Smart CoilRecalls & reported problems across all models

Penumbra, Inc. · 98 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2,616
Deaths reported: 2
Injuries reported: 151
Recalls: 0

We found 98 models of Smart Coil by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 2,616 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2015 and Mar 6, 2026 — classified as 2 deaths, 151 injuries, 2,463 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (1,466 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Last 36 months. The most recent month may be incomplete.

Most reported Smart Coil problems

Device problems

Failure to Advance1,466
Physical Resistance/Sticking692
Physical Resistance325
Separation Failure228
Difficult or Delayed Separation190
Material Deformation105
Adverse Event Without Identified Device or Use Problem99
Premature Separation81

Patient problems

No Consequences Or Impact To Patient1,852
No Clinical Signs, Symptoms or Conditions821
No Patient Involvement61
Thrombus35
Ischemia19
Weakness17
Neurological Deficit/Dysfunction15
Infarction, Cerebral13

Smart Coil models

98 models, most reported first. Each model has its own page with its reports, recalls and device details.

Smart Coil 400SMTHXSFT0208
DEVICE, NEUROVASCULAR EMBOLIZATION
165 reports
Smart Coil 400SMTHXSFT0102
DEVICE, NEUROVASCULAR EMBOLIZATION
1 death115 reports
Smart Coil 400SMTHXSFT0204
DEVICE, NEUROVASCULAR EMBOLIZATION
95 reports
Smart Coil 400SMTHXSFT0103
DEVICE, NEUROVASCULAR EMBOLIZATION
94 reports
Smart Coil 400SMTXSFT0103
DEVICE, NEUROVASCULAR EMBOLIZATION
84 reports
Smart Coil 400SMTXSFT0306
DEVICE, NEUROVASCULAR EMBOLIZATION
77 reports
Smart Coil 400SMTXSFT0308
DEVICE, NEUROVASCULAR EMBOLIZATION
75 reports
Smart Coil 400SMTXSFT0204
DEVICE, NEUROVASCULAR EMBOLIZATION
69 reports
Smart Coil 400SMTHXSFT1H03
DEVICE, NEUROVASCULAR EMBOLIZATION
66 reports
Smart Coil 400SMTHXSFT2H06
DEVICE, NEUROVASCULAR EMBOLIZATION
60 reports
Smart Coil 400SMTXSFT0208
DEVICE, NEUROVASCULAR EMBOLIZATION
59 reports
Smart Coil 400SMTXSFT0102
DEVICE, NEUROVASCULAR EMBOLIZATION
58 reports
Smart Coil 400SMTHXSFT1H02
DEVICE, NEUROVASCULAR EMBOLIZATION
58 reports
Smart Coil 400SMTXSFT0410
DEVICE, NEUROVASCULAR EMBOLIZATION
56 reports
Smart Coil 400SMTXSFT0206
DEVICE, NEUROVASCULAR EMBOLIZATION
52 reports
Smart Coil 400SMTSFT0515
DEVICE, NEUROVASCULAR EMBOLIZATION
51 reports
Smart Coil 400SMTHXSFT0306
DEVICE, NEUROVASCULAR EMBOLIZATION
50 reports
Smart Coil 400SMTXSFT1H03
DEVICE, NEUROVASCULAR EMBOLIZATION
47 reports
Smart Coil 400SMTXSFT0304
DEVICE, NEUROVASCULAR EMBOLIZATION
47 reports
Smart Coil 400SMTHXSFT0206
DEVICE, NEUROVASCULAR EMBOLIZATION
46 reports
Smart Coil 400SMTSFT0510
DEVICE, NEUROVASCULAR EMBOLIZATION
