Reshape Medical Recalls ReShape Integrated Dual Balloon System Due to Assembly Error
Reshape Medical Inc. is recalling 56 units of the ReShape Integrated Dual Balloon System because a manufacturing assembly error may cause saline leakage during inflation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential device malfunction (saline leakage) during a medical procedure, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Reshape Medical Inc. is recalling 56 units of the ReShape Integrated Dual Balloon System, Gen 1 (Catalog No. RSM110, Model No. 01-0013-001). The device is indicated for weight reduction in obese patients with a Body Mass Index (BMI) of 30 to 40 kg/m2 who have failed weight reduction with diet and exercise alone.
The recall is due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. This possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.
The affected units were distributed to the states of New York, Ohio, and California. The specific lot codes associated with this recall are 160317-001, 160371-002, 160317-003, and 160324-010.
The recalled product
- 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…
- Manufacturer
- Reshape Medical Inc
- Affected units
- 56
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 160317-001
- 160371-002
- 160317-003
- 160324-010.
Distribution
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