Drug recall
ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape…
FDA recall event 74781 · Class II · Reshape Medical Inc
Key facts
| Event ID | 74781 |
|---|---|
| Recall numbers | Z-2552-2016 |
| Recalling firm | Reshape Medical Inc |
| Product type | Devices |
| Products | ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly error during… |
| Initiation date | May 4, 2016 |
| Report date | Aug 24, 2016 |
| Termination date | Aug 17, 2016 |
| City | San Clemente |
| State | CA |
| Country | United States |
| FEI number | 3007934906 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: