Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: Th
FDA device recall Z-2718-2015 · posted 2015-09-02 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- PDU
- Quantity affected
- 5042 devices
- Distribution
- Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
- Date initiated
- 2015-07-22
- Date posted
- 2015-09-02
- Date terminated
- 2016-04-28
- Location
- Rancho Cordova, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PIONEER PLUS CATHETER, MODEL PLUS 120 (K101777) | Medtronic Vascular | 2010-07-23 |
| PIONEER PLUS CATHETER (K081804) | Medtronic, Inc. | 2008-08-05 |