FDA recall Z-0390-2022

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

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

Reason for recall

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."

Distribution

US, Canada, Northern Mariana Islands

Key facts

Status: Terminated
Initiation date: 2021-11-08
Report date: 2021-12-22
Termination date: 2026-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0390-2022