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U.S. Department of Health and Human Services

Class 2 Device Recall VISTA BRITE TIP

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 Class 2 Device Recall VISTA BRITE TIPsee related information
Date Initiated by FirmFebruary 07, 2025
Date PostedMarch 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1330-2025
Recall Event ID 96272
510(K)NumberK021593 
Product Classification Catheter, percutaneous - Product Code DQY
ProductVista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Code Information UDI: 20705032042991/ Lot Number: 18368326
FEI Number 1016427
Recalling Firm/
Manufacturer		 Cordis US Corp
14201 Nw 60th Ave
Miami Lakes FL 33014-2802
For Additional Information ContactMiguel Avila
786-313-2000
Manufacturer Reason
for Recall		Catheter manufactured at the incorrect length.
FDA Determined
Cause 2		Employee error
ActionOn February 7, 2025 Cordis issued a Urgent Medical Device Recall notification to affected consignees via E-Mail. Cordis asked consignees to take the following actions: 1) Read this Urgent Medical Device Recall letter. 2) Immediately check your inventory for any units from the affected lot in your possession. 3. Identify and quarantine any units. Check all storage and usage locations. 3) Share this letter with others in your facility who need to be made aware of this recall and with any other facility. 4) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form or email to: GMB-CordisFieldAction@cordis.com 5) Return any affected product to the address listed on the form, with reference to your Customer Number which is listed on the form. 6) Maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice with the affected product.
Quantity in Commerce12 units
DistributionUS: WA OUS: Japan
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 = DQY
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