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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, balloon, intra-aortic and control
Regulation Description Intra-aortic balloon and control system.
Product CodeDSP
Regulation Number 870.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Gas Leak 387
Device Alarm System 367
Fluid Leak 329
Device Contamination with Chemical or Other Material 224
Leak / Splash 218
Material Rupture 202
Failure to Sense 164
Inflation Problem 136
Pumping Stopped 128
Unexpected Shutdown 117
Inability to Auto-Fill 109
Appropriate Term/Code Not Available 102
Difficult to Advance 99
Difficult to Insert 98
Premature Discharge of Battery 97
Battery Problem 95
Break 94
No Display / Image 92
Communication or Transmission Problem 78
Pressure Problem 76
Connection Problem 73
Optical Problem 73
Failure to Power Up 70
Display or Visual Feedback Problem 70
Erratic or Intermittent Display 58
Device Displays Incorrect Message 58
Incorrect, Inadequate or Imprecise Result or Readings 54
Charging Problem 53
Failure to Zero 50
Difficult to Remove 46
Electrical /Electronic Property Problem 45
Balloon 38
Power Problem 37
Device Contamination with Body Fluid 37
Material Deformation 36
Calibration Problem 35
Noise, Audible 34
Adverse Event Without Identified Device or Use Problem 33
Unable to Obtain Readings 31
Output below Specifications 31
Occlusion Within Device 31
Deformation Due to Compressive Stress 30
Kinked 29
Obstruction of Flow 25
Loose or Intermittent Connection 25
Filling Problem 25
Difficult to Flush 22
Incomplete or Inadequate Connection 22
No Device Output 21
Low Battery 21
Device Markings / Labelling Problem 20
Crack 19
Moisture or Humidity Problem 19
Audible Prompt / Feedback 18
Entrapment of Device 18
Complete Blockage 17
Failure to Calibrate 16
Application Program Freezes, Becomes Nonfunctional 16
Mechanical Problem 16
Material Puncture / Hole 16
Failure to Charge 15
Output Problem 15
Device Operates Differently Than Expected 14
Migration or Expulsion of Device 14
No Audible Alarm 13
Circuit Failure 13
Increase in Pressure 13
Overheating of Device 11
Detachment of Device or device Component 11
Defective Component 11
Device Damaged Prior to Use 10
Retraction Problem 10
Intermittent Communication Failure 10
Detachment Of Device Component 10
Failure to Read Input Signal 10
Failure to Pump 9
Failure to Advance 9
Pumping Problem 9
No Apparent Adverse Event 8
Component Missing 8
Failure to Unfold or Unwrap 8
Device Sensing Problem 8
Volume Accuracy Problem 7
Aspiration Issue 7
Failure to Run on Battery 7
Material Separation 7
Fitting Problem 7
Battery Problem: Low Impedance 7
Physical Resistance 7
Partial Blockage 6
Insufficient Information 6
Unraveled Material 6
Material Twisted / Bent 6
Temperature Problem 6
Restricted Flow rate 6
Inaccurate Synchronization 6
Backflow 6
Device Emits Odor 5
Off-Label Use 5
Difficult to Interrogate 5
Total Device Problems 4951

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Mar-10-2015
2 Arrow International Inc II Mar-02-2015
3 Arrow International, Inc., Division of Teleflex Medical Inc. I Mar-11-2016
4 Datascope Corp. I Jul-16-2019
5 Datascope Corporation II Jul-12-2019
6 Datascope Corporation II Oct-11-2018
7 Datascope Corporation II Apr-16-2018
8 Datascope Corporation II Jun-08-2016
9 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
10 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
11 Maquet Datascope Corp - Cardiac Assist Division I Sep-05-2017
12 Maquet Datascope Corp - Cardiac Assist Division I Jun-23-2017
13 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
14 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
15 Maquet Datascope Corp - Cardiac Assist Division II Feb-23-2015
16 Maquet Datascope Corp - Cardiac Assist Division II Feb-07-2015

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