Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device esophageal dilator balloon with or without electrode sensors
Regulation Description Gastrointestinal tube and accessories.
Definition To dilate the lower esophageal sphincter of patients with Achalasia.
Product CodePID
Regulation Number 876.5980
Device Class 2

MDR Year MDR Reports MDR Events
2020 4 4
2021 10 10
2022 9 9
2023 10 10
2024 83 83
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Device Difficult to Program or Calibrate 52 52
Adverse Event Without Identified Device or Use Problem 21 21
Burst Container or Vessel 17 17
Insufficient Information 14 14
Inadequacy of Device Shape and/or Size 9 9
Application Program Problem 4 4
Device Damaged Prior to Use 3 3
Inflation Problem 3 3
Device Difficult to Setup or Prepare 3 3
Pressure Problem 2 2
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Break 1 1
Failure to Conduct 1 1
Crack 1 1
Difficult to Advance 1 1
Gradient Increase 1 1
Leak/Splash 1 1
Nonstandard Device 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1
Output below Specifications 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 98 98
Perforation of Esophagus 11 11
Perforation 9 9
Insufficient Information 5 5
Chest Pain 4 4
No Consequences Or Impact To Patient 3 3
Hemorrhage/Bleeding 2 2
Unintended Radiation Exposure 2 2
Pyrosis/Heartburn 1 1
Hypersensitivity/Allergic reaction 1 1
No Code Available 1 1
Syncope/Fainting 1 1
Asystole 1 1
Respiratory Insufficiency 1 1
Pneumothorax 1 1
Sepsis 1 1
Laceration(s) of Esophagus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LLC II Jun-07-2024
-
-