Device recall
Z-0414-2024: TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in…
FDA device recall · Class II · Edwards Lifesciences, LLC
Key facts
| Recall number (Z-number) | Z-0414-2024 |
|---|---|
| Recall event | 93279 |
| Product | TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in (160cm); PXVMP3X32: x3… |
| Product code | DRS |
| Recalling firm | Edwards Lifesciences, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K142749, K181684, K183413 |
| FEI number | 2015691 |
At a glance
- 1–9 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