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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
  1.  K252512  Armada™ 14 NC PTA Catheter
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 2093 2095
2026 507 507

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 8239 8246
Burst Container or Vessel 1792 1792
Difficult to Remove 834 839
Leak/Splash 800 801
Detachment of Device or Device Component 714 716
Break 458 461
Adverse Event Without Identified Device or Use Problem 412 414
Deflation Problem 395 397
Inflation Problem 390 390
Material Deformation 315 316
Material Separation 312 312
Difficult to Advance 239 239
Improper or Incorrect Procedure or Method 156 157
Failure to Advance 156 156
Entrapment of Device 149 149
Material Split, Cut or Torn 146 146
Fluid/Blood Leak 110 110
Material Puncture/Hole 110 110
Material Twisted/Bent 104 104
Device-Device Incompatibility 95 96
Fracture 90 90
Material Integrity Problem 81 81
Stretched 65 65
Difficult to Insert 54 55
Retraction Problem 52 53
Failure to Deflate 47 48
Difficult to Open or Remove Packaging Material 46 47
Device Dislodged or Dislocated 44 45
Off-Label Use 42 42
Material Frayed 41 41
Use of Device Problem 38 38
Device Contamination with Chemical or Other Material 33 33
Partial Blockage 29 29
Deformation Due to Compressive Stress 27 27
Device Damaged Prior to Use 27 27
Device Markings/Labelling Problem 26 27
Packaging Problem 25 25
Crack 23 23
Failure to Fold 23 24
Device Damaged by Another Device 22 22
Device Handling Problem 19 19
Peeled/Delaminated 18 18
Material Fragmentation 18 18
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
Defective Component 10 10
Contamination 10 10
Mechanical Jam 10 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10270 10287
No Consequences Or Impact To Patient 2159 2159
Foreign Body In Patient 222 222
Insufficient Information 198 199
Vascular Dissection 178 178
Device Embedded In Tissue or Plaque 65 65
Perforation of Vessels 64 64
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 57
No Patient Involvement 57 57
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
Fistula 11 11
Unspecified Infection 10 10
Extravasation 10 10
Perforation 10 10
Great Vessel Perforation 10 10
Vasoconstriction 9 9
Embolism 8 8
Swelling/ Edema 7 7
Sepsis 7 7
Calcium Deposits/Calcification 6 6
Ischemia 6 6
Myocardial Infarction 6 6
Rupture 6 6
Renal Failure 5 5
Needle Stick/Puncture 5 5
Aneurysm 5 5
Occlusion 5 5
Arrhythmia 5 5
Thrombus 4 4
Low Blood Pressure/ Hypotension 4 4
Thrombosis 4 4
No Information 4 4
Intimal Dissection 4 4
Pulmonary Embolism 4 4
High Blood Pressure/ Hypertension 4 4
Cardiac Arrest 3 3
Necrosis 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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