| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00862-1 |
| Product Name/Description |
Euphora Semi-Compliant Rapid Exchange Balloon Dilatation Catheter
Lot Number range: 212553130 to 213283557
Expiration Date range: 4 Jan 2019 to 9 May 2019
Multiple Model Numbers
ARTG Number: 238388 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has received reports of difficulties in removing the stylette of the Euphora Semi-Compliant Rapid Exchange (RX) Balloon Dilatation Catheter. In the event that stylette removal difficulties are encountered, there is the potential for damage to the balloon or catheter due to excessive force being applied, and this may lead to balloon inflation or deflation challenges.
Potential risks associated with balloon inflation and deflation difficulties include prolonged procedure time and the need for additional intervention. In addition, inflation or deflation difficulties or catheter damage during procedural use could result in vessel occlusion or injury. Medtronic has received one report of patient injury related to this matter. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requesting customers:
1. Identify and quarantine all unused affected product as listed in your inventory;
2. Return all unused, affected product listed in your inventory to Medtronic. Contact Customer Service on 1800 668 670 to initiate a product return and credit. Your Medtronic Representative can assist you in the return of affected product as necessary; and
3. Complete the supplied Customer Acknowledgement Form and fax it to Medtronic on 1800 929 645 to the attention of ANZ Regulatory Affairs or scan and email to rs.anzregaffairs@medtronic.com with TGA Ref # “RC-2017-RN-XXXXX-X” in the subject line.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1800 777 808 - Medtronic 24 Hour Helpline |