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U.S. Department of Health and Human Services

Class 1 Device Recall Angioguard RX & Angioguard XP, Emboli Capture Guide Wire System

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 Class 1 Device Recall Angioguard RX & Angioguard XP, Emboli Capture Guide Wire Systemsee related information
Date Initiated by FirmMarch 24, 2023
Date PostedMay 11, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1484-2023
Recall Event ID 91922
510(K)NumberK220654 
Product Classification Temporary Carotid Catheter for Embolic Capture - Product Code NTE
ProductANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
Code Information UDI/DI 20705032054802; Lot Numbers: 35264208, 35264212, 35265329, 35265654, 35265649, 35265667.
FEI Number 1016427
Recalling Firm/
Manufacturer		 Cordis US Corp
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact
786-313-2000
Manufacturer Reason
for Recall		There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
FDA Determined
Cause 2		Vendor change control
ActionThe firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Return any affected product UPDATED 5/15/2023: The firm issued an updated letter dated 4/20/2023 since they extended the scope to include additional item and lot numbers, as well as removing some lot numbers. The remainder of the letter was similar to the initial letter dated 3/24/2023 and also contained a response form for return.
Quantity in Commerce684 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NTE
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