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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
2018
277
277
2019
196
196
2020
198
198
2021
383
383
2022
478
478
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
320
320
Fracture
233
233
Fluid/Blood Leak
176
176
Adverse Event Without Identified Device or Use Problem
106
106
Leak/Splash
66
66
Crack
61
61
Material Separation
57
57
Infusion or Flow Problem
52
52
Device Contamination with Chemical or Other Material
51
51
Material Fragmentation
49
49
Dull, Blunt
46
46
Defective Component
45
45
Suction Problem
38
38
Appropriate Term/Code Not Available
37
37
Detachment of Device or Device Component
31
31
Disconnection
30
30
Device Contaminated During Manufacture or Shipping
25
25
No Apparent Adverse Event
25
25
Contamination /Decontamination Problem
22
22
Entrapment of Device
21
21
Unraveled Material
21
21
Difficult to Remove
20
20
Material Split, Cut or Torn
16
16
Material Deformation
12
12
Use of Device Problem
11
11
Obstruction of Flow
10
10
Misassembled
10
10
Material Integrity Problem
10
10
Physical Resistance/Sticking
10
10
Component Misassembled
10
10
Restricted Flow rate
9
9
Improper or Incorrect Procedure or Method
9
9
Material Puncture/Hole
9
9
Particulates
8
8
Fitting Problem
8
8
Deformation Due to Compressive Stress
8
8
Failure to Advance
7
7
Migration or Expulsion of Device
7
7
Material Frayed
6
6
Nonstandard Device
6
6
Loose or Intermittent Connection
6
6
Mechanical Problem
6
6
Partial Blockage
6
6
Tear, Rip or Hole in Device Packaging
6
6
Material Twisted/Bent
6
6
Suction Failure
6
6
Defective Device
5
5
Device Operates Differently Than Expected
5
5
Kinked
5
5
Failure to Read Input Signal
5
5
Material Rupture
4
4
Device Damaged Prior to Use
4
4
Complete Blockage
4
4
Decrease in Suction
4
4
Detachment Of Device Component
4
4
Contamination
4
4
Flaked
4
4
Device Dislodged or Dislocated
4
4
Material Protrusion/Extrusion
4
4
Insufficient Information
4
4
No Flow
3
3
Packaging Problem
3
3
Material Too Soft/Flexible
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Difficult to Advance
3
3
Malposition of Device
3
3
Device Markings/Labelling Problem
3
3
Aspiration Issue
3
3
Collapse
3
3
Difficult to Insert
3
3
Disassembly
3
3
Component Missing
3
3
Sticking
3
3
Device Slipped
2
2
Material Perforation
2
2
Failure to Infuse
2
2
Unsealed Device Packaging
2
2
Material Too Rigid or Stiff
2
2
Peeled/Delaminated
2
2
Off-Label Use
2
2
Product Quality Problem
2
2
Corroded
2
2
Loss of or Failure to Bond
2
2
Difficult to Fold, Unfold or Collapse
2
2
Delivered as Unsterile Product
2
2
Patient-Device Incompatibility
2
2
Physical Resistance
2
2
Patient Device Interaction Problem
2
2
Migration
2
2
Positioning Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Torn Material
2
2
Device Fell
2
2
Unclear Information
2
2
Missing Information
1
1
Air/Gas in Device
1
1
Incomplete or Inadequate Connection
1
1
Separation Problem
1
1
Illegible Information
1
1
Physical Property Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
683
683
No Consequences Or Impact To Patient
310
310
No Known Impact Or Consequence To Patient
184
184
Foreign Body In Patient
143
143
No Patient Involvement
73
73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
47
47
Not Applicable
44
44
No Code Available
41
41
Insufficient Information
30
30
Unspecified Infection
25
25
Device Embedded In Tissue or Plaque
23
23
Pneumothorax
19
19
Fistula
18
18
Failure to Anastomose
17
17
Hematoma
16
16
Pain
16
16
Hemorrhage/Bleeding
15
15
Seroma
15
15
No Information
14
14
Patient Problem/Medical Problem
11
11
Injury
9
9
Post Operative Wound Infection
9
9
Wound Dehiscence
9
9
Endophthalmitis
9
9
Inflammation
8
8
Pleural Effusion
8
8
Toxic Anterior Segment Syndrome (TASS)
8
8
Bacterial Infection
7
7
Abscess
6
6
Pneumonia
6
6
Failure of Implant
6
6
Obstruction/Occlusion
6
6
Capsular Bag Tear
6
6
Blood Loss
6
6
Sepsis
5
5
Death
5
5
Necrosis
5
5
Erythema
4
4
Uveitis
4
4
Impaired Healing
3
3
Cardiac Tamponade
3
3
Conjunctivitis
3
3
Atrial Fibrillation
3
3
Low Blood Pressure/ Hypotension
3
3
Hypoxia
3
3
Fever
2
2
Hemothorax
2
2
Hypopyon
2
2
Nerve Damage
2
2
Corneal Edema
2
2
Cellulitis
2
2
Chest Pain
2
2
Dehydration
2
2
Dyspnea
2
2
Tachycardia
2
2
Vomiting
2
2
Discomfort
2
2
Blurred Vision
2
2
Paresis
2
2
Fluid Discharge
2
2
Pericardial Effusion
2
2
Thrombosis/Thrombus
1
1
Respiratory Insufficiency
1
1
Eye Pain
1
1
Intraocular Pressure Decreased
1
1
Pseudoaneurysm
1
1
Tissue Breakdown
1
1
Angioedema
1
1
Swelling/ Edema
1
1
Rash
1
1
Renal Failure
1
1
Respiratory Distress
1
1
Scar Tissue
1
1
Visual Impairment
1
1
Loss of Vision
1
1
Vitreous Loss
1
1
Septic Shock
1
1
Skin Irritation
1
1
Tissue Damage
1
1
Urinary Tract Infection
1
1
Hernia
1
1
Wheal(s)
1
1
Infection, Pyrogenic
1
1
Ulcer
1
1
Pressure Sores
1
1
Fasciitis
1
1
Post Traumatic Wound Infection
1
1
Low Oxygen Saturation
1
1
Cardiac Perforation
1
1
Eye Burn
1
1
Confusion/ Disorientation
1
1
Vascular System (Circulation), Impaired
1
1
Extravasation
1
1
Crushing Injury
1
1
Adhesion(s)
1
1
Cardiac Arrest
1
1
Cardiopulmonary Arrest
1
1
Abdominal Pain
1
1
Abnormal Blood Gases
1
1
Internal Organ Perforation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
II
Jan-18-2023
2
Cardinal Health 200, LLC
II
Jul-18-2018
3
Centese Inc.
II
Oct-13-2021
4
Cook Inc.
II
Mar-24-2020
5
Degania Silicone, Ltd.
II
Aug-12-2019
6
Degania Silicone, Ltd.
III
Feb-20-2018
7
Maquet Cardiovascular, LLC
II
Jan-19-2023
8
TELEFLEX MEDICAL INC
II
Mar-24-2021
9
TELEFLEX MEDICAL INC
II
Aug-28-2020
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