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TPLC
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show TPLC since
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2020
2021
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2024
2025
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Device
device, hemostasis, vascular
Product Code
MGB
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
10
17
11
18
22
11
MDR Year
MDR Reports
MDR Events
2020
5927
5927
2021
7586
7586
2022
9457
9466
2023
13529
13529
2024
13761
13761
2025
5750
5750
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cycle
29787
29787
Material Separation
6066
6066
Improper or Incorrect Procedure or Method
2184
2184
Malposition of Device
2124
2124
Insufficient Information
1684
1684
Off-Label Use
1568
1568
Adverse Event Without Identified Device or Use Problem
1543
1543
Patient Device Interaction Problem
1427
1427
Difficult to Open or Close
1378
1378
Activation, Positioning or Separation Problem
1311
1311
Entrapment of Device
1308
1308
Difficult to Remove
1158
1158
Obstruction of Flow
1050
1050
Failure to Fire
864
864
Decrease in Pressure
769
769
Mechanical Jam
759
759
Difficult to Insert
746
746
Physical Resistance/Sticking
710
710
Activation Failure
675
675
Defective Component
622
622
Material Rupture
593
593
Break
561
561
Failure to Advance
552
552
Material Deformation
509
509
Premature Activation
500
500
Difficult to Advance
489
489
Product Quality Problem
412
412
Detachment of Device or Device Component
330
330
Deformation Due to Compressive Stress
295
295
Misconnection
290
290
Retraction Problem
282
282
Activation Problem
276
276
Unintended System Motion
246
246
Positioning Failure
230
230
Migration
230
239
Loosening of Implant Not Related to Bone-Ingrowth
215
215
Therapy Delivered to Incorrect Body Area
204
204
Failure to Seal
177
177
Positioning Problem
147
147
Material Split, Cut or Torn
145
145
Device Damaged by Another Device
140
140
Difficult or Delayed Activation
130
130
Component Missing
125
125
Noise, Audible
108
108
Separation Failure
99
99
Failure to Cut
93
93
Material Puncture/Hole
92
92
Difficult or Delayed Positioning
82
82
Unintended Movement
81
81
Therapeutic or Diagnostic Output Failure
79
79
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
45059
45068
No Consequences Or Impact To Patient
4568
4568
Hemorrhage/Bleeding
1402
1402
Hematoma
971
980
Obstruction/Occlusion
916
916
Unspecified Tissue Injury
707
707
Insufficient Information
702
702
Pseudoaneurysm
516
525
Vascular Dissection
423
423
Foreign Body In Patient
418
418
Pain
391
391
Blood Loss
262
262
Extravasation
246
246
Thrombosis/Thrombus
228
228
Unspecified Infection
215
215
Tissue Damage
189
189
Stenosis
151
151
Occlusion
144
144
Ischemia
131
131
Swelling/ Edema
130
130
Perforation of Vessels
123
123
Low Blood Pressure/ Hypotension
99
99
Diminished Pulse Pressure
78
78
Local Reaction
69
69
Retroperitoneal Hemorrhage
65
65
Unspecified Vascular Problem
63
63
Intimal Dissection
61
61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
61
70
Failure of Implant
59
59
Thrombosis
59
59
Embolism/Embolus
54
54
Fistula
52
52
Device Embedded In Tissue or Plaque
49
49
Numbness
44
44
No Information
43
43
No Patient Involvement
42
42
No Known Impact Or Consequence To Patient
42
42
Death
42
42
Laceration(s)
42
51
Anemia
42
42
Inflammation
41
41
Stroke/CVA
38
38
Perforation
36
36
Bruise/Contusion
34
34
Shock
29
29
No Code Available
23
23
Aneurysm
22
22
Renal Failure
22
22
Nerve Damage
21
21
Cardiac Arrest
20
20
Recalls
Manufacturer
Recall Class
Date Posted
1
Cordis US Corp
II
Jan-05-2024
2
TELEFLEX LLC
II
May-18-2023
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