Device recall
Z-0954-2007: Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with…
FDA device recall · Class III · Possis Medical, Inc
Key facts
| Recall number (Z-number) | Z-0954-2007 |
|---|---|
| Recall event | 37919 |
| Product | Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System). |
| Product code | MCX |
| Recalling firm | Possis Medical, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 15, 2007 |
| PMA numbers | P989937 |
| FEI number | 2183460 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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