ev3 Pacific Xtreme Balloon Catheter Recall: Labeling Error in Burst Pressure
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.
Recall notice
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/64424-ev3-pacific-xtreme-balloon-catheter-recall-labeling-error-in-burst.
Source Summary by GovInfoNow · govinfonow.com/recall/64424-ev3-pacific-xtreme-balloon-catheter-recall-labeling-error-in-burst · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3055-2020
Cite this page
“ev3 Pacific Xtreme Balloon Catheter Recall: Labeling Error in Burst Pressure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64424-ev3-pacific-xtreme-balloon-catheter-recall-labeling-error-in-burst. Based on FDA recall #Z-3055-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3055-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
ev3 Inc- Category
Medical device
What to do — step by step
Check Product Details
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.
Where it went and when
Where it was distributed
Distributed in 40 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-3055-2020 (August 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3055-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.