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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device stabilizer, heart
Regulation Description Cardiovascular surgical instruments.
Product CodeMWS
Regulation Number 870.4500
Device Class 1

Device Problems
Break 64
Mechanical Problem 33
Detachment Of Device Component 8
Suction Problem 6
Use of Device Problem 4
Material Too Rigid or Stiff 3
Insufficient Information 3
Unstable 3
Detachment of Device or device Component 2
Decrease in Suction 2
Component Missing 2
Pressure Problem 2
Knob 2
Unintended System Motion 2
Inadequacy of Device Shape and/or Size 2
Packaging Problem 2
Inadequate Service 1
Device Operates Differently Than Expected 1
Positioning Problem 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Environmental Particulates 1
Device Packaging Compromised 1
Fracture 1
Improper or Incorrect Procedure or Method 1
Contamination / decontamination Problem 1
Connection Problem 1
Mechanics Altered 1
Adverse Event Without Identified Device or Use Problem 1
Material Frayed 1
Defective Component 1
Total Device Problems 154

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular, LLC II Oct-24-2014
2 Terumo Cardiovascular Systems Corporation II Feb-22-2017
3 Terumo Cardiovascular Systems Corporation II Feb-14-2017

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