Abbott Vascular recalls NC Traveler Coronary Dilatation Catheters (REF 1013157-08) due to potential balloon deflation issues. This device is not cleared for U.S. distribution.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott Vascular is recalling NC Traveler Coronary Dilatation Catheters (REF 1013157-08) because they may have trouble deflating the balloon. This could lead to complications during medical procedures if the catheter is used improperly.
The catheter's balloon may not deflate properly during use, which could cause blockages or complications in the blood vessels. This risk is specific to medical procedures where the catheter is used to treat coronary issues.
Healthcare professionals using this catheter for medical procedures are affected. Patients receiving the catheter as part of their treatment may also be impacted.
Check for the product name 'NC Traveler Coronary Dilatation Catheter' with part number 1013157-08. The device is not cleared for U.S. distribution and was sold with lot numbers starting with 91010G1.
Verify the part number and lot number on the catheter to confirm if it is affected.
The recall states the device is not cleared for U.S. distribution, so it should not be used in the United States.
The recall does not specify a remedy, so contact Abbott Vascular directly for guidance.
The hazard description mentions potential balloon deflation issues, but no specific risk of serious injury is stated.
We’ve drafted a message you can send Abbott Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1140-2020 — Abbott Vascular Abbott Vascular Hello, I own a Abbott Vascular that is covered by recall Z-1140-2020 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.