TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
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
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
TERUMOMEDICAL CORPORATION
	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	712	713
Activation Problem	347	347
Gas/Air Leak	338	338
Deflation Problem	250	250
Failure to Unfold or Unwrap	144	144
Adverse Event Without Identified Device or Use Problem	103	103
Difficult to Open or Close	94	94
Break	87	87
Insufficient Information	72	72
Detachment of Device or Device Component	48	48
Crack	46	46
Leak/Splash	45	45
Unintended Deflation	42	42
No Apparent Adverse Event	32	32
Inflation Problem	31	31
Failure to Seal	26	26
Mechanical Problem	25	25
Unraveled Material	25	25
Premature Activation	21	21
Material Puncture/Hole	19	19
Material Twisted/Bent	17	17
Activation, Positioning or Separation Problem	16	16
Device Slipped	13	13
Material Separation	13	13
Use of Device Problem	13	13
Material Rupture	10	10
Fluid/Blood Leak	10	10
Failure to Cut	9	9
Filling Problem	8	8
Unintended Movement	8	8
Migration	7	7
Patient Device Interaction Problem	6	6
Burst Container or Vessel	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Appropriate Term/Code Not Available	5	5
Device Dislodged or Dislocated	5	5
Defective Device	5	7
Device Contamination with Chemical or Other Material	5	5
Delivered as Unsterile Product	5	5
Device Contaminated During Manufacture or Shipping	5	5
Therapeutic or Diagnostic Output Failure	4	4
Failure to Deflate	4	4
Misfire	4	4
Improper or Incorrect Procedure or Method	4	4
Failure to Align	4	4
Material Split, Cut or Torn	4	4
Melted	3	3
Protective Measures Problem	3	5
Electrical /Electronic Property Problem	3	3
Activation Failure	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1632	1633
No Consequences Or Impact To Patient	334	334
Hematoma	182	182
Hemorrhage/Bleeding	180	180
Insufficient Information	131	133
No Patient Involvement	33	33
Blood Loss	29	29
Pain	20	20
Bruise/Contusion	14	14
Injury	12	12
Pseudoaneurysm	11	11
Swelling/ Edema	11	11
Numbness	8	8
Death	7	7
Foreign Body In Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Vascular Dissection	5	5
Necrosis	5	5
Laceration(s)	5	5
No Known Impact Or Consequence To Patient	5	5
Nerve Damage	4	4
Great Vessel Perforation	3	3
Perforation of Vessels	3	3
Thrombosis/Thrombus	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Neuropathy	3	3
Unspecified Infection	3	3
Cyanosis	3	3
Cardiac Arrest	2	2
Ventricular Fibrillation	2	2
Diminished Pulse Pressure	2	2
No Code Available	2	2
Unspecified Heart Problem	2	2
Cardiovascular Insufficiency	2	2
Nervous System Injury	2	2
Aortic Dissection	1	1
Burn(s)	1	1
Pallor	1	1
Needle Stick/Puncture	1	1
Obstruction/Occlusion	1	1
Blister	1	1
Easy Bruising	1	1
Burn, Thermal	1	1
Discomfort	1	1
Erythema	1	1
Embolism/Embolus	1	1
Heart Failure/Congestive Heart Failure	1	1
Muscle/Tendon Damage	1	1
Fluid Discharge	1	1
Perforation	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