—#207541

Product

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

FDA product code: PID — Esophageal Dilator Balloon With Or Without Electrode Sensors
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K132337
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Covidien, LLC
Address: 3062 Bunker Hill Ln, Santa Clara, California 95054-1105

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-04-25
Posted by FDA: 2024-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207541. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.