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.
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Cordis is recalling POWERFLEX PRO PTA Dilatation Catheters that may burst during use, risking serious injury. This recall affects specific model numbers and lot dates sold between 2020-04-30 and 2020-11-30.
The catheter's shaft subassembly may fail under pressure during dilation procedures, potentially causing injury or death. This failure occurs if the device does not meet internal burst strength specifications.
Patients undergoing vascular procedures with the POWERFLEX PRO catheter are most at risk. The recall applies to specific model numbers and lot dates sold between April 2020 and November 2020.
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.
If you have the recalled catheter, stop using it right away to prevent potential burst failure.
The catheter's shaft subassembly may fail under pressure during dilation procedures, potentially causing injury or death.
Affected models include catalog numbers 4400322X, 4400602S, 4400515X, 4400308S, and 4400508S with specific lot numbers sold between April 2020 and November 2020.
The recall record does not specify a return process, but you should stop using it immediately.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0390-2019 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0390-2019 from Cordis. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
