Class II — Potential Health Hazard

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

Medical Device Identification Cards associated with Sprint Quattro Lead Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to The back of some Medical Device Identification Cards...

Date: November 8, 2021
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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 Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.

Affected Products

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

Quantity: 187 Medical Device Cards

Why Was This Recalled?

The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

Where Was This Sold?

US, Canada, Northern Mariana Islands

About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.

Related Recalls

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