Boston Scientific recalls Rebel Monorail PtCr Coronary Stent System with missing hydrophilic coating that could cause device malfunction during procedures. Affected units have specific catalog numbers and were sold through medical channels.
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Boston Scientific is recalling certain Rebel Monorail PtCr Coronary Stent Systems because they may have missed a critical hydrophilic coating step during manufacturing. This could lead to improper device function during medical procedures, potentially causing complications for patients.
The catheters may have missed the hydrophilic coating step during manufacturing, creating a lubricious surface that could cause improper device function during procedures. This might lead to complications if the stent system malfunctions during cardiac interventions.
Healthcare professionals using the Rebel Monorail Stent System for cardiac procedures are most at risk. The recall affects specific medical devices sold to hospitals and clinics.
Check for the catalog number H7493927324300 or the specific model Rebel MR 3.0mm x 24mm. These devices were sold with lot number 24077337 and use-by date 2019-07-17.
Verify the catalog number H7493927324300 or model Rebel MR 3.0mm x 24mm on the device packaging.
The stent system may have missed the hydrophilic coating step during manufacturing, which could cause improper device function during procedures.
The official recall notice does not specify a remedy or action for affected devices.
Check for the catalog number H7493927324300 or the model Rebel MR 3.0mm x 24mm on the device packaging.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0580-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0580-2020 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.
