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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stabilizer, heart
Product CodeMWS
Regulation Number 870.4500
Device Class 1

MDR Year MDR Reports MDR Events
2019 57 57
2020 43 43
2021 74 74
2022 98 98
2023 67 67
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 93 93
Positioning Failure 60 60
Break 59 59
Positioning Problem 23 23
Suction Problem 18 18
Detachment of Device or Device Component 14 14
Suction Failure 13 13
Component Missing 11 11
Material Deformation 10 10
Physical Resistance/Sticking 10 10
Insufficient Information 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Packaging Problem 6 6
Use of Device Problem 6 6
Defective Component 6 6
Device Damaged Prior to Use 5 5
Defective Device 5 5
Material Separation 5 5
Fracture 3 3
Material Too Soft/Flexible 3 3
Illegible Information 2 2
Crack 2 2
Device Slipped 2 2
Unstable 2 2
Incomplete or Missing Packaging 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 1 1
Environmental Particulates 1 1
Mechanical Jam 1 1
Mechanics Altered 1 1
Contamination /Decontamination Problem 1 1
Shipping Damage or Problem 1 1
Unintended System Motion 1 1
Device Difficult to Setup or Prepare 1 1
Device Difficult to Program or Calibrate 1 1
Material Too Rigid or Stiff 1 1
Loss of or Failure to Bond 1 1
Collapse 1 1
Contamination 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Misassembled During Installation 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 231 231
No Consequences Or Impact To Patient 74 74
Insufficient Information 24 24
No Known Impact Or Consequence To Patient 22 22
No Patient Involvement 9 9
No Information 3 3
Hematoma 3 3
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Bradycardia 2 2
Tissue Damage 2 2
Ventricular Fibrillation 1 1
Stroke/CVA 1 1
Death 1 1
Ischemia 1 1
Myocardial Infarction 1 1
Perforation 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Injury 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular, LLC II Dec-19-2023
2 Maquet Cardiovascular, LLC II Oct-22-2023
3 Terumo Cardiovascular Systems Corporation II Apr-06-2021
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