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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.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 5
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Gas Leak 509
Leak/Splash 372
Device Alarm System 368
Fluid Leak 363
Failure to Sense 276
Device Contamination with Chemical or Other Material 259
Material Rupture 234
Inability to Auto-Fill 214
Appropriate Term/Code Not Available 209
Unexpected Shutdown 203
Inflation Problem 184
Battery Problem 164
Break 156
Pumping Stopped 155
Difficult to Insert 148
Premature Discharge of Battery 148
Display or Visual Feedback Problem 144
Pressure Problem 142
Optical Problem 134
Difficult to Advance 123
Communication or Transmission Problem 116
No Display/Image 111
Failure to Power Up 103
Incorrect, Inadequate or Imprecise Resultor Readings 99
Connection Problem 98
Erratic or Intermittent Display 88
Charging Problem 79
Failure to Zero 70
Power Problem 68
Electrical /Electronic Property Problem 68
Calibration Problem 67
Material Deformation 63
Device Displays Incorrect Message 61
Noise, Audible 59
Difficult to Remove 59
Adverse Event Without Identified Device or Use Problem 54
Output below Specifications 48
Device Contamination with Body Fluid 46
Filling Problem 41
Balloon 38
Unable to Obtain Readings 38
Occlusion Within Device 31
Deformation Due to Compressive Stress 31
Mechanical Problem 31
Failure to Charge 30
Kinked 29
Obstruction of Flow 28
Output Problem 28
Loose or Intermittent Connection 28
Incomplete or Inadequate Connection 26
No Device Output 24
Crack 24
Audible Prompt/Feedback Problem 24
Moisture or Humidity Problem 24
Difficult to Flush 23
Material Puncture/Hole 22
Failure to Pump 21
Low Battery 21
Failure to Calibrate 21
Device Markings/Labelling Problem 21
No Audible Alarm 21
Entrapment of Device 20
Restricted Flow rate 19
Application Program Freezes, Becomes Nonfunctional 19
Unraveled Material 18
Complete Blockage 18
Temperature Problem 18
Intermittent Communication Failure 17
Retraction Problem 16
Failure to Read Input Signal 16
Migration or Expulsion of Device 15
Overheating of Device 15
Circuit Failure 15
Component Missing 15
Defective Component 15
Detachment of Device or Device Component 14
Increase in Pressure 14
Device Operates Differently Than Expected 14
Pumping Problem 13
No Apparent Adverse Event 12
Volume Accuracy Problem 11
Failure to Run on Battery 10
Detachment Of Device Component 10
Device Damaged Prior to Use 10
Inaccurate Synchronization 9
Device Sensing Problem 9
Failure to Advance 9
Device Handling Problem 8
Failure to Unfold or Unwrap 8
Material Separation 8
Battery Problem: Low Impedance 8
Infusion or Flow Problem 8
Fracture 8
Backflow 7
Mechanical Jam 7
Fitting Problem 7
Physical Resistance 7
Aspiration Issue 7
Material Twisted/Bent 7
Image Display Error/Artifact 6
Total Device Problems 6954

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc I Jun-26-2020
2 Arrow International Inc II Mar-10-2015
3 Arrow International Inc II Mar-02-2015
4 Arrow International, Inc., Division of Teleflex Medical Inc. I Mar-11-2016
5 Datascope Corp. I Jul-16-2019
6 Datascope Corporation II Feb-02-2020
7 Datascope Corporation II Jul-12-2019
8 Datascope Corporation II Oct-11-2018
9 Datascope Corporation II Apr-16-2018
10 Datascope Corporation II Jun-08-2016
11 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
12 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
13 Maquet Datascope Corp - Cardiac Assist Division I Sep-05-2017
14 Maquet Datascope Corp - Cardiac Assist Division I Jun-23-2017
15 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
16 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
17 Maquet Datascope Corp - Cardiac Assist Division II Feb-23-2015
18 Maquet Datascope Corp - Cardiac Assist Division II Feb-07-2015

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