CanadaBolton Medical’s RelayPro Thoracic Stent‑Graft System is affected; it may be recognized during deployment by a lack of resistance when sliding the apex holder back and a failure to release the proximal stent because the proximal clasp can disconnect from the outer control tube. The graft can become unclaspable and the implant cannot be recaptured; Bolton received four complaints, three of which resulted in death. Contact the manufacturer for additional information.
What's being recalled
Companies: Bolton Medical, Inc., 799 International Parkway, Sunrise, Florida, United States, 33325.
How to identify it
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-38-109-38U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-40-114-40U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-40-204-36U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-40-204-40U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-46-164-42U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-46-259-42U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-34-154-34U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-40-154-36U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-44-209-40U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-44-259-40U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-32-209-28U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-34-154-30U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-34-259-34U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-36-154-36U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-38-154-34U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-38-154-38U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-42-204-38U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-46-164-46U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-46-209-42U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-32-164-32U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-42-204-42U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-44-114-44U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-44-209-44U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-44-259-44U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-32-209-32U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-34-209-30U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-34-209-34U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-36-154-32U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-36-259-36U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-38-199-38U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-40-154-40U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-42-114-42U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-42-159-42U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-42-259-42U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-44-164-44U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-32-104-32U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-32-164-28U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-36-199-32U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-36-199-36U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-38-199-34U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-40-259-40U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-42-159-38U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-44-164-40U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-32-259-32U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-34-109-34U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-36-109-36U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-38-259-38U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-46-114-46U
Affected products: Relay®Pro Thoracic Stent-Graft System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 28-N4-46-209-46U
The hazard
Through post-market surveillance, Bolton Medical received complaints where 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. Bolton Medical received 4 complaints associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)