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U.S. Department of Health and Human Services

Class 2 Device Recall Visions PV .035 Digital IVUS Catheter

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  Class 2 Device Recall Visions PV .035 Digital IVUS Catheter see related information
Date Initiated by Firm October 17, 2018
Create Date January 11, 2019
Recall Status1 Terminated 3 on April 30, 2021
Recall Number Z-0727-2019
Recall Event ID 81882
510(K)Number K153094  
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
Product Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272

Product Usage:
The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.
Code Information Batch Numbers: 0301425755 0301418943 0301424426 0301420226 0301425756 0301425758 0301424427 0301418942 0301425757 0301430789 0301430790 0301430792 0301430791 0301420227 0301431656 0301431657 0301431658 0301438592 0301440863 0301438593 0301441405 0301441406 0301442658 0301446207 0301450813 0301450814 0301453531 0301457395 0301457396 0301457397 0301457398 0301465894 0301462001 0301462002 0301462003 0301465896 0301453530 0301465897 0301469598 0301469597 0301469599 0301453529 0301472646 0301472651 0301476733 0301492152 0301487364 0301487363 0301485883 0301485884 0301487964 0301487965 0301481405 0301492153 0301501411 
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Philips Complaint Department
800-228-4728 Ext. 3
Manufacturer Reason
for Recall		 Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm disseminated a Medical Device Advisory Notice by mail on 10/17/2018. The letter requested that the consignee notify the complaint department at 800-228-4728 Option 3 or email IGTD.CustomerInquiry@philips.com to report an ability to insert the guidewire into the catheter. The defective units will be replaced.
Quantity in Commerce 1240 units
Distribution Worldwide Distribution
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 = OBJ and Original Applicant = Volcano Corporation
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