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TPLC
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show TPLC since
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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
704
704
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
799
799
Break
452
452
Fluid/Blood Leak
225
225
Material Separation
222
222
Defective Component
207
207
Adverse Event Without Identified Device or Use Problem
124
124
Leak/Splash
105
105
Material Fragmentation
80
80
Infusion or Flow Problem
74
74
Device Contaminated During Manufacture or Shipping
73
73
Dull, Blunt
54
54
Device Contamination with Chemical or Other Material
48
48
Disconnection
37
37
Detachment of Device or Device Component
37
37
Material Integrity Problem
37
37
Suction Problem
33
33
Unraveled Material
33
33
Difficult to Remove
28
28
Crack
26
26
No Apparent Adverse Event
25
25
Obstruction of Flow
25
25
Contamination /Decontamination Problem
21
21
Deformation Due to Compressive Stress
19
19
Material Split, Cut or Torn
18
18
Entrapment of Device
16
16
Suction Failure
16
16
Material Twisted/Bent
14
14
Component Misassembled
13
13
Material Puncture/Hole
13
13
Restricted Flow rate
12
12
Material Deformation
11
11
Use of Device Problem
10
10
Device Damaged Prior to Use
10
10
Physical Resistance/Sticking
10
10
Improper or Incorrect Procedure or Method
9
9
Appropriate Term/Code Not Available
9
9
Particulates
9
9
Fitting Problem
7
7
Migration or Expulsion of Device
7
7
Difficult to Insert
7
7
Failure to Advance
6
6
Tear, Rip or Hole in Device Packaging
6
6
Loose or Intermittent Connection
5
5
Device Dislodged or Dislocated
5
5
Component Missing
5
5
Material Frayed
4
4
Loss of or Failure to Bond
4
4
Insufficient Information
4
4
Difficult to Fold, Unfold or Collapse
4
4
Difficult to Flush
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1847
1847
No Consequences Or Impact To Patient
213
213
Foreign Body In Patient
196
196
No Known Impact Or Consequence To Patient
79
79
Insufficient Information
71
71
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
58
58
No Patient Involvement
44
44
Unspecified Infection
38
38
No Code Available
25
25
Hematoma
22
22
Hemorrhage/Bleeding
20
20
Device Embedded In Tissue or Plaque
19
19
Pneumothorax
19
19
Failure to Anastomose
18
18
Not Applicable
18
18
Seroma
17
17
Pain
16
16
Fistula
14
14
Post Operative Wound Infection
12
12
Endophthalmitis
9
9
Patient Problem/Medical Problem
9
9
Wound Dehiscence
9
9
Bacterial Infection
8
8
Toxic Anterior Segment Syndrome (TASS)
8
8
Failure of Implant
8
8
Necrosis
7
7
Inflammation
7
7
Abscess
7
7
Pleural Effusion
6
6
Obstruction/Occlusion
6
6
Sepsis
5
5
Cardiac Tamponade
5
5
Capsular Bag Tear
5
5
Injury
5
5
Pneumonia
5
5
Low Blood Pressure/ Hypotension
4
4
No Information
4
4
Atrial Fibrillation
4
4
Impaired Healing
4
4
Hypoxia
4
4
Unspecified Tissue Injury
4
4
Uveitis
4
4
Fever
4
4
Abdominal Pain
3
3
Erythema
3
3
Conjunctivitis
3
3
Low Oxygen Saturation
3
3
Cellulitis
3
3
Blood Loss
3
3
Urinary Tract Infection
2
2
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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