Z-2552-2016Class II

ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape...

Name: Z-2552-2016 ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape...
Creator: Reshape Medical Inc
Published: 2016-05-04
License: https://open.fda.gov/license/

Medtimo, Inc. / initiated 2016-05-04 / Terminated / root cause: manufacturing process

FDA source

Reshape Medical Inc began a recall of 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... on 2016-05-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2552-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Posted: 2016-08-17
Terminated: 2016-08-17
Recalling firm: Medtimo, Inc.
Product: 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.
Product code: LTI Implant, Intragastric For Morbid Obesity
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A Dear Doctor letter dated May 4, 2016, was sent to all the customers to inform them that ReShape Medical is recalling ReShape Integrated Dual Balloon System, Gen 1 due to a suspected misalignment of the connection between the proximal balloon cap and the delivery catheter. The letter informs the customers that 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. Customers are informed of the planned field correction and if customers have any questions then they're instructed to contact ReShape Medical Customer Service at (844) 937-7374. For further questions please call (949) 429-6680 ext. 106
Quantity in commerce: 56 units
Distribution: US: Distribution to the states of : NY, OH and CA.
Product codes and lots: 160317-001, 160371-002, 160317-003, 160324-010.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2552-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2552-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17

Product code LTI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)