Bard recalls GlidePath long-term hemodialysis catheters with preloaded stylet (model 5397190) due to molded tip breaking during placement, risking complications. Affected units have specific lot numbers 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 long-term hemodialysis catheters with preloaded stylet (model 5397190) because the molded tip can break during catheter placement. This breakage may cause complications for patients needing dialysis treatment.
The molded tip of the tunneler can break during catheter placement, potentially causing complications like infection or improper positioning. This breakage occurs during the procedure when the catheter is being inserted into the patient's body.
Patients using hemodialysis treatments with this specific catheter model are most at risk. Healthcare providers who place the catheter may also be affected.
Check for the model number 5397190 on the catheter label. Affected units have specific lot numbers and expiration dates listed in the recall notice.
Look for the model number 5397190 on the catheter label to confirm if it is affected.
The molded tip of the tunneler can break during catheter placement, potentially causing complications for patients needing dialysis.
Check the catheter label for the model number 5397190. If affected, contact Bard for further instructions.
Yes, affected units have specific lot numbers and expiration dates listed 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-2390-2019 — Bard Bard Hello, I own a Bard that is covered by recall Z-2390-2019 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.