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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 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 2089 2091
2026 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8012 8019
Burst Container or Vessel 1767 1767
Difficult to Remove 805 810
Leak/Splash 777 778
Detachment of Device or Device Component 697 699
Break 445 448
Adverse Event Without Identified Device or Use Problem 403 405
Inflation Problem 378 378
Deflation Problem 373 375
Material Deformation 310 311
Material Separation 306 306
Difficult to Advance 225 225
Failure to Advance 156 156
Improper or Incorrect Procedure or Method 150 151
Entrapment of Device 145 145
Material Split, Cut or Torn 141 141
Material Puncture/Hole 106 106
Material Twisted/Bent 103 103
Fluid/Blood Leak 101 101
Device-Device Incompatibility 92 93
Fracture 87 87
Material Integrity Problem 81 81
Stretched 64 64
Difficult to Insert 51 52
Retraction Problem 51 52
Failure to Deflate 46 47
Difficult to Open or Remove Packaging Material 46 47
Device Dislodged or Dislocated 44 45
Off-Label Use 42 42
Material Frayed 40 40
Use of Device Problem 38 38
Device Contamination with Chemical or Other Material 32 32
Partial Blockage 28 28
Device Damaged Prior to Use 27 27
Device Markings/Labelling Problem 26 27
Packaging Problem 25 25
Deformation Due to Compressive Stress 23 23
Crack 23 23
Device Damaged by Another Device 22 22
Failure to Fold 22 23
Device Handling Problem 19 19
Component Missing 18 19
Material Fragmentation 16 16
Peeled/Delaminated 16 16
Tear, Rip or Hole in Device Packaging 14 14
Device Contaminated During Manufacture or Shipping 13 13
Physical Resistance/Sticking 11 11
Defective Component 10 10
Mechanical Jam 10 12
Structural Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9939 9956
No Consequences Or Impact To Patient 2159 2159
Foreign Body In Patient 209 209
Insufficient Information 197 198
Vascular Dissection 175 175
Device Embedded In Tissue or Plaque 64 64
Perforation of Vessels 62 62
No Patient Involvement 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Embolism/Embolus 52 53
Hemorrhage/Bleeding 49 49
Stenosis 45 45
Obstruction/Occlusion 45 45
Thrombosis/Thrombus 42 42
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
Stroke/CVA 12 12
Pseudoaneurysm 12 12
Unspecified Infection 10 10
Fistula 10 10
Extravasation 10 10
Perforation 10 10
Great Vessel Perforation 10 10
Vasoconstriction 9 9
Embolism 8 8
Sepsis 7 7
Swelling/ Edema 7 7
Calcium Deposits/Calcification 6 6
Myocardial Infarction 6 6
Rupture 6 6
Renal Failure 5 5
Aneurysm 5 5
Needle Stick/Puncture 5 5
Ischemia 5 5
Occlusion 5 5
Arrhythmia 5 5
No Information 4 4
Thrombus 4 4
Low Blood Pressure/ Hypotension 4 4
Intimal Dissection 4 4
Thrombosis 4 4
High Blood Pressure/ Hypertension 4 4
Pulmonary Embolism 4 4
Shock 3 3
Bradycardia 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 ev3 Inc II Jan-15-2025
9 ev3 Inc. II Sep-30-2020
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