Abbott recalls NC Traveler Coronary Dilatation Catheters (REF 1013157-12) due to potential balloon deflation failure. This device is not cleared for U.S. distribution and may cause complications during procedures.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott is recalling NC Traveler Coronary Dilatation Catheters (REF 1013157-12) 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 correctly during medical procedures, potentially causing complications like vessel damage or procedure failure. This device is not approved for sale in the U.S. and is intended for specific medical use only.
Healthcare professionals using the device for coronary procedures are affected. Patients receiving this catheter during procedures may be at risk if the balloon fails to deflate properly.
Check for the product name 'NC Traveler Coronary Dilatation Catheter' with reference number 1013157-12. The device is not cleared for U.S. distribution and was sold with lot numbers starting with 90812G1.
Verify if your catheter has the reference number 1013157-12 and lot numbers starting with 90812G1.
The device is not cleared for U.S. distribution and may have balloon deflation issues, so it should not be used in medical procedures.
Look for the reference number 1013157-12 and lot numbers starting with 90812G1 on the catheter.
The official recall does not specify a remedy, so contact Abbott Vascular for guidance.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1141-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1141-2020 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.
