| Class 2 Device Recall C315HIS Delivery Catheter | |
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
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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)
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Recalling Firm/ Manufacturer |
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 8200 Coral Sea St Ne Mounds View MN 55112-4391
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQY
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