Stop using nowMedical device recall · FDA · Published September 5, 2018
Cordis POWERFLEX PRO Catheter Recall: Risk of Burst Shaft Failure
Cordis recalls POWERFLEX PRO PTA Dilatation Catheters due to potential burst shaft failure during use. Affected units have specific catalog and lot numbers. Stop using immediately if you own one.
“Cordis POWERFLEX PRO Catheter Recall: Risk of Burst Shaft Failure.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69907-cordis-powerflex-pro-catheter-recall-risk-of-burst-shaft-failure. Based on FDA recall #Z-0390-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0390-2019%22&limit=1).
The FDA announced on 2018-09-05 that Cordis Corporation is recalling Cordis POWERFLEX PRO PTA Dilatation Catheters because the shaft may not meet burst strength specifications. The recall affects 162 units distributed worldwide, including 74 in the United States.
How to tell if you have it
Brand: Cordis
Product: Cordis POWERFLEX PRO PTA Dilatation Catheter
Catalog Number 4400322X, Lot Number 82144115, Expiry Date 2020-04-30
Catalog Number 4400602S, Lot Number 82144141, Expiry Date 2020-05-31
Catalog Number 4400515X, Lot Number 82144947, Expiry Date 2020-06-30
Catalog Number 4400308S, Lot Number 82148810, Expiry Date 2020-11-30
Catalog Number 4400508S, Lot Number 82148811, Expiry Date 2020-11-30
The hazard
The product may not meet the internal manufacturing shaft subassembly burst strength specification, according to the FDA. This failure of the burst shaft test is the identified hazard.
Context
GovInfoNow's records show Cordis Corporation has 9 other recalls on record since 2017-11-15. Other recent recalls include the Cordis SMART Flex Biliary Stent System Recall (2021-10-01), the Cordis SUPER TORQUE MB 5F PIG Angiographic Catheter Recall (2021-07-21), and the Cordis SABER PTA Catheter Recall (2021-07-19). Other recent recalls of similar products include Bard PowerPICC Catheters Recall (2026-05-21), Penumbra RED 62 Reperfusion Catheter Recall (2026-07-24), and Bard PowerMidline Catheter Recall (2026-05-21).
How to tell if you have this one
Check for catalog numbers 4400322X, 4400602S, 4400515X, 4400308S, or 4400508S on the device packaging. The recall covers units sold with specific lot numbers between April 2020 and November 2020.
Brand
Cordis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
If you have the recalled catheter, stop using it right away to prevent potential burst failure.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 22 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Mississippi, Missouri, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Wisconsin.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0390-2019 (September 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0390-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.