44 reports
Smart Coil 400SMTSFT0408
DEVICE, NEUROVASCULAR EMBOLIZATION
43 reports
Smart Coil 400SMTHXSFT0203
DEVICE, NEUROVASCULAR EMBOLIZATION
43 reports
Smart Coil 400SMTHXSFT0308
DEVICE, NEUROVASCULAR EMBOLIZATION
42 reports
Smart Coil 400SMTSFT0308
DEVICE, NEUROVASCULAR EMBOLIZATION
41 reports
Smart Coil 400SMTXSFT2H04
DEVICE, NEUROVASCULAR EMBOLIZATION
38 reports
Smart Coil 400SMTSFT0410
DEVICE, NEUROVASCULAR EMBOLIZATION
36 reports
Smart Coil 400SMTHXSFT0202
DEVICE, NEUROVASCULAR EMBOLIZATION
36 reports
Smart Coil 400SMTSFT0615
DEVICE, NEUROVASCULAR EMBOLIZATION
34 reports
Smart Coil 400SMTHXSFT1H04
DEVICE, NEUROVASCULAR EMBOLIZATION
32 reports
Smart Coil 400SMTXSFT0104
DEVICE, NEUROVASCULAR EMBOLIZATION
29 reports
Smart Coil 400SMTHXSFT2H04
DEVICE, NEUROVASCULAR EMBOLIZATION
29 reports
Smart Coil 400SMTSFT0306
DEVICE, NEUROVASCULAR EMBOLIZATION
28 reports
Smart Coil 400SMTSFT0820
DEVICE, NEUROVASCULAR EMBOLIZATION
27 reports
Smart Coil 400SMTXSFT0406
DEVICE, NEUROVASCULAR EMBOLIZATION
27 reports
Smart Coil 400SMTXSFT0202
DEVICE, NEUROVASCULAR EMBOLIZATION
25 reports
Smart Coil 400SMTXSFT0408
DEVICE, NEUROVASCULAR EMBOLIZATION
25 reports
Smart Coil 400SMTXSFT1H02
DEVICE, NEUROVASCULAR EMBOLIZATION
24 reports
Smart Coil 400SMTXSFT0203
DEVICE, NEUROVASCULAR EMBOLIZATION
24 reports
Smart Coil 400SMTXSFT2H06
DEVICE, NEUROVASCULAR EMBOLIZATION
24 reports
Smart Coil 400SMTHXSFT0101
DEVICE, NEUROVASCULAR EMBOLIZATION
21 reports
Smart Coil 400SMTXSFT3H08
DEVICE, NEUROVASCULAR EMBOLIZATION
21 reports
Smart Coil 400SMTHXSFT0408
DEVICE, NEUROVASCULAR EMBOLIZATION
20 reports
Smart Coil 400SMTHXSFT0510
DEVICE, NEUROVASCULAR EMBOLIZATION
19 reports
Smart Coil 400SMTXSFT011H
DEVICE, NEUROVASCULAR EMBOLIZATION
18 reports
Smart Coil 400SMTXSFT3H06
DEVICE, NEUROVASCULAR EMBOLIZATION
18 reports
Smart Coil 400SMTSFT0715
DEVICE, NEUROVASCULAR EMBOLIZATION
17 reports
Smart Coil 400SMTSFT0406
DEVICE, NEUROVASCULAR EMBOLIZATION
17 reports
Smart Coil 400SMTXSFT1H04
DEVICE, NEUROVASCULAR EMBOLIZATION
17 reports
Smart Coil 400SMTSFT0304
DEVICE, NEUROVASCULAR EMBOLIZATION
16 reports
Smart Coil 400SMTHXSFT0410
DEVICE, NEUROVASCULAR EMBOLIZATION
16 reports
Smart Coil 400SMTSTD1260
DEVICE, NEUROVASCULAR EMBOLIZATION
15 reports
Smart Coil 400SMTSTD0830
DEVICE, NEUROVASCULAR EMBOLIZATION
15 reports
Smart Coil 400SMTSTD0725
DEVICE, NEUROVASCULAR EMBOLIZATION
15 reports
Smart Coil 400SMTSTD0620
DEVICE, NEUROVASCULAR EMBOLIZATION
15 reports
Smart Coil 400SMTSTD0515
DEVICE, NEUROVASCULAR EMBOLIZATION
14 reports
Smart Coil 400SMTSFT0610
DEVICE, NEUROVASCULAR EMBOLIZATION
14 reports
Smart Coil 400SMTXSFT0101
DEVICE, NEUROVASCULAR EMBOLIZATION
14 reports
Smart Coil 400SMTSFT3H08
DEVICE, NEUROVASCULAR EMBOLIZATION
