TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
ARC TRAUMA, LLC
	SUBSTANTIALLY EQUIVALENT	1
BEIJING DEMAX MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOREP TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION 2200, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMPRESSION WORKS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	1
ENSITE VACULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENSITE VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
KONO SEISAKUSHO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INGENUITIES
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DIZEGENS MEDICAL SCIENCE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TW MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TZ MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR GRAFT SOLUTIONS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
VASOINNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fitting Problem	735	736
Gas/Air Leak	567	567
Activation Problem	356	356
Deflation Problem	280	280
Unintended Deflation	215	215
Failure to Unfold or Unwrap	147	147
Adverse Event Without Identified Device or Use Problem	121	121
Difficult to Open or Close	98	98
Break	91	91
Detachment of Device or Device Component	78	78
Insufficient Information	73	73
Crack	46	46
Leak/Splash	45	45
No Apparent Adverse Event	32	32
Inflation Problem	32	32
Failure to Seal	29	29
Mechanical Problem	28	28
Unraveled Material	25	25
Filling Problem	22	22
Premature Activation	21	21
Contamination	21	21
Material Puncture/Hole	20	20
Material Twisted/Bent	17	17
Device Slipped	16	16
Activation, Positioning or Separation Problem	16	16
Use of Device Problem	15	15
Material Separation	13	13
Material Rupture	11	11
Fluid/Blood Leak	10	10
Failure to Cut	9	9
Unintended Movement	9	9
Patient Device Interaction Problem	8	8
Migration	7	7
Defective Device	6	8
Burst Container or Vessel	6	6
Positioning Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Improper or Incorrect Procedure or Method	5	5
Device Contaminated During Manufacture or Shipping	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Device Contamination with Chemical or Other Material	5	5
Delivered as Unsterile Product	5	5
Failure to Deflate	5	5
Device Dislodged or Dislocated	5	5
Appropriate Term/Code Not Available	5	5
Electrical /Electronic Property Problem	4	4
Material Split, Cut or Torn	4	4
Misfire	4	4
Failure to Align	4	4
Infusion or Flow Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1956	1957
No Consequences Or Impact To Patient	334	334
Hematoma	236	236
Hemorrhage/Bleeding	209	209
Insufficient Information	142	144
No Patient Involvement	33	33
Blood Loss	29	29
Pain	24	24
Swelling/ Edema	21	21
Bruise/Contusion	18	18
Pseudoaneurysm	12	12
Injury	12	12
Numbness	10	10
Death	7	7
Foreign Body In Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Nerve Damage	6	6
Necrosis	5	5
Vascular Dissection	5	5
Laceration(s)	5	5
No Known Impact Or Consequence To Patient	5	5
Diminished Pulse Pressure	4	4
Obstruction/Occlusion	4	4
Great Vessel Perforation	3	3
Unspecified Tissue Injury	3	3
Perforation of Vessels	3	3
Thrombosis/Thrombus	3	3
Cardiac Arrest	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Neuropathy	3	3
Unspecified Infection	3	3
Cyanosis	3	3
Ventricular Fibrillation	2	2
Fluid Discharge	2	2
No Code Available	2	2
Cardiovascular Insufficiency	2	2
Unspecified Heart Problem	2	2
Nervous System Injury	2	2
Air Embolism	2	2
Aortic Dissection	1	1
Easy Bruising	1	1
Blister	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Pallor	1	1
Burn, Thermal	1	1
Embolism/Embolus	1	1
Perforation	1	1
Erythema	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-12-2024
2	Baxter Healthcare Corporation	II	Jan-05-2024
3	Baxter Healthcare Corporation	II	Apr-29-2022
4	Maquet Cardiovascular, LLC	II	Sep-18-2025
5	Merit Medical Systems, Inc.	II	Apr-24-2020
6	North American Rescue LLC.	II	Sep-26-2025