Cordis S.M.A.R.T. Control Vascular Stent SystemRecalls & reported problems across all models
Cordis US Corp. · 30 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Cordis S.M.A.R.T. Control Vascular Stent System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 99
- Deaths reported
- 7
- Injuries reported
- 35
- Recalls
- 2
We found 30 models of Cordis S.M.A.R.T. Control Vascular Stent System by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2016 and Aug 4, 2023 — classified as 7 deaths, 35 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (41 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Cordis S.M.A.R.T. Control Vascular Stent System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 4, 2025Class IIOpen, Classified
product mix-up; Vascular stent labeled as one size but contains a different size.
Z-1511-2025 · Root cause: Employee error · Recall details · FDA record ↗
- Mar 4, 2025Class IIOpen, Classified
product mix-up; Vascular stent labeled as one size but contains a different size.
Z-1510-2025 · Root cause: Employee error · Recall details · FDA record ↗
Most reported Cordis S.M.A.R.T. Control Vascular Stent System problems
Device problems
- Difficult or Delayed Positioning41
- Adverse Event Without Identified Device or Use Problem20
- Material Frayed14
- Occlusion Within Device7
- Material Split, Cut or Torn6
- Detachment of Device or Device Component5
- Difficult to Remove3
- Fracture3
Patient problems
- No Consequences Or Impact To Patient46
- No Clinical Signs, Symptoms or Conditions22
- Reocclusion14
- Occlusion6
- Stenosis4
- Vascular System (Circulation), Impaired4
- Death3
- Claudication2
Cordis S.M.A.R.T. Control Vascular Stent System models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1 recall3 reports
- 1 recall0 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C08040SLSTENT, SUPERFICIAL FEMORAL ARTERY7 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C08060MLSTENT, SUPERFICIAL FEMORAL ARTERY7 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C08100SLSTENT, SUPERFICIAL FEMORAL ARTERY2 deaths7 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C07040MLSTENT, SUPERFICIAL FEMORAL ARTERY6 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09040SLSTENT, SUPERFICIAL FEMORAL ARTERY1 death6 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C06040MLSTENT, SUPERFICIAL FEMORAL ARTERY1 death5 reports
- 5 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C06100SLSTENT, SUPERFICIAL FEMORAL ARTERY5 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C08060SLSTENT, SUPERFICIAL FEMORAL ARTERY1 death5 reports
- 5 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C10060SLSTENT, SUPERFICIAL FEMORAL ARTERY5 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C10030SLSTENT, SUPERFICIAL FEMORAL ARTERY4 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C07100MLSTENT, SUPERFICIAL FEMORAL ARTERY3 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C08030SLSTENT, SUPERFICIAL FEMORAL ARTERY3 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C10040SLSTENT, SUPERFICIAL FEMORAL ARTERY3 reports
- 2 reports
- 2 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C07060SLSTENT, SUPERFICIAL FEMORAL ARTERY2 reports
- 2 reports
