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 DLP Femoral Arterial Cannula Recalled by Medtronic Perfusion Systems Due to Medtronic is recalling select lots of DLP Femoral...

Date: June 12, 2015
Company: Medtronic Perfusion Systems
Status: Terminated
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 DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator components utilize tip indicator bands for minimum tip alignment of the component parts. The cannula body is marked for depth insertion. The components are designed to fit over each other to progressively dilate the vessel during insertion. The dilator allows a 0.1-cm (0.038-in) guidewire to pass through it to aid in insertion. A soft, tapered transition fitting terminates in a 0.95-cm (3/8-in) connection site or barbed connector.

Quantity: 1304 devices

Why Was This Recalled?

Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.

Where Was This Sold?

This product was distributed to 17 states: AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, WI

Affected (17 states)Not affected

About Medtronic Perfusion Systems

Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.

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