusion Systems for instructions on disposal or replacement.

The recalled product

Product
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac Perfusion System
Hazard
Affected units
4

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 00763000108328
  • Lot number 220776249
  • Use By 2022-07-06

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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