Abbott Vascular recalls NC Traveler Coronary Dilatation Catheters (REF 1013158-08) due to potential balloon deflation failure. This may cause complications during procedures. Affected units were sold with specific lot numbers.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters (REF 1013158-08) 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 medical procedures, potentially causing complications like blockages or tissue damage. This issue occurs due to a design flaw in the balloon mechanism.
Healthcare professionals using the catheter for coronary procedures are most at risk. Patients receiving these procedures may also be affected if the catheter is used improperly.
Check for the part number 1013158-08 on the catheter packaging or label. Affected units were sold with lot numbers starting with 90812G1. The catheter is only for prescription use in the U.S.
Look for the part number 1013158-08 and lot numbers starting with 90812G1 on the catheter packaging or label.
The recall indicates potential balloon deflation issues, so it is not recommended for use until the remedy is applied. However, the remedy is not specified in the record.
Check the part number and lot numbers on the catheter packaging or label. If it matches the recalled items, contact Abbott Vascular for further instructions.
No, the catheter is not cleared for commercial distribution in the United States.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1143-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1143-2020 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.
