• 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 catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
AMECO MEDICAL INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX,
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 8
COOK CORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDCOMP (MEDICAL COMPONENTS)
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP (MEDICAL COMPONENTS, INC.)
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
  SUBSTANTIALLY EQUIVALENT 2
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 5
NOSTIX LLC
  SUBSTANTIALLY EQUIVALENT 1
ROMEDEX INTERNATIONAL SRL
  SUBSTANTIALLY EQUIVALENT 1
VYGON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid Leak 585
Break 316
Leak / Splash 242
Fracture 174
Crack 142
Material Separation 134
Material Deformation 122
Detachment of Device or device Component 96
Deformation Due to Compressive Stress 95
Adverse Event Without Identified Device or Use Problem 84
Material Fragmentation 72
Split 64
Occlusion Within Device 59
Device Dislodged or Dislocated 55
Unraveled Material 50
Catheter 47
Detachment Of Device Component 45
Burst Container or Vessel 44
Kinked 43
Hole In Material 40
Difficult to Remove 39
Material Rupture 37
Mushroomed 33
Physical Resistance 33
Defective Component 33
Appropriate Term/Code Not Available 33
Material Frayed 33
Failure to Infuse 27
Difficult to Advance 23
Device Damaged Prior to Use 19
Material Split, Cut or Torn 19
Material Puncture / Hole 19
Material Integrity Problem 19
Migration or Expulsion of Device 19
Device Operates Differently Than Expected 17
Failure to Advance 17
Knotted 17
Guidewire 16
Partial Blockage 15
Device Markings / Labelling Problem 15
Separation Failure 13
Complete Blockage 11
Insufficient Information 11
Activation, Positioning or Separation Problem 11
Obstruction of Flow 11
Difficult to Flush 10
Suction Problem 10
Backflow 10
Uncoiled 9
Material Twisted / Bent 9
Malposition of device 9
Physical Resistance / Sticking 9
Device Contamination with Chemical or Other Material 8
Fitting Problem 8
Cut In Material 8
Bent 8
Infusion or Flow Problem 8
Migration 7
Connection Problem 7
Stretched 7
Device Issue 7
Aspiration Issue 6
Use of Device Problem 6
Component Missing 5
Tear, Rip or Hole in Device Packaging 5
Sticking 5
Incomplete or Missing Packaging 5
Torn Material 5
Entrapment of Device 5
Positioning Problem 5
Defective Device 4
Material Perforation 4
Air Leak 4
Wrinkled 4
Unknown (for use when the device problem is not known) 4
Wire 4
Tip 3
Physical Property Issue 3
Improper or Incorrect Procedure or Method 3
Product Quality Problem 3
Patient Device Interaction Problem 3
Unsealed Device Packaging 3
Pressure Problem 3
Reflux within Device 3
Peeled / Delaminated 3
Collapse 3
Separation Problem 3
Hub 3
Loose or Intermittent Connection 3
Component Falling 2
Disconnection 2
Restricted Flow rate 2
Difficult to Insert 2
Material Distortion 2
Material Too Soft / Flexible 2
Other (for use when an appropriate device code cannot be identified) 2
Decrease in Pressure 2
Unintended Movement 2
Folded 2
Contamination During Use 2
Total Device Problems 3315

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-11-2018
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Jun-14-2018
3 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-14-2017
4 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-07-2016
5 Angiodynamics Inc. (Navilyst Medical Inc.) II Dec-05-2016
6 Arrow International Inc II Jun-16-2019
7 Arrow International Inc II May-16-2019
8 Arrow International Inc II Sep-19-2018
9 Arrow International Inc II Jul-08-2018
10 Arrow International Inc II May-30-2018
11 Arrow International Inc II Apr-10-2018
12 Arrow International Inc II Mar-14-2018
13 Arrow International Inc II Feb-22-2018
14 Arrow International Inc II Feb-13-2018
15 Arrow International Inc II Nov-28-2017
16 Arrow International Inc II Jun-27-2017
17 Arrow International Inc II Jun-12-2017
18 Arrow International Inc II Mar-08-2017
19 Arrow International Inc II Feb-22-2017
20 Arrow International Inc II Sep-09-2016
21 Arrow International Inc II Nov-04-2015
22 Arrow International Inc II Oct-15-2015
23 Arrow International Inc II Aug-25-2015
24 Arrow International Inc II Apr-24-2014
25 Bard Access Systems II Sep-23-2015
26 Bard Access Systems III Jul-08-2015
27 Bard Access Systems II Mar-13-2015
28 Bard Access Systems Inc. II Feb-06-2018
29 Navilyst Medical, Inc II Oct-07-2014
30 Navilyst Medical, Inc., an AngioDyamics Company II Jun-14-2016
31 Pfm Medical Inc II Dec-12-2014
32 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. II Feb-21-2018

-
-