The Recall Desk
HighFDA (Devices)·Z-1875-2021·Announced 2021-06-23

Medtronic Custom Perfusion System Tubing Packs Recalled for Incomplete Welds

Medtronic recalls Custom Perfusion System tubing packs due to incomplete welds in the manufacturing process that may affect device integrity.

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 involving a manufacturing defect (incomplete welds) in a sterile medical device used in critical medical procedures. No illnesses, injuries, or device failures are reported, but the structural defect in a risk-of-harm product meets the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Perfusion Systems is recalling 27 tubing packs for its Custom Perfusion System (model HY7M07R6, Custom Pack HY7M07R6 E 1/4, Sterile, Rx). Specific lots of this medical device were manufactured with insufficient or incomplete welds.

The incomplete welds represent a manufacturing defect that may compromise the structural integrity and proper function of the tubing system during use in critical medical procedures.

The recalled lots are 220866430 (Use By April 3, 2022), 221102361 (Use By April 3, 2202), and 221727287 (Use By September 29, 2022). These units were distributed nationwide in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

No specific guidance was provided in the recall notice regarding actions for individuals or healthcare providers who may have received these products. For additional information, contact Medtronic Perfusion Systems or the FDA.

The recalled product

Product
Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Surgical / Perfusion Equipment
Hazard
Affected units
27

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 (7)

  • GTIN 00643169981102
  • Lot numbers 220866430
  • Use By 2022-04-03
  • 221102361
  • Use By 2202-04-03
  • and 221727287
  • 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 →

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