Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Summary
The FDA issued a Class II for Medical Device Identification Cards associated with Astra XT DR Implantable puls by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Reason: The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patie.
Details
Source
Device Recall
External ID
Z-0391-2022
Action Date
2021-12-22
Status
Terminated
Category
device
Product Description
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Lot/Code Info: Astra XT DR implantable pulse generator, Product Number/CFN X2DR01, UDI 00763000108953, Serial Numbers: RNH655287S, RNH648107S, RNH645452S, RNH634608S, RNH642593S, RNH638740S, RNH635040S, RNH636809S, RNH633755S UDI 00643169634671, Serial Numbers: RNH612514S
Quantity Affected: 10 Medical Device Cards
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-08
Company
Mounds View, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) have FDA actions?
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 138 FDA actions in our database, including 138 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0391-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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