- 1 death2 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C08080MLSTENT, SUPERFICIAL FEMORAL ARTERY1 death2 reports
- 2 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C06020MLSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- Cordis S.M.A.R.T. Control Vascular Stent System C06040SLSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- Cordis S.M.A.R.T. Control Vascular Stent System C06060SLSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- Cordis S.M.A.R.T. Control Vascular Stent System C06080SLSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- Cordis S.M.A.R.T. Control Vascular Stent System C07100SLSTENT, SUPERFICIAL FEMORAL ARTERY1 report
- Cordis S.M.A.R.T. Control Vascular Stent System C08080SLSTENT, SUPERFICIAL FEMORAL ARTERY1 report
Recent Cordis S.M.A.R.T. Control Vascular Stent System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2023Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration
AS REPORTED BY THE PHYSICIAN, THE 9X40 SMART CONTROL ILIAC STENT SEEMED TO JUMP FORWARD MORE THAN WAS NORMALLY EXPECTED. THE STENT MIGRATED APPROXIMATELY 3-4 CM. THE STENT WAS LEFT IN PLACE IN THE PATIENT. ADDITIONAL STENTS WERE NOT NEEDED TO COMPLETE THE PROCEDURE; THE SURGEON STOPPED FURTHER INTERVENTIONS AFTER STENT FAILURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FILED AND STORED AS PER LABELING. THE INTENDED PROCEDURE WAS REPORTED TO BE AN ANGIOGRAM, ANGIOPLASTY WITH STENT PLACEMENT. THERE WAS NO SIGNIFICANT CALCIFICATION OR TORTUOSITY NOTED WITH SEVENTY PERCENT (70%) STENOSIS AND THIRTY PERCENT (30%) POST-ANGIOPLASTY. THE AREA WAS PREDILATED PRIOR TO STENT IMPLANTATION USING A NON-CORDIS BALLOON. THE DEVICE WAS HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE TRAY. THE DIAMETER OF THE UNCONSTRAINED STENT WAS SIZED 1-2 MM LARGER THAN THE TARGET AREA. THERE WAS NO RESISTANCE/FRICTION DURING INSERTION OF THE DEVICE. TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17460785 ↗InjuryJul 25, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, AN ATTEMPT WAS MADE TO IMPLANT A 9X40 SMART CONTROL ILIAC STENT AT THE STENOSIS OF THE COMMON ILIAC ARTERY USING AN IPSILATERAL RETROGRADE APPROACH; HOWEVER, THE STENT JUMPED AND MOVED CENTRAL SIDE FROM THE DESIRED LOCATION. THE COMPLAINT DEVICE DID NOT COVER THE LESION; THEREFORE, ADDITIONAL STENT(S) WERE ADDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE ILIAC ARTERY DILATATION. THERE WAS MODERATE LESION CALCIFICATION AND TORTUOSITY WITH SEVENTY-FIVE PER CENT (75%) STENOSIS. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU); THERE WERE NO DIFFICULTIES EXPERIENCED IN PREPPING THE DEVICE. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS NOT CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. NOTHING UNUSUAL WAS NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE TRAY. THE DIAMETER OF THE UNCONSTRAINED STENT WAS SIZED 1-2 MM LARGER THAN THE TARGET AREA. THERE WAS NO RESISTANCE/FRICTION DURING INSERTION OF THE DEVICE. THE STENT DELIVERY SYSTEM DID NOT PA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17387978 ↗MalfunctionMay 3, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