14 reports
Smart Coil 400SMTSFT4H10
DEVICE, NEUROVASCULAR EMBOLIZATION
13 reports
Smart Coil 400SMTSTD1460
DEVICE, NEUROVASCULAR EMBOLIZATION
11 reports
Smart Coil 400SMTSTD1045
DEVICE, NEUROVASCULAR EMBOLIZATION
11 reports
Smart Coil 400SMTSFT0203
DEVICE, NEUROVASCULAR EMBOLIZATION
11 reports
Smart Coil 400SMTXSFT2H08
DEVICE, NEUROVASCULAR EMBOLIZATION
11 reports
Smart Coil 400SMTSFT0506
DEVICE, NEUROVASCULAR EMBOLIZATION
10 reports
Smart Coil 400SMTSTD1660
DEVICE, NEUROVASCULAR EMBOLIZATION
9 reports
Smart Coil 400SMTXSFT2H03
DEVICE, NEUROVASCULAR EMBOLIZATION
9 reports
Smart Coil 400SMTHXSFT0406
DEVICE, NEUROVASCULAR EMBOLIZATION
9 reports
Smart Coil 400SMTHXSFT2H08
DEVICE, NEUROVASCULAR EMBOLIZATION
9 reports
Smart Coil 400SMTSFT3H06
DEVICE, NEUROVASCULAR EMBOLIZATION
9 reports
Smart Coil 400SMTXSFT4H12
DEVICE, NEUROVASCULAR EMBOLIZATION
9 reports
Smart Coil 400SMTSTD0408
DEVICE, NEUROVASCULAR EMBOLIZATION
8 reports
Smart Coil 400SMTHXSFT0304
DEVICE, NEUROVASCULAR EMBOLIZATION
8 reports
Smart Coil 400SMTHXSFT0415
DEVICE, NEUROVASCULAR EMBOLIZATION
8 reports
Smart Coil 400SMTSTD0615
DEVICE, NEUROVASCULAR EMBOLIZATION
7 reports
Smart Coil 400SMTSFT0930
DEVICE, NEUROVASCULAR EMBOLIZATION
7 reports
Smart Coil 400SMTSTD0930
DEVICE, NEUROVASCULAR EMBOLIZATION
6 reports
Smart Coil 400SMTXSFT0205
DEVICE, NEUROVASCULAR EMBOLIZATION
6 reports
Smart Coil 400SMTHXSFT1H01
DEVICE, NEUROVASCULAR EMBOLIZATION
6 reports
Smart Coil 400SMTSTD1360
DEVICE, NEUROVASCULAR EMBOLIZATION
5 reports
Smart Coil 400SMTSTD1860
DEVICE, NEUROVASCULAR EMBOLIZATION
5 reports
Smart Coil 400SMTSTD0820
DEVICE, NEUROVASCULAR EMBOLIZATION
5 reports
Smart Coil 400SMTSTD0715
DEVICE, NEUROVASCULAR EMBOLIZATION
4 reports
Smart Coil 400SMTSTD0510
DEVICE, NEUROVASCULAR EMBOLIZATION
4 reports
Smart Coil 400SMTSTD1545
DEVICE, NEUROVASCULAR EMBOLIZATION
3 reports
Smart Coil 400SMTSTD1345
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTSTD1445
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTSTD1030
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTSTD1145
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTSTD1160
DEVICE, NEUROVASCULAR EMBOLIZATION
1 death2 reports
Smart Coil 400SMTSTD1245
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTSTD0410
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTSFT0720
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTHXSFT0420
DEVICE, NEUROVASCULAR EMBOLIZATION
2 reports
Smart Coil 400SMTSTD1560
DEVICE, NEUROVASCULAR EMBOLIZATION
1 report
Smart Coil 400SMTSTD1135
DEVICE, NEUROVASCULAR EMBOLIZATION
1 report
Smart Coil 400SMTSFT1030
DEVICE, NEUROVASCULAR EMBOLIZATION
1 report
Smart Coil 400SMTHXSFT4H15
DEVICE, NEUROVASCULAR EMBOLIZATION
1 report

