U.S. Food and Drug Administration04.07.20
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
The Boston Scientific IMAGER II 5F Angiographic Catheters are used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries.
Boston Scientific is recalling IMAGER II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation.
Use of the affected product may lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital. There is also the potential for serious adverse events including obstruction of blood flow (embolism), stroke, or death.
There are nine reported injuries.
Healthcare providers using and patients receiving cardiac surgery with the Boston Scientific IMAGER II 5F Angiographic Catheters may be affected.
On February 11, 2020, Boston Scientific Corporation sent a letter to customers informing them of the affected lot numbers and provided the following instructions:
Recalled Product
- Boston Scientific Corporation IMAGER II 5F Angiographic Catheters
- See lot numbers below under Full List of Affected Devices
- Distribution Dates: July 16, 2018 to November 26, 2019
- Devices Recalled in the U.S.: 6,130
- Date Initiated by Firm: February 11, 2020
The Boston Scientific IMAGER II 5F Angiographic Catheters are used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries.
Boston Scientific is recalling IMAGER II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation.
Use of the affected product may lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital. There is also the potential for serious adverse events including obstruction of blood flow (embolism), stroke, or death.
There are nine reported injuries.
Healthcare providers using and patients receiving cardiac surgery with the Boston Scientific IMAGER II 5F Angiographic Catheters may be affected.
On February 11, 2020, Boston Scientific Corporation sent a letter to customers informing them of the affected lot numbers and provided the following instructions:
- Remove any affected lots in the hospital inventory
- Stop using any product with the affected lot number
- Complete the Verification Form and include the quantity of units from each affected lot
- Return the affected lots to Boston Scientific Corporation