AS REPORTED, THE SMART CONTROL STENT WAS ATTEMPTED TO BE DELIVERED TO THE LESION, BUT THE DISTAL TIP WAS FRAYED. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER, BIGGER SIZED SMART STENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS AN ILIAC CASE. PRE-DILATION WAS PERFORMED. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH WHEN THE DEVICE WAS REMOVED FROM THE TRAY. A NON-CORDIS SHEATH WAS USED FOR THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16860738 ↗MalfunctionMar 9, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, A SMART CONTROL ILIAC 7X100 SELF-EXPANDING STENT DID NOT DEPLOY PROPERLY. THE PHYSICIAN PULLED THE PIN AND PARTIALLY DEPLOYED THE STENT USING THE THUMB WHEEL. AFTER THE STENT STARTED TO OPPOSE THE VESSEL WALL THE PHYSICIAN CONVERTED TO THE SLIDE BUT THE STENT DID NOT DEPLOY SMOOTHLY BUT FOLDED IN ON ITSELF AND THEN CONTINUED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS REPORTED TO BE A RIGHT LEG ANGIOGRAM; RECANALIZATION OF RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS THE RIGHT SFA. LESION CHARACTERISTICS INCLUDED MODERATE LESION CALCIFICATION WITH NO VESSEL TORTUOSITY AND EIGHTY PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE PREPPED PER THE IFU WITHOUT DIFFICULTY. THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH WHEN REMOV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16519268 ↗DeathMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY GORE JAPAN, A PATIENT EXPIRED AFTER AN ON-SITE OPERATION. AN 8MM X 100MM SMART STENT (SES) WAS USED TO TREAT A LESION IN THE RIGHT EXTERNAL ILIAC ARTERY. POST-DILATATION WITH AN UNKNOWN BALLOON WAS DONE, RUPTURING A BLOOD VESSEL AND BLEEDING OCCURRED. THE VESSEL RUPTURE OCCURRED WHILE THE UNKNOWN BALLOON WAS IN THE STENT DURING POST-DILATATION. FOR HEMOSTASIS, NON-CORDIS STENT GRAFTS WERE DEPLOYED. A NON-CORDIS BALLOON EXPANDABLE STENT GRAFT WAS DEPLOYED ON THE CENTRAL SIDE, AND A SECOND NON-CORDIS STENT GRAFT WAS DEPLOYED ON THE PERIPHERAL SIDE. HEMOSTASIS WAS ACHIEVED AND THE PATIENT¿S VITAL SIGNS WERE STABLE, SO THE PROCEDURE WAS TERMINATED. APPROXIMATELY ONE DAY POST PROCEDURE, THE PATIENT HAD A SUDDEN CHANGE IN CONDITION REQUIRING RE-OPERATION. RE-BLEEDING OCCURRED, THE CAUSE OF WHICH WAS A SUSPECTED TYPE 2 ENDOLEAK. TWO UNKNOWN STENT GRAFTS AND THREE UNKNOWN BALLOON DILATATION STENT GRAFTS WERE IMPLANTED FROM THE AORTA TO THE BILATERAL ILIAC ARTERIES USING COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) TECHNIQUE TO OCCLUDE THE LUMBAR ARTERY AND CONTRALATERAL INTERNAL ILIAC ARTERY THAT MAY BE COMMUNICATING NEAR THE BLEEDING SITE. AFTER CONFIRM
Patient problems: Rupture
MAUDE report 16471139 ↗MalfunctionFeb 9, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, THE 8X40 SMART CONTROL STENT WAS INSERTED INTO THE SHEATH TO BE USED FOR THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS MADE WITH A 45CM NON-CORDIS GUIDING SHEATH. THE PHYSICIAN NOTICED THAT THE STENT WAS SLIGHTLY DEPLOYED FLARE FROM THE TIP WHEN THE COMPLAINT DEVICE CAME OUT OF THE SHEATH. IT WAS NOTED THAT APPROXIMATELY 5MM OF THE STENT WAS DEPLOYED. THE COMPLAINT DEVICE WAS REMOVED WITHOUT IMPLANT, BUT THE STENT STRUT GOT CAUGHT ON THE Y-CONNECTOR OF THE CONCOMITANT SHEATH. THE STENT WAS DEPLOYED OUTSIDE THE BODY IN SUCH A WAY THAT THE STENT WAS ENTANGLED WITH THE Y-CONNECTOR FROM THE DELIVERY SYSTEM. CONSIDERING THE POSSIBILITY THAT THE STENT WAS SLIGHTLY DEPLOYED DUE TO CALCIFICATION