Abbott Vascular recalls NC TREK Coronary Dilatation Catheters (REF 1012455-12) due to potential balloon deflation issues. Affected units may cause complications during medical procedures.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters (REF 1012455-12) because they may have trouble deflating the balloon during medical procedures. This could lead to complications if used improperly.
The catheter's balloon may not deflate properly during medical procedures, potentially causing complications like vessel damage or incomplete treatment. This risk occurs when the balloon is inflated and needs to be deflated for the procedure to continue safely.
Healthcare professionals using the catheter for coronary procedures are most at risk. Patients receiving these procedures may also be affected if the catheter malfunctions.
Check for the product name 'NC TREK Coronary Dilatation Catheter' with reference number 1012455-12. The device was sold with lot numbers 90918G1, 90930G1, 90926G1, and 91031G1.
Verify the product name and reference number on the device packaging to confirm if it matches the recalled items.
The catheter may have difficulty or inability to deflate the balloon during medical procedures, which could lead to complications.
Healthcare professionals should check the product details to confirm if they have the recalled catheter and contact Abbott Vascular for further instructions.
Yes, the affected lot numbers are 90918G1, 90930G1, 90926G1, and 91031G1.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1137-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1137-2020 from Abbott Vascular. 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.
