PIDClass II

Esophageal Dilator Balloon With Or Without Electrode Sensors

Gastroenterology, Urology · 21 CFR 876.5980

To dilate the lower esophageal sphincter of patients with Achalasia.

MDR events143All time

Recalls1All time

Registered firms8Currently listed

510(k) clearances3All time

Recent MDR events

143 adverse event reports on file

Event type breakdown

Malfunction115

Injury27

Death1

Most-reported manufacturers

Covidien Ag Juarez (mmj)99 Boston Scientific Corporation38 Cook Endoscopy2 Crospon Ltd1 Gyrus Acmi, Inc1 Medtronic / Covidien Llc1 Wilson-cook Medical Inc (cook Endoscopy)1

Recalls

1 recall events for this product code

Covidien, LLC
Open, ClassifiedJun 7, 2024
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
Z-2038-2024 · View FDA record ↗

Registered firms

8 firms currently registered for this product code

510(k) clearances

3 clearances for this product code