Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Reported: December 22, 2021 Initiated: November 8, 2021 #Z-0390-2022
Product Description
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."
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 187 Medical Device Cards
- Distribution
- US, Canada, Northern Mariana Islands
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 187 Medical Device Cards.
Why was this product 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."
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 22, 2021. Severity: Moderate. Recall number: Z-0390-2022.
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