Abbott Vascular recalls NC TREK Coronary Dilatation Catheters (REF 1012453-12) due to potential balloon deflation issues. Affected units include specific lot numbers and sizes.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott Vascular is recalling certain NC TREK Coronary Dilatation Catheters because they may have trouble deflating the balloon. This could lead to improper treatment during medical procedures if the catheter fails to deflate correctly.
The catheter's balloon may not deflate properly during use, which could cause the catheter to become stuck in the artery. This might lead to complications like blockages or damage to the blood vessel during coronary procedures.
Healthcare professionals using these catheters for coronary procedures are most at risk. Patients receiving the catheter during medical treatment may be affected if the device fails.
Check for the product name 'NC TREK Coronary Dilatation Catheter', reference number 1012453-12, and lot numbers 90730G1 through 91101G1. The catheter is sold under the brand name Abbott Vascular.
Identify the product name, reference number, and lot numbers to confirm if your catheter is affected.
The recall indicates a potential issue with balloon deflation, so affected units should not be used until the remedy is applied.
Contact Abbott Vascular directly to confirm if your specific lot number is affected and follow their instructions.
The recall states that the catheter may have difficulty deflating the balloon, which could lead to complications during medical procedures.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1129-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1129-2020 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.