Recent Smart Coil adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionMar 6, 2026Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A RECOILING EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) USING A SMART COIL (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AN INTERMEDIATE CATHETER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE TARGET VESSEL WAS PREVIOUSLY COILED USING STENT SUPPORT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN MADE ADDITIONAL ATTEMPTS TO DETACH THE SMART COIL USING A SECOND HANDLE AND VIA MANUAL DETACHMENT; HOWEVER, THE SMART COIL WOULD STILL NOT DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. WHILE REMOVING THE SMART COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530948 ↗
MalfunctionAug 27, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A SMART COIL INTO THE TARGET LOCATION USING THE HANDLE. AFTER ADVANCING ANOTHER SMART COIL INTO THE TARGET VESSEL, THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN REMOVED AND REINSERTED THE PUSHER ASSEMBLY OF THE SMART COIL INTO THE HANDLE AND MADE ANOTHER ATTEMPT TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL STILL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL STILL DID NOT DETACH. WHILE ATTEMPTING TO RETRACT THE SMART COIL AND REMOVE IT FROM THE PATIENT, THE COIL UNINTENTIONALLY DETACHED. HOWEVER, THE SMART COIL WAS ABLE TO BE REMOVED FROM THE PATIENT MANUALLY. THE PROCEDURE WAS COMPLETED BY USING A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22908935 ↗
MalfunctionAug 21, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOMM) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET LOCATION AND MANUALLY DETACHED THE SMART COIL INTO THE TARGET LOCATION. WHILE RETRACTING THE SMART COIL PUSHER ASSEMBLY, THE PHYSICIAN FELT SOMETHING HUNG ON TO THE SMART COIL PUSHER ASSEMBLY AND THE SMART COIL WAS SLIGHTLY PULLED OUT OF THE ANEURYSM BEFORE FULLY DETACHING. IT WAS NOTED THAT THE LAST IMAGING REVEALED THAT THE TAIL END OF THE EMBOLIZATION COIL WAS IN THE PARENT VESSEL AND WAS NOT INSIDE THE MICROCATHETER. THE PHYSICIAN THEN USED THE SMART COIL PUSHER ASSEMBLY AND THE MICROCATHETER TO PUSH THE SMART COIL BACK INTO THE TARGET LOCATION, BUT A SMALL PART OF THE SMART COIL WAS STILL LEFT FREE FLOWING IN THE PARENT VESSEL. THE PHYSICIAN DECIDED TO LEAVE THE SMART COIL IN THE PCOMM AS THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT.
Patient problems: Foreign Body In Patient
MAUDE report 22865221 ↗
MalfunctionApr 23, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PENILE ARTERY USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS INTO THE TARGET VESSEL USING THE HANDLE. AFTER ADVANCING THE THIRD SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE COIL WOULD NOT DETACH. THEREFORE, THE HANDLE WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO USE A SECOND HANDLE TO DETACH THE SAME SMART COIL; HOWEVER, THE COIL STILL DID NOT DETACH. WHILE ATTEMPTING TO MANUALLY DETACH THE SMART COIL, THE COIL WAS INADVERTENTLY PULLED BACK INTO THE MICROCATHETER AND DETACHED WITHIN THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN THEN USED THE SMART COIL PUSHER ASSEMBLY TO SUCCESSFULLY IMPLANT THE COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS, THE SECOND HANDLE, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896096 ↗
MalfunctionSep 6, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO DETACH THE SMART COIL USING A SECOND HANDLE; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITH HALF OF THE SMART COIL STILL IN THE ANEURYSM AND THE OTHER HALF IN THE MCA. THE PHYSICIAN THEN USED THE MICROCATHETER TO SUCCESSFULLY PUSH THE DETACHED SMART COIL BACK INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163650 ↗
MalfunctionApr 19, 2024Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION AND REPORTED THAT IT WAS NOT TAKING ITS INTENDED SHAPE. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ADVANCING ANOTHER SMART COIL OF THE SAME SIZE THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE SMART COIL WAS UNRAVELED WITHIN THE MICROCATHETER AND HAD BECOME STUCK. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL AND NOTICED THAT IT HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED FROM THE PATIENT. AT THIS POINT, THE PHYSICIAN LACKED SMALLER COIL OPTIONS TO BE ABLE TO PROCEED WITH THE PROCEDURE AND THEREFORE, THE PROCEDURE WAS SUSPENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19148901 ↗