IN THE ILIAC, THE PHYSICIAN CHANGED TO AN IPSILATERAL APPROACH. THE SHEATH WAS REPLACED WITH A NEW 23CM NON-CORDIS SHEATH AND A SMART STENT (8*30) WAS USED FOR THE SUPERFICIAL FEMORAL ARTERY AND THE PROCEDURE COMPLETED. THE SECOND STENT WAS PLACED WITH AND WAS WELL EXPANDED AND IN GOOD POSITION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO LESION AT THE ILIAC ARTERY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16335127 ↗InjuryNov 21, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, AN ILIAC 7 X 40ML SMART CONTROL VASCULAR STENT JUMPED 2/3 OF THE LENGTH OF THE STENT UPON PLACEMENT INTO THE SUBCLAVIAN ARTERY. A SECOND 8MM X 30MM SMART STENT WAS THEN DEPLOYED TO ACT AS AN ANCHOR FOR THE INITIAL STENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE STENT WAS BEING PLACED IN THE LEFT SUBCLAVIAN VEIN AT THE ANASTOMOSIS OF THE "LEFT JUGULAR". THE PROXIMAL MARKER OF THE STENT WAS PLACED RIGHT AT THE JUGULAR VEIN AND THE DISTAL MARKER OF THE STENT WAS PLACED INTO THE "SUBCLAVIAN". UPON INITIATING DEPLOYMENT OF THE DEVICE, THE STENT JUMPED CENTRALLY INTO THE BRACHIOCEPHALIC VEIN LEAVING 1/3 OF THE STENT INTO THE SUBCLAVIAN ARTERY. POST- PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PREFORMED TO ENSURE THAT THE STENT DID NOT MOVE CENTRALLY. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED TO CONFIRM THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE TARGET LESION VESSEL DIAMETER WAS 5.5MM. A 6F CORDIS BRITE TIP SHEATH WAS USED. THE DIAMETER OF THE UNCONSTRAINED STEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15832619 ↗MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, THE TUNING DIAL ON A 10 X 40ML ILIAC SMART CONTROL VASCULAR STENT SYSTEM WAS UNABLE TO BE TURNED ALL THE WAY. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER DIFFERENT SIZED DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY. THE LESION WAS THE SUBCLAVIAN ARTERY WHICH WAS STENOSED. AN APPROACH WAS MADE FROM THE FEMORAL ARTERY. A 6FR 90CM NON-CORDIS SHEATH WAS USED. THE SMART CONTROL DEVICE WAS ATTEMPTED TO BE IMPLANTED. AFTER THE INCIDENT, THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT TO OBSERVE. THE OUTER SHEATH HAD BEEN RETRACTED UNTIL THE STENT WAS ABOUT TO COME OUT. THE TUNING DIAL HAD BEEN RETRACTED TOWARDS THE PROXIMAL PART FROM THE ORIGINAL POSITION. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: A SEPARATION ON THE INNER LUMEN AND A SEVERE KINK WERE OBSERVED ON THE RETURNED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510710 ↗DeathSep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, AN ENDOVASCULAR THERAPY (EVT) PROCEDURE WAS BEING PERFORMED TO TREAT A CHRONIC TOTALLY OCCLUDED (CTO) COMMON ILIAC ARTERY (CIA) LESION, AND A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. AN UNKNOWN GUIDEWIRE WAS INSERTED AND CROSSED THE CIA LESION, WHICH WAS FOLLOWED BY THE USE OF AN 8MM X 4CM 155CM SABERX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO PERFORM A BALLOON ANGIOPLASTY AT THE CIA LESION. THE SABERX PTA BALLOON CATHETER WAS THEN USED TO TREAT THE DISTAL SFA LESION. AN 8MM X 80MM S.M.A.R.T. CONTROL ILIAC SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS THEN INSERTED AND IMPLANTED IN THE CIA. AFTER IMPLANTATION OF THE SES, A PERFORATION OF THE