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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
  1.  K221339  Paladin Carotid Post-Dilation Balloon System with ...
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
WAVE MEDICAL AG
  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 2091 2093
2026 1218 1218

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8618 8625
Burst Container or Vessel 1869 1869
Difficult to Remove 867 872
Leak/Splash 838 839
Detachment of Device or Device Component 745 747
Break 446 448
Adverse Event Without Identified Device or Use Problem 435 437
Inflation Problem 413 413
Deflation Problem 413 415
Material Deformation 327 328
Material Separation 316 316
Difficult to Advance 251 251
Failure to Advance 163 163
Improper or Incorrect Procedure or Method 160 161
Material Split, Cut or Torn 154 154
Entrapment of Device 151 151
Fluid/Blood Leak 122 122
Material Puncture/Hole 112 112
Material Twisted/Bent 104 104
Device-Device Incompatibility 99 100
Fracture 93 93
Material Integrity Problem 81 81
Stretched 63 63
Difficult to Insert 58 59
Retraction Problem 52 53
Difficult to Open or Remove Packaging Material 48 49
Failure to Deflate 47 48
Device Dislodged or Dislocated 44 45
Off-Label Use 43 43
Use of Device Problem 42 42
Material Frayed 42 42
Device Contamination with Chemical or Other Material 36 36
Deformation Due to Compressive Stress 30 30
Failure to Fold 28 29
Partial Blockage 28 28
Device Damaged Prior to Use 27 27
Device Markings/Labelling Problem 26 27
Packaging Problem 26 26
Crack 24 24
Device Damaged by Another Device 21 21
Peeled/Delaminated 20 20
Device Handling Problem 19 19
Material Fragmentation 17 17
Nonstandard Device 16 16
Device Contaminated During Manufacture or Shipping 16 16
Tear, Rip or Hole in Device Packaging 16 16
Component Missing 16 17
Mechanical Jam 11 13
Difficult to Open or Close 11 11
Contamination 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10944 10961
No Consequences Or Impact To Patient 2159 2159
Foreign Body In Patient 241 241
Insufficient Information 206 207
Vascular Dissection 182 182
Perforation of Vessels 67 67
Device Embedded In Tissue or Plaque 65 65
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 57 57
No Patient Involvement 57 57
Embolism/Embolus 52 53
Hemorrhage/Blood Loss/Bleeding 49 49
Thrombosis/Thrombus 47 47
Obstruction/Occlusion 46 46
Stenosis 45 45
Hematoma 41 41
No Known Impact Or Consequence To Patient 35 37
Restenosis 32 32
Pain 28 28
Injury 23 23
Unspecified Tissue Injury 22 22
No Code Available 18 18
Pseudoaneurysm 13 13
Stroke/CVA 12 12
Unspecified Infection 11 11
Fistula 11 11
Perforation 11 11
Great Vessel Perforation 10 10
Extravasation 10 10
Vasoconstriction 9 9
Embolism 8 8
Swelling/ Edema 7 7
Rupture 7 7
Sepsis 7 7
Myocardial Infarction 6 6
Ischemia 6 6
Calcium Deposits/Calcification 6 6
Needle Stick/Puncture 5 5
Arrhythmia 5 5
Aneurysm 5 5
Renal Failure 5 5
Occlusion 5 5
High Blood Pressure/ Hypertension 4 4
Pulmonary Embolism 4 4
Intimal Dissection 4 4
Thrombus 4 4
Low Blood Pressure/ Hypotension 4 4
Thrombosis 4 4
Numbness 4 4
No Information 4 4
Vessel Or Plaque, Device Embedded In 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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