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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
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 1040 1040

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8508 8515
Burst Container or Vessel 1846 1846
Difficult to Remove 863 868
Leak/Splash 829 830
Detachment of Device or Device Component 735 737
Break 441 443
Adverse Event Without Identified Device or Use Problem 431 433
Deflation Problem 408 410
Inflation Problem 405 405
Material Deformation 325 326
Material Separation 315 315
Difficult to Advance 251 251
Failure to Advance 162 162
Improper or Incorrect Procedure or Method 159 160
Material Split, Cut or Torn 153 153
Entrapment of Device 150 150
Fluid/Blood Leak 121 121
Material Puncture/Hole 112 112
Material Twisted/Bent 103 103
Device-Device Incompatibility 99 100
Fracture 89 89
Material Integrity Problem 81 81
Stretched 61 61
Difficult to Insert 56 57
Retraction Problem 52 53
Failure to Deflate 47 48
Difficult to Open or Remove Packaging Material 46 47
Off-Label Use 43 43
Material Frayed 42 42
Use of Device Problem 42 42
Device Dislodged or Dislocated 42 43
Device Contamination with Chemical or Other Material 35 35
Deformation Due to Compressive Stress 30 30
Partial Blockage 28 28
Device Damaged Prior to Use 27 27
Packaging Problem 26 26
Device Markings/Labelling Problem 25 26
Failure to Fold 24 25
Crack 24 24
Device Damaged by Another Device 21 21
Peeled/Delaminated 19 19
Device Handling Problem 19 19
Tear, Rip or Hole in Device Packaging 16 16
Material Fragmentation 16 16
Component Missing 16 17
Nonstandard Device 15 15
Device Contaminated During Manufacture or Shipping 15 15
Mechanical Jam 11 13
Contamination 10 10
Defective Component 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10775 10792
No Consequences Or Impact To Patient 2159 2159
Foreign Body In Patient 235 235
Insufficient Information 205 206
Vascular Dissection 181 181
Perforation of Vessels 67 67
Device Embedded In Tissue or Plaque 65 65
No Patient Involvement 57 57
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 57 57
Embolism/Embolus 52 53
Hemorrhage/Blood Loss/Bleeding 49 49
Thrombosis/Thrombus 46 46
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 12 12
Stroke/CVA 12 12
Perforation 11 11
Fistula 11 11
Extravasation 10 10
Great Vessel Perforation 10 10
Unspecified Infection 10 10
Vasoconstriction 9 9
Embolism 8 8
Sepsis 7 7
Swelling/ Edema 7 7
Ischemia 6 6
Rupture 6 6
Myocardial Infarction 6 6
Calcium Deposits/Calcification 6 6
Arrhythmia 5 5
Renal Failure 5 5
Needle Stick/Puncture 5 5
Occlusion 5 5
Aneurysm 5 5
Pulmonary Embolism 4 4
Intimal Dissection 4 4
Thrombosis 4 4
High Blood Pressure/ Hypertension 4 4
Low Blood Pressure/ Hypotension 4 4
Numbness 4 4
No Information 4 4
Thrombus 4 4
Failure of Implant 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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