FDA issues safety alert on BD’s Rotarex catheters

USA – The FDA has raised concerns about BD’s Rotarex atherectomy system, a medical device used to clear blocked arteries.

The agency reported that 30 serious injuries and four deaths have been linked to fractures or breaks in the device.

These issues occur within the catheter’s spinning tip and helix-shaped rotor, which help break down and remove calcified blockages from blood vessels.

BD’s response and FDA’s early warning

On February 5, BD issued a medical device correction notice to healthcare providers, advising them to review updated instructions and online training.

However, no products need to be returned at this time. The FDA has not officially classified this as a recall but included it in its early alert pilot program, which was introduced to quickly share safety concerns with the public.

The FDA approved BD’s updated Rotarex instructions on January 30. A few days later, BD notified customers about the new guidelines and provided additional training resources.

Previously, the FDA shared safety updates months after companies informed their customers, but the new pilot program allows for faster public alerts on potentially high-risk devices.

Causes of fractures and risk factors

BD has identified specific anatomical and procedural factors that could contribute to catheter fractures.

The company advised against using Rotarex if the catheter needs to bend at an angle sharper than 4 centimeters in diameter, such as where the descending aorta splits into the arteries leading to the legs. Other risk factors include:

• Severe calcification in the blood vessels
• Sharp or excessive bending of the catheter during use
• Inadequate blood flow, which may lead to overheating and stress on the device
• Lack of a kink-resistant, reinforced sheath, which helps stabilize the catheter

To reduce risks, BD recommends using a properly reinforced sheath, ensuring continuous blood flow, and maintaining smooth, steady movements when operating the device.

Reported cases and ongoing investigation

Along with the serious injuries and deaths, BD has documented 115 cases where additional intervention was needed due to helix rotor fractures.

In some cases, broken device fragments had to be surgically removed, which could lead to vessel damage and severe bleeding.

Both BD and the FDA are continuing their investigations and will provide updates as they gather more information.

BD’s interventional business unit, which includes Rotarex, is a key focus for the company following the separation of its life sciences division. The company aims to increase market penetration of Rotarex as part of its growth strategy.