Abbott Vascular recalls NC TREK Coronary Dilatation Catheters (REF 1012453-08) due to potential balloon deflation issues. Affected units include specific lot numbers sold for medical use only.
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 during medical procedures. This could lead to complications if the catheter is used incorrectly.
The catheter's balloon may not deflate properly during use, which could cause blockages or damage to blood vessels. This risk is specific to medical procedures where the catheter is inflated and deflated repeatedly.
Healthcare professionals using the catheter for coronary procedures are most at risk. Patients receiving the catheter for medical treatment may also be affected if the device malfunctions.
Check for the product name 'NC TREK Coronary Dilatation Catheter' with reference number 1012453-08. Affected units have specific lot numbers: 90731G1, 90921G1, 90808G1, 90928G1, 90826G1, 91003G1, 90906G1, 91017G1, 91106G1.
Identify the lot number on the catheter packaging to determine if it is affected.
Reach out to Abbott Vascular for guidance on next steps if the catheter is confirmed affected.
The recall indicates a potential issue with balloon deflation, so affected units should not be used until further instructions are received.
Affected lot numbers include 90731G1, 90921G1, 90808G1, 90928G1, 90826G1, 91003G1, 90906G1, 91017G1, and 91106G1.
Only if it is not in the affected lot numbers and the manufacturer has not issued specific instructions for your use case.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1128-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1128-2020 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.
