Z-2038-2024Class II

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

Name: Z-2038-2024 EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Creator: Covidien, LLC
Published: 2024-04-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-04-25 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LLC began a recall of EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only on 2024-04-25. FDA classified it as Class II and gives the reason as "Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2038-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-25
Posted: 2024-06-07
Recalling firm: Medtronic, Inc.
Product: EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Product code: PID Esophageal Dilator Balloon With Or Without Electrode Sensors
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2038-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2038-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-07

Product code PID

K132337Class IIEsoflip Balloon Dilation CatheterCrospon, Ltd. / cleared 2013-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)