Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic Bio-Medicus Insertion Kits Recalled by Medtronic Perfusion Systems Due to There was a label mix-up between two model...

Date: September 13, 2021
Company: Medtronic Perfusion Systems
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Perfusion Systems directly.

Affected Products

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

Quantity: 168 kits

Why Was This Recalled?

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Perfusion Systems

Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report