Agency classClass IIOur severity:High FDA (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.

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 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: incomplete-welds
manufacturing-defect
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 →

Same manufacturer · Medtronic Perfusion Systems

See all →

High
Arterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
Severe
Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
Severe
Medtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
High
Arterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
High
Arterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05

Same hazard · incomplete welds