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Reshape Medical Recalls
2 recalls on record · August 24, 2016 to November 16, 2016 · Medical Devices
November 16, 2016Medical DevicesFDA
Reshape Medical Inc recalls ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape
Hazard: ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
August 24, 2016Medical DevicesFDA
Reshape Medical Inc recalls ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual
Hazard: 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.