Device recall
Z-0392-2017: ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog…
FDA device recall · Class II · Reshape Medical Inc
Key facts
| Recall number (Z-number) | Z-0392-2017 |
|---|---|
| Recall event | 75475 |
| Product | ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one… |
| Product code | LTI |
| Recalling firm | Reshape Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 24, 2017 |
| PMA numbers | P140012, P140012S002 |
| FEI number | 3013508647 |
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