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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, angioplasty, peripheral, transluminal
Regulation Description Percutaneous catheter.
Product CodeLIT
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BROSMED MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONTEGO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CORDIS US CORP
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL LTD. DBA SURMODICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CREAGH MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
DK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN, LLC)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATEC MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEXSTEP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
QUALIMED USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SILK ROAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
SUMMA THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2443 2445
2021 2492 2493
2022 2155 2157
2023 1807 1813
2024 1913 1919
2025 2092 2094
2026 722 722

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8363 8370
Burst Container or Vessel 1819 1819
Difficult to Remove 843 848
Leak/Splash 814 815
Detachment of Device or Device Component 724 726
Break 460 463
Adverse Event Without Identified Device or Use Problem 421 423
Deflation Problem 400 402
Inflation Problem 398 398
Material Deformation 318 319
Material Separation 316 316
Difficult to Advance 243 243
Improper or Incorrect Procedure or Method 157 158
Failure to Advance 157 157
Entrapment of Device 155 155
Material Split, Cut or Torn 148 148
Fluid/Blood Leak 117 117
Material Puncture/Hole 111 111
Material Twisted/Bent 104 104
Device-Device Incompatibility 97 98
Fracture 93 93
Material Integrity Problem 81 81
Stretched 65 65
Difficult to Insert 56 57
Retraction Problem 52 53
Failure to Deflate 47 48
Difficult to Open or Remove Packaging Material 46 47
Device Dislodged or Dislocated 45 46
Off-Label Use 43 43
Material Frayed 41 41
Use of Device Problem 40 40
Device Contamination with Chemical or Other Material 35 35
Deformation Due to Compressive Stress 29 29
Partial Blockage 29 29
Device Damaged Prior to Use 27 27
Device Markings/Labelling Problem 26 27
Packaging Problem 25 25
Crack 24 24
Failure to Fold 23 24
Device Damaged by Another Device 22 22
Device Handling Problem 19 19
Peeled/Delaminated 19 19
Material Fragmentation 19 19
Component Missing 18 19
Tear, Rip or Hole in Device Packaging 14 14
Device Contaminated During Manufacture or Shipping 14 14
Physical Resistance/Sticking 12 12
Nonstandard Device 11 11
Defective Component 10 10
Contamination 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10470 10487
No Consequences Or Impact To Patient 2159 2159
Foreign Body In Patient 228 228
Insufficient Information 199 200
Vascular Dissection 179 179
Perforation of Vessels 66 66
Device Embedded In Tissue or Plaque 65 65
No Patient Involvement 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
Embolism/Embolus 52 53
Hemorrhage/Bleeding 49 49
Thrombosis/Thrombus 45 45
Stenosis 45 45
Obstruction/Occlusion 45 45
Hematoma 41 41
No Known Impact Or Consequence To Patient 35 37
Restenosis 32 32
Pain 27 27
Injury 23 23
Unspecified Tissue Injury 22 22
No Code Available 18 18
Pseudoaneurysm 12 12
Stroke/CVA 12 12
Perforation 11 11
Fistula 11 11
Great Vessel Perforation 10 10
Extravasation 10 10
Unspecified Infection 10 10
Vasoconstriction 9 9
Embolism 8 8
Swelling/ Edema 7 7
Sepsis 7 7
Ischemia 6 6
Rupture 6 6
Myocardial Infarction 6 6
Calcium Deposits/Calcification 6 6
Occlusion 5 5
Aneurysm 5 5
Needle Stick/Puncture 5 5
Arrhythmia 5 5
Renal Failure 5 5
No Information 4 4
Low Blood Pressure/ Hypotension 4 4
Thrombus 4 4
Intimal Dissection 4 4
Pulmonary Embolism 4 4
Thrombosis 4 4
High Blood Pressure/ Hypertension 4 4
Shock 3 3
Reocclusion 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jan-30-2020
2 Boston Scientific Corporation II Jan-09-2026
3 Cordis Corporation II Aug-09-2021
4 Cordis Corporation II Feb-28-2020
5 Covidien LP II Oct-29-2024
6 Covidien Llc II Feb-03-2022
7 Ostial Corporation II Aug-17-2021
8 SUMMA THERAPEUTICS, LLC II Mar-30-2026
9 ev3 Inc II Jan-15-2025
10 ev3 Inc. II Sep-30-2020
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