CIA WAS CONFIRMED, AND AN ADDITIONAL ACCESS WAS MADE RETROGRADELY IN ORDER TO INSERT THE 8MM X 4CM SABERX PTA BALLOON CATHETER TO BE USED FOR HEMOSTASIS OF THE PERFORATED CIA. AFTER THE USE OF THE SABERX PTA BALLOON, TWO NON-CORDIS STENTS OF UNKNOWN SIZES WERE IMPLANTED. HEMOSTASIS WAS CONFIRMED AND THE PROCEDURE WAS COMPLETED. AFTER COMPLETION OF THE PROCEDURE, RE-BLEEDING FROM THE CIA LESION WAS CONFIRMED. THE PHYSICIAN TRIED TREATMENT, BUT THE PATIENT PASSED AWAY THE FOLLOWING DAY. BOTH DEVICES WERE DISCAR
Patient problems: Perforation of Vessels
MAUDE report 15479848 ↗InjuryJun 23, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, DURING TREATMENT OF A LESION IN THE RIGHT COMMON ILIAC ARTERY, A 10MM X 60MM 80CM S.M.A.R.T. CONTROL ILIAC SELF-EXPANDING STENT (SES) DELIVERY SYSTEM WAS DELIVERED TO THE AORTA OVER A 135CM NON-CORDIS GUIDEWIRE TO ADJUST THE IMPLANTATION POSITION. DURING THE ADJUSTMENT OF THE IMPLANTATION POSITION, THE INTERVENTIONAL PHYSICIAN WAS DISCUSSING THE IMPLANTATION POSITION WITH ANOTHER PHYSICIAN WHEN THE STENT WAS MISTAKENLY DEPLOYED AND IMPLANTED IN THE ABDOMINAL AORTA, EXTENDING FROM BELOW THE RENAL ARTERY TO JUST ABOVE THE COMMON ILIAC ARTERY (CIA) BIFURCATION. A 6F 21CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) THAT WAS INITIALLY USED FOR THE PROCEDURE WAS REPLACED WITH A 7F 43CM NON-CORDIS CSI AND AN UNKNOWN SNARING DEVICE WAS USED TO PULL THE STENT INTO THE 7F 43CM NON-CORDIS CSI AND REMOVE THE STENT SUCCESSFULLY. AS A RESULT, A NEW 10MM X 60MM 80CM S.M.A.R.T. CONTROL ILIAC SES DELIVERY SYSTEM WAS USED, AND THE STENT WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE AORTA. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE PRIOR TO USE. THE T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14792777 ↗InjuryJun 16, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, THE PHYSICIAN WENT TO START DEPLOYING THE SMART CONTROL 10X30 STENT, SLOWLY MOVING THE CONTROL WHEEL AND THE STENT JUMPED OFF THE RAIL AND DEPLOYED DISTAL TO WHERE THE TARGET LESION WAS. A SMART CONTROL 10X40 WAS USED TO COMPLETE THE CASE. NO HARM/INJURY WAS DONE TO THE PATIENT AND ANOTHER STENT HAD TO BE USED TO COVER THE LESION. THE STENT WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS ALSO NOTED THAT THERE WERE NO ISSUES WITH THE STENT. IT WAS NOTED THAT THERE WAS NO RESISTANCE DEPLOYING THE STENT AS THE STENT JUMPED OFF THE RAIL SYSTEM. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND WAS CLEARLY VISIBLE. NOTHING UNUSUAL WAS NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH AFTER REMOVAL FROM THE TRAY. A STOPCOCK WAS CONNECTED TO THE Y-CONNECTOR OF THE TUOHY BORST VALVE. THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE STOPCOCK OR THE SDS. A 6F SHEATH WAS USED FOR THE PROCEDURE. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION. THE LOCKING PIN WAS NOTED NOT TO BE REMOVED BEFORE ATT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14709575 ↗MalfunctionJun 3, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, AFTER THE SMART CONTROL WAS OPENED DURING THE PTA CASE, IT DEPLOYED ABOUT 2CM. IT WAS REPLACED WITH A NEW PRODUCT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS TO OBTAIN THE DEVICE AND ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596733 ↗InjuryMay 21, 2022Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration
