ev3 Inc recalls Pacific Xtreme PTCA Balloon Dilation Catheters with labeling discrepancies for Rated Burst Pressure (RBP) values. Affected models and lots listed. No remedy specified in official notice.
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
ev3 Inc is recalling specific models of Pacific Xtreme PTCA Balloon Dilation Catheters due to a labeling error in the Rated Burst Pressure (RBP) value. This could lead to incorrect pressure measurements during medical procedures, potentially causing complications if used improperly.
The labeling discrepancy means the Rated Burst Pressure (RBP) value may be incorrect, which could lead to improper pressure measurements during medical procedures. If the actual pressure exceeds the labeled RBP, it might cause device failure or complications during treatment.
Medical professionals using the Pacific Xtreme catheters for percutaneous transluminal coronary angioplasty (PTCA) procedures are likely affected. Patients undergoing these procedures with the recalled models are at risk if the labeling error impacts device safety.
Check the model number and lot numbers listed in the recall notice. The affected models include PCU060150090, PCU060150130, PCU060200090, PCU060200130, PCU060250090, PCU060250130, PCU060300090, and PCU060300130 with specific lot numbers from March 2022 to April 2023.
Identify the model number and lot numbers on your Pacific Xtreme PTCA Balloon Dilation Catheter to see if it matches the affected list provided in the recall.
The recall is due to a labeling discrepancy for the Rated Burst Pressure (RBP) value, which could lead to incorrect pressure measurements during medical procedures.
The official recall notice does not specify a remedy, so you should check the product details against the list of affected models and lot numbers provided in the recall.
The labeling error could lead to improper pressure measurements during procedures, potentially causing device failure or complications if the actual pressure exceeds the labeled RBP value.
We’ve drafted a message you can send ev3 Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-3055-2020 — ev3 Inc ev3 Inc Hello, I own a ev3 Inc that is covered by recall Z-3055-2020 from ev3 Inc. 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.
