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U.S. Department of Health and Human Services

Class 2 Device Recall Rhythm Xience Guider Catheter Introducer

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  Class 2 Device Recall Rhythm Xience Guider Catheter Introducer see related information
Date Initiated by Firm February 25, 2020
Date Posted April 23, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-1768-2020
Recall Event ID 85197
510(K)Number K170373  
Product Classification Introducer, catheter - Product Code DYB
Product Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Code Information Affected Lot Numbers/Expiration Date: 19040503 /April 2020 19052007 /May 2020 19061317 /June 2020
Recalling Firm/
Manufacturer		 Acutus Medical Inc
2210 Faraday Ave Ste 100
Carlsbad CA 92008-7225
For Additional Information Contact Steven McQuillan
442-232-6080
Manufacturer Reason
for Recall		 It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
FDA Determined
Cause 2		 Process design
Action The firm mailed a "Urgent: Medical Device Recall notification" letter to affected consignees on February 25, 2020 and March 5, 2020. In addition to informing consignees about the recalled product, the recall notification asked consignees to take the following actions: 1. Please immediately identify and quarantine any unused product and return this product to your Acutus Medical Representative immediately. Replacement product will be provided in approximately one month at no additional cost. 2. Please also kindly complete the acknowledgement form found on Page 3 of this letter and return the acknowledgement to Acutus Medical using the self-addressed stamped envelope. 3. For additional information regarding the issue discussed above, please contact Steven McQullan at 442-232-6080 or contact your local Acutus Medical Representative directly.
Quantity in Commerce 108 units
Distribution US: CA,SC, AZ OUS: None
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Rhythm Xience, Inc. (RXI)
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