EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Reported: June 19, 2024 Initiated: April 25, 2024 #Z-2038-2024
Product Description
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
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.
Details
- Recalling Firm
- Covidien, LLC
- Units Affected
- N/A
- 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.
- Location
- Santa Clara, CA
Frequently Asked Questions
What product was recalled? ▼
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only. Recalled by Covidien, LLC. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 19, 2024. Severity: Moderate. Recall number: Z-2038-2024.
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