Boston Scientific recalled 156 units of the Extractor Pro RX Retrieval Balloon Catheter on August 28, 2025. The product is mislabelled, indicating the wrong position of the skive hole. This recall affects distribution across 15 states in the U.S.
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
The recalled products include UPN (REF): M00547030 (9-12mm Below) and M00547000 (9-12mm Above). They were distributed nationwide across California, Colorado, Georgia, Idaho, Illinois, Indiana, Massachusetts, Maine, Michigan, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, and Washington.
The hazard arises from incorrect labeling of the catheter. The skive hole is inaccurately marked as being above the balloon when it is actually below.
As of now, there are no reported injuries or incidents associated with this recall. However, the potential for misuse due to labeling errors poses a significant risk.
Patients and healthcare providers must stop using the device immediately. Follow the recall instructions provided by Boston Scientific Corporation and contact healthcare providers for further guidance.
For more information, contact Boston Scientific Corporation. Visit the FDA's recall page for additional details.
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