CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
ReShape Integrated Dual Balloon System, Gen recalled by Reshape Medical
Reshape Medical is recalling ReShape Integrated Dual Balloon System, Gen 1, distributed in California, New York, Ohio. The recall was initiated on 4 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2552-2016
- FDA event ID
- 74781
- Recalling firm
- Reshape Medical, San Clemente, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2016
- FDA classified
- 17 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 4 May 2016 | Recall initiated by company | |
| 17 Aug 2016 | Classified by FDA | +105 days |
| 24 Aug 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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 and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
Where it was distributed
US: Distribution to the states of : NY, OH and CA.
Questions about this recall
Is ReShape Integrated Dual Balloon System, Gen 1 recalled?
Yes. Reshape Medical recalled ReShape Integrated Dual Balloon System, Gen 1 on 4 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2552-2016.
Why was it recalled?
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.
Which lots are affected?
160317-001, 160371-002, 160317-003, 160324-010.
Where was it sold?
US: Distribution to the states of : NY, OH and CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Reshape Medical
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ReShape Integrated Dual Balloon System, Gen recalled by Reshape Medical | Reshape Medical | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |