Z-0727-2019Class II

Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272

Name: Z-0727-2019 Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272
Creator: Volcano Corporation
Published: 2018-10-17
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2018-10-17 / Terminated

FDA source

Volcano Corporation began a recall of 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... on 2018-10-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0727-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Posted: 2019-01-11
Terminated: 2021-04-30
Recalling firm: Volcano Corporation
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.
Product code: OBJ Catheter, Ultrasound, Intravascular
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 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 [email protected] 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0727-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11
Z-0727-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11

Product code OBJ

K153094Class IIVisions PV .035 Digital IVUS CatheterVolcano Corporation / cleared 2015-12-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)