Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously int
FDA device recall Z-0864-2011 · posted 2011-01-06 · Terminated
Recall details
- Recalling firm
- Medtronic CardioVascular
- Reason for recall
- Needles may fail to retract and thus cause injury.
- Action taken
- Medtronic sent an Urgent Medical Device Safety Information letter to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Sales Representatives were to contact each account and complete an acknowledgement form indicating the Physicians had been notified. For questions regarding this recall customers were to contact their local representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 1,080 units
- Distribution
- Worldwide Distribution - USA, Germany, Netherlands, Slovakia, and Spain
- Date initiated
- 2010-04-30
- Date posted
- 2011-01-06
- Date terminated
- 2011-01-06
- Location
- Santa Rosa, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PIONEER PLUS CATHETER (K081804) | Medtronic, Inc. | 2008-08-05 |