Abbott Vascular recalls NC TREK Coronary Dilatation Catheters that may have difficulty deflating the balloon, which could cause injury during procedures. Affected units include specific model and lot numbers.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters that may not deflate properly. This could lead to complications during medical procedures if the catheter is used without the balloon fully deflating.
The catheter's balloon may not deflate correctly during use, which could cause injury to the patient's blood vessels or tissues. This issue occurs during procedures where the catheter is used to open blocked coronary arteries.
Healthcare professionals using the NC TREK Coronary Dilatation Catheter for procedures are most at risk. Patients receiving these catheters during medical treatments may also be affected.
Check for the model number 1012455-20 on the catheter packaging or label. The affected units were sold with lot numbers 91010G1 and 91026G1.
Look for the model number 1012455-20 and lot numbers 91010G1 or 91026G1 on the catheter packaging.
The catheter may have difficulty or inability to deflate the balloon, which could cause injury during medical procedures.
The official recall notice does not specify a remedy or action for affected units.
Yes, lot numbers 91010G1 and 91026G1 are affected.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1139-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1139-2020 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.
