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TPLC
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show TPLC since
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Device
clamp, vascular
Product Code
DXC
Regulation Number
870.4450
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOREP TECHNOLOGIES, INC
SUBSTANTIALLY EQUIVALENT
1
CAREFUSION 2200 INC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES LLC
SUBSTANTIALLY EQUIVALENT
1
ENSITE VACULAR, LLC
SUBSTANTIALLY EQUIVALENT
1
ENSITE VASCULAR
SUBSTANTIALLY EQUIVALENT
2
MEDICAL INGENUITIES
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
TERUMO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TRICOL BIOMEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
TZ MEDICAL INC
SUBSTANTIALLY EQUIVALENT
1
VASCULAR GRAFT SOLUTIONS, LTD.
SUBSTANTIALLY EQUIVALENT
1
VASOINNOVATIONS INC.
SUBSTANTIALLY EQUIVALENT
1
VASOINNOVATIONS, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
416
416
2018
391
391
2019
393
393
2020
404
404
2021
371
371
2022
129
129
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fitting Problem
404
404
Activation Problem
216
216
Device Operates Differently Than Expected
180
180
Failure to Unfold or Unwrap
109
109
Activation, Positioning or SeparationProblem
87
87
Adverse Event Without Identified Device or Use Problem
77
77
Difficult to Open or Close
76
76
Gas Leak
75
75
Break
73
73
Positioning Failure
64
64
Leak/Splash
63
63
Crack
60
60
Air Leak
56
56
Appropriate Term/Code Not Available
51
51
Insufficient Information
47
47
Inflation Problem
45
45
Mechanical Problem
33
33
Deflation Problem
32
32
Material Rupture
31
31
Device Contamination with Chemical or Other Material
30
30
Unraveled Material
26
26
Premature Activation
25
25
Detachment of Device or Device Component
24
24
Detachment Of Device Component
24
24
No Apparent Adverse Event
16
16
Failure to Advance
15
15
Migration or Expulsion of Device
15
15
Burst Container or Vessel
15
15
Misfire
14
14
Difficult to Insert
14
14
Positioning Problem
14
14
Material Puncture/Hole
13
13
Material Separation
13
13
Material Twisted/Bent
13
13
Sticking
11
11
Use of Device Problem
11
11
Fluid Leak
11
11
Unintended Deflation
10
10
Device Displays Incorrect Message
10
10
Failure to Fire
10
10
Material Deformation
9
9
Decrease in Pressure
9
9
Firing Problem
9
9
Loss of or Failure to Bond
8
8
Filling Problem
8
8
Defective Device
8
8
Defective Component
8
8
Improper or Incorrect Procedure or Method
8
8
Physical Resistance/Sticking
8
8
Failure to Cut
7
7
Structural Problem
7
7
Loose or Intermittent Connection
6
6
Component Falling
6
6
Entrapment of Device
6
6
Difficult to Remove
6
6
Device Operational Issue
5
5
Migration
5
5
Component Missing
5
5
Therapeutic or Diagnostic Output Failure
5
5
Device Dislodged or Dislocated
4
4
Device Difficult to Setup or Prepare
4
4
Difficult or Delayed Positioning
4
4
Pressure Problem
4
4
Difficult to Fold, Unfold or Collapse
4
4
Peeled/Delaminated
4
4
Device Issue
4
4
Hole In Material
3
3
Infusion or Flow Problem
3
3
Mechanical Jam
3
3
Protective Measures Problem
3
3
Device Inoperable
3
3
Unintended Movement
3
3
No Pressure
3
3
Device Fell
3
3
Delivered as Unsterile Product
3
3
Malposition of Device
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Device Slipped
3
3
Failure to Align
3
3
Material Split, Cut or Torn
3
3
Incorrect, Inadequate or Imprecise Resultor Readings
2
2
Retraction Problem
2
2
Deformation Due to Compressive Stress
2
2
Output Problem
2
2
Packaging Problem
2
2
Device Expiration Issue
2
2
Activation Failure
2
2
Unable to Obtain Readings
2
2
Patient Device Interaction Problem
2
2
Physical Resistance
2
2
Uncoiled
2
2
Fracture
2
2
Unsealed Device Packaging
1
1
Complete Blockage
1
1
Component Incompatible
1
1
Bent
1
1
Out-Of-Box Failure
1
1
Incomplete or Missing Packaging
1
1
Expiration Date Error
1
1
Separation Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
662
662
No Known Impact Or Consequence To Patient
583
583
No Clinical Signs, Symptoms or Conditions
417
417
Blood Loss
132
132
No Patient Involvement
113
113
Hematoma
77
77
No Information
59
59
Hemorrhage/Bleeding
50
50
Insufficient Information
21
21
No Code Available
14
14
Injury
14
14
Death
12
12
Aortic Dissection
8
8
Foreign Body In Patient
7
7
Hemostasis
7
7
Vascular Dissection
6
6
Device Embedded In Tissue or Plaque
5
5
Pseudoaneurysm
5
5
Pain
5
5
Laceration(s)
4
4
Failure to Anastomose
4
4
Perforation
2
2
Rupture
2
2
Stroke/CVA
2
2
Occlusion
2
2
Swelling
2
2
Tissue Damage
2
2
Ventricular Fibrillation
2
2
Patient Problem/Medical Problem
2
2
Swelling/ Edema
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Multiple Organ Failure
1
1
Embolism/Embolus
1
1
Great Vessel Perforation
1
1
Diminished Pulse Pressure
1
1
Not Applicable
1
1
Skin Tears
1
1
Burn, Thermal
1
1
Ascites
1
1
Numbness
1
1
Loss of consciousness
1
1
Pallor
1
1
Thrombosis
1
1
Stenosis
1
1
Discomfort
1
1
Renal Failure
1
1
Respiratory Distress
1
1
Necrosis
1
1
Diarrhea
1
1
Ecchymosis
1
1
Vessel Or Plaque, Device Embedded In
1
1
Intimal Dissection
1
1
Abdominal Pain
1
1
Air Embolism
1
1
Bacterial Infection
1
1
Bradycardia
1
1
Bruise/Contusion
1
1
Burn(s)
1
1
Cardiac Arrest
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Failure of Implant
1
1
Unspecified Infection
1
1
Ischemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Apr-29-2022
2
Edwards Lifesciences, LLC
I
Jun-11-2019
3
Edwards Lifesciences, LLC
II
Apr-06-2019
4
Edwards Lifesciences, LLC
II
May-24-2018
5
Integra LifeSciences Corp.
II
Aug-30-2019
6
Merit Medical Systems, Inc.
II
Apr-24-2020
7
Merit Medical Systems, Inc.
II
Apr-10-2017
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