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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-0726-2019
Recall Event ID 81882
510(K)Number K121273  
Product Classification Catheter, ultrasound, intravascular - Product Code OBJ
Product Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173

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: 0301438588 0301450806 0301457390 0301457394 0301461995 0301487960 0301457393 0301450808 0301435421 0301442654 0301446201 0301469590 0301469593 0301442649 0301446202 0301476726 0301480937 0301485800 0301465886 0301498206 0301420742 0301485801 0301441407 0301469591 0301465885 0301476727 0301450809 0301480927 0301453527 0301440822 0301450812 0301453524 0301461996 0301476725 0301480928 0301492147 0301422648 0301450811 0301461999 0301450810 0301430794 0301430795 0301446203 0301472637 0301430796 0301465887 
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 6870 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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