Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Astra XT DR Implantable pulse generator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Astra XT DR Implantable pulse generator see related information
Date Initiated by Firm November 08, 2021
Create Date December 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-0391-2022
Recall Event ID 89054
PMA Number P920015 
Product Classification Pulse generator, permanent, implantable - Product Code NVZ
Product Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Code Information 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   
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Patient Services
800-551-5544
Manufacturer 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."
FDA Determined
Cause 2		 Error in labeling
Action On 09-Nov-2021, Medtronic initiated mailing the patient letter, including a corrected Medical Device Identification Card, to impacted patients. In addition, on 08-Nov-2021, physicians following impacted patients were sent a physician letter explaining the correction.
Quantity in Commerce 10 Medical Device Cards
Distribution US, Canada, Northern Mariana Islands
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-