FDA Medical Device Recalls (openFDA)
Volcano Corporation: 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.
- Recall number
- Z-0726-2019
- Recalling firm
- Volcano Corporation
- 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.
- Status
- Terminated
- Initiated
- 2018-10-17
- Posted
- not on file
- Terminated
- 2021-04-30
- Reason
- 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.
- Root cause
- 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
- 6870 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K121273"]
- PMA numbers
- not on file
- Product code
- OBJ
- Firm FEI
- 2939520
- Firm city
- Rancho Cordova
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28