Recall Z-2038-2024 ยท PID Esophageal Dilator Balloon With Or Without Electrode Sensors
Covidien, LLC
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
| Date | Jun 7, 2024 (initiated Apr 25, 2024) |
| Status | Open, Classified |
| Reason | Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms. |
| Root cause | Nonconforming Material/Component |
| Action | On April 25, 2024, Medtronic issued a "Urgent: Medical Device Recall" Notification. Medtronic ask consignees to take the following actions: 1. Immediately identify and quarantine all unused EsoflipTM dilation catheter 30mm Model # ES-330 from the affected lot numbers. 2. Return all unused affected product(s) in your inventory to: Medtronic Attn: Field Returns Dept. 195 McDermott Road North Haven, CT 06473 USA 3. Credit for returned catheters that are part of this recall will be applied upon receipt. 4. Please complete and return the enclosed Customer Confirmation Form, even if you have |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Canada, Denmark, Germa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132337 | ESOFLIP BALLOON DILATION CATHETER Crospon, Ltd., Oct 7, 2013 |