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TPLC
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Device
catheter, irrigation
Product Code
GBX
Regulation Number
878.4200
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
196
196
2020
198
198
2021
383
383
2022
477
477
2023
629
629
2024
173
173
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
541
541
Break
391
391
Fluid/Blood Leak
188
188
Defective Component
151
151
Material Separation
148
148
Adverse Event Without Identified Device or Use Problem
108
108
Leak/Splash
93
93
Material Fragmentation
74
74
Infusion or Flow Problem
68
68
Dull, Blunt
51
51
Device Contamination with Chemical or Other Material
47
47
Detachment of Device or Device Component
36
36
Device Contaminated During Manufacture or Shipping
34
34
Disconnection
33
33
Suction Problem
33
33
Unraveled Material
27
27
Difficult to Remove
26
26
No Apparent Adverse Event
25
25
Crack
25
25
Contamination /Decontamination Problem
21
21
Material Integrity Problem
20
20
Obstruction of Flow
18
18
Material Split, Cut or Torn
15
15
Deformation Due to Compressive Stress
15
15
Entrapment of Device
15
15
Suction Failure
13
13
Component Misassembled
12
12
Use of Device Problem
10
10
Particulates
9
9
Improper or Incorrect Procedure or Method
9
9
Material Twisted/Bent
9
9
Appropriate Term/Code Not Available
8
8
Restricted Flow rate
8
8
Physical Resistance/Sticking
8
8
Material Deformation
8
8
Fitting Problem
7
7
Material Puncture/Hole
7
7
Migration or Expulsion of Device
7
7
Failure to Advance
6
6
Tear, Rip or Hole in Device Packaging
6
6
Difficult to Insert
6
6
Loose or Intermittent Connection
5
5
Component Missing
5
5
Device Dislodged or Dislocated
4
4
Material Frayed
4
4
Contamination
4
4
Material Rupture
4
4
Decrease in Suction
4
4
Insufficient Information
4
4
Difficult to Fold, Unfold or Collapse
4
4
Material Protrusion/Extrusion
4
4
Complete Blockage
4
4
Air/Gas in Device
3
3
Nonstandard Device
3
3
Defective Device
3
3
Packaging Problem
3
3
Mechanical Problem
3
3
Material Too Soft/Flexible
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Difficult to Advance
3
3
Device Damaged Prior to Use
3
3
Malposition of Device
3
3
Migration
3
3
Misassembled
3
3
Difficult or Delayed Positioning
2
2
Connection Problem
2
2
Loss of or Failure to Bond
2
2
Therapeutic or Diagnostic Output Failure
2
2
No Flow
2
2
Product Quality Problem
2
2
Corroded
2
2
Gas/Air Leak
2
2
Illegible Information
2
2
Patient-Device Incompatibility
2
2
Device Markings/Labelling Problem
2
2
Insufficient Flow or Under Infusion
2
2
Flaked
2
2
Device Slipped
2
2
Separation Problem
2
2
Partial Blockage
2
2
Failure to Infuse
2
2
Unsealed Device Packaging
2
2
Patient Device Interaction Problem
2
2
Off-Label Use
2
2
Device Handling Problem
2
2
Unclear Information
2
2
Expulsion
1
1
Device Emits Odor
1
1
Material Too Rigid or Stiff
1
1
Contamination of Device Ingredient or Reagent
1
1
Incomplete or Inadequate Connection
1
1
Unintended Movement
1
1
Device-Device Incompatibility
1
1
Peeled/Delaminated
1
1
Wrong Label
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Perforation
1
1
Collapse
1
1
Difficult to Open or Remove Packaging Material
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1372
1372
No Consequences Or Impact To Patient
213
213
Foreign Body In Patient
180
180
No Known Impact Or Consequence To Patient
79
79
Insufficient Information
54
54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
54
54
No Patient Involvement
44
44
Unspecified Infection
27
27
No Code Available
25
25
Device Embedded In Tissue or Plaque
19
19
Hematoma
19
19
Not Applicable
18
18
Hemorrhage/Bleeding
17
17
Failure to Anastomose
17
17
Pneumothorax
17
17
Seroma
16
16
Pain
16
16
Fistula
13
13
Endophthalmitis
9
9
Patient Problem/Medical Problem
9
9
Toxic Anterior Segment Syndrome (TASS)
8
8
Failure of Implant
8
8
Inflammation
7
7
Wound Dehiscence
7
7
Bacterial Infection
7
7
Post Operative Wound Infection
7
7
Abscess
6
6
Pleural Effusion
6
6
Necrosis
6
6
Sepsis
5
5
Injury
5
5
Obstruction/Occlusion
5
5
Capsular Bag Tear
4
4
No Information
4
4
Cardiac Tamponade
4
4
Uveitis
4
4
Pneumonia
4
4
Hypoxia
4
4
Atrial Fibrillation
4
4
Fever
4
4
Erythema
3
3
Conjunctivitis
3
3
Low Blood Pressure/ Hypotension
3
3
Abdominal Pain
3
3
Cellulitis
3
3
Impaired Healing
3
3
Blood Loss
3
3
Unspecified Tissue Injury
3
3
Fluid Discharge
2
2
Low Oxygen Saturation
2
2
Vomiting
2
2
Chills
2
2
Blurred Vision
2
2
Tachycardia
2
2
Scar Tissue
2
2
Urinary Tract Infection
2
2
Paresis
2
2
Nerve Damage
2
2
Internal Organ Perforation
2
2
Septic Shock
2
2
Chest Pain
2
2
Death
2
2
Dehydration
2
2
Dyspnea
2
2
Hypopyon
2
2
Corneal Edema
2
2
Crushing Injury
1
1
Extravasation
1
1
Hemothorax
1
1
Itching Sensation
1
1
Nausea
1
1
Endocarditis
1
1
Cardiac Arrest
1
1
Abnormal Blood Gases
1
1
Adhesion(s)
1
1
Rheumatoid Arthritis
1
1
Asthma
1
1
Shock
1
1
Skin Irritation
1
1
Rash
1
1
Renal Failure
1
1
Respiratory Distress
1
1
Paralysis
1
1
Tissue Damage
1
1
Visual Impairment
1
1
Loss of Vision
1
1
Vitreous Loss
1
1
Respiratory Tract Infection
1
1
Hernia
1
1
Wheal(s)
1
1
Pressure Sores
1
1
Anxiety
1
1
Respiratory Failure
1
1
Cardiac Perforation
1
1
Confusion/ Disorientation
1
1
Vascular System (Circulation), Impaired
1
1
Pseudoaneurysm
1
1
Post Traumatic Wound Infection
1
1
Tissue Breakdown
1
1
Swelling/ Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
II
May-01-2024
2
Cardinal Health 200, LLC
II
Jan-18-2023
3
Centese Inc.
II
Oct-13-2021
4
Cook Inc.
II
Mar-24-2020
5
Degania Silicone, Ltd.
II
Aug-12-2019
6
Maquet Cardiovascular, LLC
II
Jan-19-2023
7
TELEFLEX MEDICAL INC
II
Mar-24-2021
8
TELEFLEX MEDICAL INC
II
Aug-28-2020
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