• 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 syringe, balloon inflation
Regulation Description Angiographic injector and syringe.
Product CodeMAV
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 101 101
2021 186 186
2022 437 437
2023 220 220
2024 420 420
2025 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 974 974
Loose or Intermittent Connection 202 202
Display or Visual Feedback Problem 144 144
Break 82 82
Physical Resistance/Sticking 45 45
Incorrect, Inadequate or Imprecise Result or Readings 44 44
Device Contamination with Chemical or Other Material 41 41
Inflation Problem 23 23
Material Separation 16 16
Unsealed Device Packaging 15 15
Improper or Incorrect Procedure or Method 12 12
Tear, Rip or Hole in Device Packaging 11 11
Deflation Problem 9 9
Packaging Problem 9 9
Appropriate Term/Code Not Available 8 8
Material Integrity Problem 8 8
Defective Device 6 6
Shipping Damage or Problem 6 6
Noise, Audible 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Contamination 5 5
Product Quality Problem 5 5
Mechanical Problem 5 5
Device Contaminated During Manufacture or Shipping 4 4
Crack 4 4
Detachment of Device or Device Component 4 4
Unstable 3 3
Failure to Zero 3 3
Obstruction of Flow 3 3
Mechanical Jam 2 2
Pressure Problem 2 2
Insufficient Information 2 2
Difficult to Remove 2 2
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Device Sensing Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Output Problem 1 1
Fracture 1 1
Fluid/Blood Leak 1 1
Material Split, Cut or Torn 1 1
Material Rupture 1 1
Retraction Problem 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Device Damaged Prior to Use 1 1
Low Readings 1 1
Moisture Damage 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1257 1257
No Consequences Or Impact To Patient 90 90
Insufficient Information 14 14
Air Embolism 6 6
No Patient Involvement 6 6
No Known Impact Or Consequence To Patient 5 5
Laceration(s) 3 3
Arrhythmia 3 3
Cardiac Arrest 3 3
Low Blood Pressure/ Hypotension 3 3
Vascular Dissection 3 3
Hemorrhage/Bleeding 2 2
Perforation 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Bradycardia 1 1
Thrombosis/Thrombus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Apr-13-2022
2 Abbott Vascular Inc II Dec-20-2024
-
-