Agency classClass IIOur severity:High FDA (Devices)·Z-1893-2021·Announced 2021-06-23

Medtronic Custom Perfusion System Tubing Packs Recalled Due to Welding Defects

Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.

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 medical device with structural defects (incomplete welds) that pose a risk of harm. No illnesses or injuries have been reported, placing this at the high-risk category for risk-of-harm products where injury has not yet occurred.

Plain-English summary

Medtronic Perfusion Systems is recalling 26 tubing packs from its BB7D76R13 Custom Perfusion System (Lot 221148857, use-by date October 12, 2022) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.

The affected tubing packs are sterile, prescription medical devices distributed in the United States in Alabama, Arizona, California, Indiana, Kentucky, Massachusetts, Ohio, Tennessee, and Texas.

Healthcare facilities and practitioners using affected lots should discontinue use and contact Medtronic Perfusion Systems for replacement product and further instructions. Patients or family members with questions about whether they were treated with the affected product should consult their healthcare provider.

The recalled product

Product: Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
Manufacturer: Medtronic Perfusion Systems
Category: Medical Device — Perfusion System
Hazard: incomplete-welds
structural-defect
Affected units: 26

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 00643169984820
Lot 221148857
Use By 2022-10-12

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

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Same hazard · incomplete welds