Device recall
Z-1773-2019: CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model…
FDA device recall · Class III · Cardiocommand Inc.
Key facts
| Recall number (Z-number) | Z-1773-2019 |
|---|---|
| Recall event | 82803 |
| Product | CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm - Acceleration of heart rate as an alternative to exercise or drugs during… |
| Product code | LPA |
| Recalling firm | Cardiocommand Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 12, 2021 |
| PMA numbers | P860008 |
| FEI number | 1927197 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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