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U.S. Department of Health and Human Services

Class 2 Device Recall C315HIS Delivery Catheter

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  Class 2 Device Recall C315HIS Delivery Catheter see related information
Date Initiated by Firm September 09, 2021
Create Date October 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-0173-2022
Recall Event ID 88688
510(K)Number k101885  
Product Classification Catheter, percutaneous - Product Code DQY
Product C315-HIS Delivery Catheter
Code Information GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)
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
800-638-1991
Manufacturer Reason
for Recall		 Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
FDA Determined
Cause 2		 Under Investigation by firm
Action Written notification letter titled, "MEDICAL DEVICE RECALL C315HIS DELIVERY CATHETER" was sent to all consignees on 09/09/2021 via 2-day UPS delivery. The letter instructs the consignee to take the following actions: "Check your inventory for the catheters identified in Table 1 above. If the product has been consumed, please complete the enclosed Customer Confirmation Form and email to xxxxx@medtronic.com. No further actions are required. " If there is unused identified product in your inventory, quarantine and return it to Medtronic. Contact Medtronic Customer Service at xxxxxxx to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. o Note: Root cause is under investigation for this issue. Return of the identified product will aid the investigation. Please complete the enclosed Customer Confirmation Form and email to xxxxxx@medtronic.com." The letter also instructs the consignee to share the notice with all those who need to be made aware with their organization or to any organization where the potentially affected products have been transferred.
Quantity in Commerce 591 units
Distribution Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = MEDTRONIC INC.
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