Z-1844-2015Class II

Volcano PV .035 Catheter: Part number: 88901

Name: Z-1844-2015 Volcano PV .035 Catheter: Part number: 88901
Creator: Volcano Corporation
Published: 2015-06-04
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2015-06-04 / Terminated / root cause: labeling and UDI

FDA source

Volcano Corporation began a recall of Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels... on 2015-06-04. FDA classified it as Class II and gives the reason as "During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1844-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-06-25
Terminated: 2015-10-27
Recalling firm: Volcano Corporation
Product: Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.
Product code: OBJ Catheter, Ultrasound, Intravascular
Reason for recall: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory.
Quantity in commerce: 162 total devices (included both products)
Distribution: US Nationwide Distribution and one account in Canada.
Product codes and lots: Product number 88901; lot number 50002518

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1844-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1844-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25
Z-1845-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25

Product code OBJ

K121273Class IIVisions Pv .035 Ditital Ivus CatheterVolcano Corporation / cleared 2012-09-10

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)