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 Intersept Custom Tubing Pack which contain Select 3D or Recalled by Medtronic Inc. Cardiac Rhythm Disease Management Due to Medtronic is recalling all models of its Select...

Date: January 30, 2014
Company: Medtronic Inc. Cardiac Rhythm Disease Management
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 Inc. Cardiac Rhythm Disease Management directly.

Affected Products

Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.

Quantity: 19483 total (7669 US, 11814 OUS)

Why Was This Recalled?

Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Inc. Cardiac Rhythm Disease Management

Medtronic Inc. Cardiac Rhythm Disease Management has 23 total recalls tracked by RecallDetector.

Related Recalls

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