Class 2 Device Recall BALLOON DILATION CATHETER

• Date Initiated by Firm: April 25, 2024
• Date Posted: June 07, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2038-2024
• Recall Event ID: 94541
• 510(K)Number: K132337
• Product Classification: esophageal dilator balloon with or without electrode sensors - Product Code PID
• Product: EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
• Code Information: GTIN Number: 10884521809451/ Lot: 22K0854JZ, 23H0552JZ; GTIN Number: 20884521809458/ Lot: 22E0781JZ, 22E0997JZ, 22I0422JZ, 22I0424JZ, 22I0425JZ, 22J1362JZ,22K0743JZ, 22K0744JZ, 22K0745JZ,22K0746JZ, 22K0854JZ, 23A0109JZ,23A0111JZ, 23A1200JZ, 23A1201JZ,23A1202JZ, 23C0144JZ, 23C0668JZ, 23C0669JZ, 23D0777JZ, 23D0778JZ,23H0047JZ, 23H0552JZ, 23H0553JZ,23H0554JZ, 23H0623JZ, 23H0624JZ,23L0331JZ, 23L0338JZ, 23L0339JZ,24A0014JZ, 24A0015JZ, 24B0392JZ
• FEI Number: 3004904811
• Recalling Firm/ Manufacturer: Covidien, LLC; 3062 Bunker Hill Ln; Santa Clara CA 95054-1105
• For Additional Information Contact: Oded Cojocaru; 770-662-0870
• Manufacturer Reason for Recall: Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
• FDA Determined 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 no product to return. 5. Product purchased directly from Medtronic, please contact 1-800-448-3644 (option 2 followed by option 2 again) for Return Goods Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. 6. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 7. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 8. Please transfer this notice to other organizations on which this action has an impact. 9. Please maintain a copy of this notice in your records.
• 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, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PID