TPLC - Total Product Life Cycle

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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
ENSITE VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
KONO SEISAKUSHO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DIZEGENS MEDICAL SCIENCE CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TW MEDICAL
	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	602	603
Gas/Air Leak	469	469
Activation Problem	283	283
Deflation Problem	269	269
Unintended Deflation	144	144
Failure to Unfold or Unwrap	102	102
Adverse Event Without Identified Device or Use Problem	96	96
Difficult to Open or Close	76	76
Break	73	73
Detachment of Device or Device Component	71	71
Insufficient Information	60	60
No Apparent Adverse Event	31	31
Failure to Seal	29	29
Crack	26	26
Mechanical Problem	24	24
Unraveled Material	21	21
Leak/Splash	20	20
Contamination	20	20
Premature Activation	18	18
Material Puncture/Hole	18	18
Inflation Problem	17	17
Device Slipped	16	16
Activation, Positioning or Separation Problem	16	16
Material Twisted/Bent	13	13
Use of Device Problem	11	11
Material Rupture	10	10
Filling Problem	9	9
Unintended Movement	9	9
Patient Device Interaction Problem	8	8
Fluid/Blood Leak	8	8
Material Separation	7	7
Failure to Cut	7	7
Migration	7	7
Defective Device	6	8
Burst Container or Vessel	6	6
Delivered as Unsterile Product	5	5
Device Dislodged or Dislocated	5	5
Improper or Incorrect Procedure or Method	5	5
Failure to Deflate	5	5
Device Contaminated During Manufacture or Shipping	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Therapeutic or Diagnostic Output Failure	4	4
Material Split, Cut or Torn	4	4
Failure to Align	4	4
Device Contamination with Chemical or Other Material	4	4
Infusion or Flow Problem	3	3
Misfire	3	3
Failure to Fire	3	3
Deformation Due to Compressive Stress	3	3
Component Missing	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1826	1827
Hematoma	215	215
Hemorrhage/Bleeding	199	199
Insufficient Information	137	139
No Consequences Or Impact To Patient	42	42
Pain	24	24
Swelling/ Edema	20	20
Bruise/Contusion	17	17
Pseudoaneurysm	11	11
Numbness	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Nerve Damage	6	6
Necrosis	5	5
Foreign Body In Patient	5	5
Vascular Dissection	4	4
Diminished Pulse Pressure	4	4
Obstruction/Occlusion	4	4
Laceration(s)	4	4
No Patient Involvement	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
Cardiovascular Insufficiency	2	2
Unspecified Heart Problem	2	2
Nervous System Injury	2	2
Air Embolism	2	2
Needle Stick/Puncture	1	1
Pallor	1	1
Easy Bruising	1	1
Blister	1	1
Erythema	1	1
Discomfort	1	1
Embolism/Embolus	1	1
Asystole	1	1
Heart Failure/Congestive Heart Failure	1	1
Muscle/Tendon Damage	1	1
Muscle Weakness	1	1
Failure of Implant	1	1
Hypersensitivity/Allergic reaction	1	1
Shock	1	1
High Blood Pressure/ Hypertension	1	1
Aneurysm	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	North American Rescue LLC.	II	Sep-26-2025