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 Achieve Cables Recalled by Medtronic Inc. Due to 64 units of Achieve Electrical Cables were shipped...

Date: September 29, 2015
Company: Medtronic Inc.
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. directly.

Affected Products

Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment. Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart.

Quantity: 64 units

Why Was This Recalled?

64 units of Achieve Electrical Cables were shipped with a potential sterility breach.

Where Was This Sold?

This product was distributed to 17 states: AR, CA, CO, DE, GA, IA, KY, ME, MI, MN, NY, OH, PA, TN, TX, VA, DC

Affected (17 states)Not affected

About Medtronic Inc.

Medtronic Inc. has 85 total recalls tracked by RecallDetector.

Related Recalls

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