Recall Z-0146-2023 ยท DXE Catheter, Embolectomy
Edwards Lifesciences, LLC
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
| Date | Oct 28, 2022 (initiated Oct 6, 2022) |
| Status | Open, Classified |
| Reason | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| Root cause | Packaging |
| Action | On 10/06/2022, Edwards Lifesciences sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx 2nd Day to customer informing them that certain lots of Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes are exhibiting latex deterioration in the balloon. It was determined that storage of these devices in the same room room as high energy ionizing radiation sources which can act as an ozone generator to the immediate environment, can accelerate latex deterioration and subsequent balloon failures. Advice on action to be taken by users: It is requested that they do not store F |
| Quantity | 715,620 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe Edwards Lifesciences, LLC, Jun 12, 2020 |