AS REPORTED, THE PHYSICIAN WAS DEPLOYING THE SMART CONTROL ILIAC 10X30 STENT; HOWEVER, THE PHYSICIAN VISUALIZED THAT THE STRUTS AND RADIOPAQUE MARKERS OF THE STENT AND STOPPED TO CONFIRM POSITIONING UNDER FLUORO BEFORE DEPLOYMENT, HE WAS NOT MOVING THE ROLLER IN ANY DIRECTION, DURING THAT PAUSE IS WHEN THE PHYSICIAN NOTICED THE STENT HAD SLID/ JUMPED OFF THE DEPLOYMENT SYSTEM. ANOTHER STENT HAD TO BE PLACED AS THE STENT HAD MOVED TOO FAR FORWARD AND MISSED THE LANDING ZONE FOR THE LESION. THE ADDITIONAL STENT EXPAND FULLY WITH GOOD WALL APPOSITION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE TEMPERATURE EXPOSURE INDICATOR ON THE POUCH WAS CHECKED AND CONFIRMED THAT THE BLACK DOTTED PATTERN WITH A GREY BACKGROUND IS CLEARLY VISIBLE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE STENT WAS CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH AFTER REMOVED FROM THE PACKAGE. A STOPCOCK WAS CONNECTED TO THE Y-CONNECTOR OF THE TUOHY BORST VALVE. THERE WAS NO DIFFICULTY NOTED WHILE FLUSHING THE STOPCOCK OR WHILE FLUSHING THE SD
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14465473 ↗InjuryApr 28, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning
A 10X30 ILIAC SMART STENT WAS INSERTED FROM THE LEFT BRACHIAL REGION AND BEING DELIVERED, HOWEVER, THE STENT ¿ADVANCED AND FELL DOWN THE AORTA. AFTER THAT, THE DEVICE LOCKED TO THE PLAQUE IN THE MIDDLE OF THE DESCENDING AORTA. THE DOCTOR DECIDED TO FOLLOW UP WITHOUT ANY ADDITIONAL TREATMENT.¿ THIS WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE FROM THE BRACHIOCEPHALIC ARTERY. A 6F NON-CORDIS GUIDING SHEATH WAS INITIALLY INSERTED FROM THE LEFT BRACHIAL REGION. A 014 NON-CORDIS GUIDEWIRE CROSSED THE LESION AND A 5X30 NON-CORDIS BALLOON CATHETER WAS USED FOR PRE-DILATION. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14246559 ↗InjuryApr 23, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning
AS REPORTED, THE FIRST SMART CONTROL WAS IMPLANTED; HOWEVER, THE STENT ACCIDENTLY POPPED OUT AND IMPLANTED IN THE AORTA. ITS PROXIMAL EDGE BARELY HUNG OVER THE ENTRANCE AREA. A SECOND SMART CONTROL STENT WAS IMPLANTED AND ATTEMPTED TO STABILIZE IN THE SUBCLAVIAN ARTERY; HOWEVER, IT POPPED OUT AS WELL AND FELL TO THE VICINITY OF THE L2 OF THE AORTA WITH THE 8X60 STENT OVERLAPPING THE 8X30 STENT. THE AORTA DIAMETER WAS NARROW AND WAS TRAPPED IN CALCIFICATION AND WAS IMPLANTED ALONG THE AORTA. THE LESION WAS THE SUBCLAVIAN ARTERY WITH STENOSIS. A SMART 9X40 WERE IMPLANTED IN SUBCLAVIAN ARTERY LESION. A NON-CORDIS 5X40 BALLOON CATHETER WAS INFLATED AS POST-DILATION AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. A LEFT UPPER EXTREMITY APPROACH WAS MADE WITH A NON-CORDIS GUIDING CATHETER AND A NON-CORDIS WIRE CROSSED THE LESION. A SABER OTW (3-40) WAS INFLATED AS PRE-DILATION. THERE WAS AN ATTEMPT TO RETRIEVE THE PATIENT DUE TO THE PATIENT HAVING TEMPORARY LEG AND ABDOMINAL PAIN, BUT THE PATIENTS SYMPTOMS CALMED DOWN AND IT WAS DECIDED TO FOLLOW UP. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14191034 ↗
Other Cordis US Corp. products
All Cordis US Corp. devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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