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Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
The FDA is aware that Bolton Medical has issued an Urgent Medical Device Recall (Removal) recommending that certain devices be removed from where they are used or sold. Affected devices:
- Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above.
Bolton Medical stated that in some cases the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. This failure mode is not able to be recognized until it occurs during the procedure.
Difficulties in releasing the stent graft may result in delay of procedure, stent graft displacement, and an inability to release the stent graft. This may require conversion to open surgical repair to release the clasp and can result in patient death. Please be advised that this failure mode can occur without prior warning and no device-based bailout method has been identified for this specific scenario.
The recommendations provided by the manufacturer have changed.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Terumo Aortic at Market_Actions-TMC@terumomedical.com.
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