Summary
The FDA issued a Class II for EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only by Covidien, LLC. Reason: Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead.
Details
Source
Device Recall
External ID
Z-2038-2024
Action Date
2024-06-19
Status
Ongoing
Category
device
Product Description
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
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
Quantity Affected: N/A
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-25
Company
Santa Clara, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LLC have FDA actions?
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2038-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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