TPLC - Total Product Life Cycle

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Device	ablation catheter, renal denervation
Definition	For denervating the renal nerves to lower blood pressure
Product Code	QYI
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	0	3	13	7	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17	17
Difficult to Insert	6	6
Material Deformation	6	6
Expiration Date Error	4	4
Entrapment of Device	3	3
Insufficient Information	3	3
Positioning Problem	3	3
Detachment of Device or Device Component	3	3
Use of Device Problem	2	2
Failure to Cycle	2	2
Incomplete or Inadequate Connection	1	1
Unsealed Device Packaging	1	1
Defective Device	1	2
Difficult to Remove	1	1
High Readings	1	1
Obstruction of Flow	1	1
Device Damaged by Another Device	1	1
Fracture	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11	11
Vascular Dissection	7	7
Thrombosis/Thrombus	4	4
Insufficient Information	3	3
High Blood Pressure/ Hypertension	2	2
Obstruction/Occlusion	2	3
Pain	2	3
Bradycardia	2	2
Abdominal Pain	1	1
Syncope/Fainting	1	1
Stroke/CVA	1	1
Nausea	1	1
Hematoma	1	1
Ischemia	1	1
Malaise	1	1
Embolism/Embolus	1	1
Asystole	1	1
Pseudoaneurysm	1	1
Low Oxygen Saturation	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ReCor Medical Inc.	II	Mar-27-2026