MalfunctionOct 13, 2023Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL USING THE MICROCATHETER INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL THREE TIMES WITHOUT SUCCESS. WHILE ATTEMPTING TO RETRACT THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN USED THE GUIDEWIRE TO PUSH THE SMART COIL INTO THE VESSEL AND FLUSHED IT. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL MANUALLY BUT WAS UNSUCCESSFUL. THE SMART COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17932595 ↗
InjurySep 29, 2023Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD STILL NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A MICROWAVE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET LOCATION SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A FOURTH SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. WHILE RETRACTING
Patient problems: Thrombosis/Thrombus
MAUDE report 17844127 ↗
InjurySep 29, 2023Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD STILL NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A MICROWAVE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET LOCATION SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A FOURTH SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. WHILE RETRACTING
Patient problems: Thrombosis/Thrombus
MAUDE report 17844126 ↗
InjurySep 29, 2023Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD STILL NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A MICROWAVE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET LOCATION SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A FOURTH SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. WHILE RETRACTING
Patient problems: Thrombosis/Thrombus
MAUDE report 17844125 ↗
MalfunctionAug 2, 2023Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE TWO TIMES; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED THE DETACHED SMART COIL''S PUSHER WIRE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17446153 ↗
MalfunctionJul 27, 2023Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COIL), SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE SEVERAL TIMES; HOWEVER, THE SMART COIL FAILED TO DETACH. THEN THE PHYSICIAN USED A SECOND HANDLE WITHOUT SUCCESS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED THE DETACHED SMART COIL''S PUSHER WIRE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A SECOND SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE SECOND HANDLE; HOWEVER, THE SMART COIL WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17402770 ↗
MalfunctionJul 6, 2023Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THEN ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER MULTIPLE FAILED ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO NEW SMART COILS, A NEW HANDLE, AND FOUR NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17275036 ↗
MalfunctionJun 21, 2023Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND TWO NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING A MICROCATHETER, THEN ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE SMART COIL HAD SUGGESTED THAT THE SMART COIL WAS DETACHED INTO THE TARGET VESSEL. HOWEVER, WHILE REMOVING THE PUSHER ASSEMBLY AND CATHETER, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED OUTSIDE OF THE TARGET VESSEL. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER; HOWEVER, THE MICROCATHETER KICKED OUT OF THE TARGET VESSEL. SUBSEQUENTLY, THE SMART COIL MOVED A FEW CENTIMETERS OUTSIDE OF THE TARGET VESSEL. THE MICROCATHETER WAS THEN REMOVED, AND THE PHYSICIAN SUCCESSFULLY REMOVED THE SMART COIL USING THE NON-PENUMBRA CATHETER AND A SNARE DEVICE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17178112 ↗
MalfunctionJun 5, 2023Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL WOULD NOT DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE COIL BUT THE SMART COIL STILL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN PUSHED THE DETACHED SMART COIL INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17056628 ↗

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Sources and updates

Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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