Boston Scientific recalls Hurricane RX Biliary Balloon Dilatation Catheters with specific model numbers and batch dates due to risk of the black sheath detaching from the catheter shaft.
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Boston Scientific is recalling Hurricane RX Biliary Balloon Dilatation Catheters with specific model numbers and batch dates because the black sheath may detach from the catheter shaft. This could lead to the catheter becoming stuck or causing injury during medical procedures.
The RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. This could cause the catheter to become stuck or lead to injury during medical procedures.
Healthcare professionals using these catheters for biliary procedures are most at risk. Patients undergoing such procedures with the recalled devices may experience complications.
Check the product's catalog reference numbers (M00545890 to M00545960) and batch dates listed in the recall notice. The devices have specific expiration dates ranging from February 2022 to June 2022.
Identify the catalog reference number and batch date on the device packaging or label.
Reach out to Boston Scientific for assistance with the recall process.
The recall includes Hurricane RX Biliary Balloon Dilatation Catheters with catalog reference numbers M00545890 to M00545960.
The products have expiration dates ranging from February 2022 to June 2022.
Check the catalog reference number and batch date on the device packaging or label. The affected devices have specific model numbers and batch dates listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0286-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0286-2021 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
