Bard recalls POWERPORT ClearVUE Slim implants with incorrect port flushing instructions that could lead to improper use. Affected units have specific identifiers; contact Bard for details.
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Bard is recalling POWERPORT ClearVUE Slim implants because the included Patient ID Card has wrong flushing instructions. This could cause improper use if patients follow incorrect steps.
The Patient ID Card contains incorrect port flushing instructions. If patients follow these wrong steps, it could lead to improper use of the implant. However, the hazard does not involve immediate physical harm like injury or death.
Patients with Bard POWERPORT ClearVUE Slim implants who received the recalled model with incorrect flushing instructions. Those using the device for medical purposes are most at risk.
Check for the model name POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes. The product has specific UDI codes listed in the recall notice.
Verify the flushing instructions on the Patient ID Card match the correct procedure for the device.
No, the recall does not require stopping use. The hazard is about incorrect instructions, not immediate danger.
Check for the model name POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes and the specific UDI codes listed in the recall notice.
Contact Bard directly for guidance on verifying the instructions and ensuring proper use.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-1769-2018 — Bard Bard Hello, I own a Bard that is covered by recall Z-1769-2018 from Bard. 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.