Bard recalls GlidePath Long-Term Hemodialysis Catheters with preloaded stylet (REF 5397350) due to tunneler tip breaking during placement, risking complications. Affected units have specific model and expiration dates.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Bard is recalling GlidePath hemodialysis catheters with a preloaded stylet (model 5397350) because the tunneler tip can break during catheter placement. This could lead to complications for patients needing dialysis treatment.
The tunneler tip can break during catheter placement, potentially causing complications like infection or improper catheter function. This is a risk during the procedure but not during normal use.
Patients using hemodialysis treatment with this specific catheter model are most at risk. Healthcare providers who place the catheter may also be affected.
Check for the model number 5397350 on the catheter packaging or label. The catheter has a length of 35cm and is marked with expiration date 3/31/2020.
Look for the model number 5397350 on the catheter or its packaging.
If you have this catheter, contact your healthcare provider for guidance on next steps.
The recall is due to a risk of tunneler tip breaking during placement, which could cause complications. It is not safe to use without checking the recall status.
Check the model number on the catheter. If it matches the recalled model, contact your healthcare provider for guidance.
The catheter has an expiration date of 3/31/2020, but the exact manufacturing date is not specified in the recall notice.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2394-2019 — Bard Bard Hello, I own a Bard that is covered by recall Z-2394-2019 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.
