Z-2718-2015Class II

Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions...

Name: Z-2718-2015 Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions...
Creator: Volcano Corporation
Published: 2015-07-22
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2015-07-22 / Terminated / root cause: manufacturing process

FDA source

Volcano Corporation began a recall of Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular... on 2015-07-22. FDA classified it as Class II and gives the reason as "Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2718-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Posted: 2015-09-02
Terminated: 2016-04-28
Recalling firm: Volcano Corporation
Product: Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.
Product code: PDU Catheter For Crossing Total Occlusions
Reason for recall: Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The Volcano Corporation sent an Urgent Medical Device Recall letter dated July 22, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine and return all affected product in their inventory. Customers were also asked to complete the attached form and fax back to 866-723-2482. Customers with questions were instructed to call 866-861-8923. For questions regarding this recall call 978-439-3586.
Quantity in commerce: 5042 devices
Distribution: Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
Product codes and lots: Product Code PPLUS20; All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2718-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2718-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02

Product code PDU

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)