Reshape Medical, Inc.
Country not established
- Devices
- 4
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Company details
- DUNS number
- 877283486
- [email protected]
- Phone
- 1-844-937-7372
FDA recalls
2016
- 14 Oct 2016 Z-0392-2017 Class II Terminated ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
- 4 May 2016 Z-2552-2016 Class II Terminated 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 manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.
Frequently asked questions
How many devices does RESHAPE MEDICAL, INC. have in the registry?
The registry currently lists 4 devices for RESHAPE MEDICAL, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list RESHAPE MEDICAL, INC.'s devices?
Among its 4 most recently registered devices, RESHAPE MEDICAL, INC. has devices listed in FDA GUDID (4 devices).
What risk classes do RESHAPE MEDICAL, INC.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for RESHAPE MEDICAL, INC.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for RESHAPE MEDICAL, INC.?
FDA recall records list 2 recalls initiated by RESHAPE MEDICAL, INC., the most recent initiated on 14 Oct 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from RESHAPE MEDICAL, INC. in the registry?
The most recently registered devices listed for RESHAPE MEDICAL, INC. include ReShape® Integrated Dual Balloon System RSM110, ReShape™ Integrated Dual Balloon System RSM101, ReShape™ Removal Catheter RSM210 and ReShape™ Valve Sealant RSM900.