Device recall
Z-2302-2013: NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model…
FDA device recall · Class II · Medtronic Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-2302-2013 |
|---|---|
| Recall event | 66334 |
| Product | NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange… |
| Product code | LOX |
| Recalling firm | Medtronic Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2014 |
| PMA numbers | P790017, P790017S095 |
| FEI number | 3001452571 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database