Cook recalls Advance 35LP Low-Profile PTA Balloon Dilatation Catheters with incorrect balloon size labels. Product labeled as 6mm x 2cm may have a 4mm x 4cm balloon, causing potential misuse during medical procedures.
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Cook is recalling certain Advance 35LP Low-Profile PTA Balloon Dilatation Catheters due to incorrect labeling of balloon sizes. This could lead to improper use during medical procedures if the wrong balloon size is used.
The product is labeled with the wrong balloon dimensions (e.g., a 6mm x 2cm label may be on a 4mm x 4cm balloon). This mismatch could lead to improper use during medical procedures if the wrong balloon size is used.
Healthcare professionals using the catheters for percutaneous transluminal angioplasty procedures are most at risk. Patients receiving these procedures may be affected if the incorrect balloon size is used.
Check for catalog numbers PTA5-35-135-6-2 .0 or PTA5-35-135-4-4 .0. The product was sold with UDI numbers 10827002522647 and 10827002522524.
Verify the balloon size label on the catheter to ensure it matches the catalog number.
Cook is recalling these catheters because they have incorrect labeling of balloon sizes, which could lead to improper use during medical procedures.
The record does not specify the correct balloon size; it only states that the labels are swapped between 6mm x 2cm and 4mm x 4cm.
Check for catalog numbers PTA5-35-135-6-2 .0 or PTA5-35-135-4-4 .0 with UDI numbers 10827002522647 or 10827002522524.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1521-2018 — Cook Cook Hello, I own a Cook that is covered by recall Z-1521-2018 from Cook. 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.
