WingspanRecalls & reported problems across all models

We found 12 models of Wingspan by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between May 23, 2016 and Jun 30, 2022 — classified as 7 deaths, 14 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (5 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

Most reported Wingspan problems

Wingspan models

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

• Wingspan M003WS0300150

  intracranial neurovascular stent
  7 reports
• Wingspan M003WS0350150

  intracranial neurovascular stent
  1 death4 reports
• Wingspan M003WS0300090

  intracranial neurovascular stent
  1 death3 reports
• Wingspan M003WS0350200

  intracranial neurovascular stent
  1 death3 reports
• Wingspan M003WS0400200

  intracranial neurovascular stent
  2 deaths3 reports
• Wingspan M003WS0450200

  intracranial neurovascular stent
  3 reports
• Wingspan M003WS0250150

  intracranial neurovascular stent
  2 reports
• Wingspan M003WS0250200

  intracranial neurovascular stent
  2 reports
• Wingspan M003WS0400150

  intracranial neurovascular stent
  1 death2 reports
• Wingspan M003WS0250090

  intracranial neurovascular stent
  1 report
• Wingspan M003WS0300200

  intracranial neurovascular stent
  1 report
• Wingspan M003WS0350090

  intracranial neurovascular stent
  1 death1 report

Recent Wingspan adverse event reports

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

• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE ANGIOPLASTY PROCEDURE FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE TREATMENT OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) PHYSICIAN USED THE SUBJECT STENT. HE TRIED TO INSERT THE DELIVERY CATHETER OF THE SUBJECT STENT AND WAS UNABLE TO ADVANCE IT INTO THE RHV. EVENTUALLY HE HAD TO USE AN OFF-LABEL STENT AS A MEDICAL INTERVENTION TO TREAT THE PATIENT. THE SURGERY WAS DELAYED FOR 20 MINUTES. PROCEDURE WAS NOT COMPLETED AS PHYSICIAN WANTED AND HAS TO USE A DIFFERENT STENT TO TREAT THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14868469 ↗
• MalfunctionMay 4, 2022Fracture; Premature Activation; Fracture; Premature Activation

  IT WAS REPORTED THAT DURING PROCEDURE AT M1 TREATMENT SITE, DURING DEPLOYMENT OF THE STENT (SUBJECT DEVICE), THE CUSTOMER FELT FRICTION WHILE TRYING TO PUSH THE HYPO TUBE INTO THE OUTER BODY OF THE DEVICE (RESISTANCE FELT WHEN TRYING TO DEPLOY THE STENT BY PULLING BACK THE OUTER BODY). AT ONE POINT, THE HUB OF THE OUTER BODY BROKE OFF THE CATHETER AND THE CATHETER APPEARED TO BE STRETCHED IN ONE SEGMENT OF THE CATHETER. THE CUSTOMER OPTED TO PULL THE DEVICE OUT BUT THAT INADVERTENTLY DEPLOYED THE STENT (SUBJECT DEVICE). HOWEVER, THE STENT (SUBJECT DEVICE) WAS DEPLOYED AT THE CORRECT POSITION THAT HE WANTED THE STENT TO DEPLOY. HE THEN CAREFULLY PULLED THE SYSTEM OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. AFTER PULLING THE SYSTEM OUT, WE NOTICED THE HUB OF THE OUTER BODY HAD BROKEN OFF AND NOTICED THE STRETCHING OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274949 ↗
• MalfunctionFeb 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN WAS ADVANCING THE SUBJECT WINGSPAN STENT SYSTEM OVER THE WIRE AND HE FOUND THE STABILIZER OF THE STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11304955 ↗
• MalfunctionNov 25, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF STENOTIC MCA (MIDDLE CEREBRAL ARTERY) WITH 80% STENOSIS AND CALCIFICATION AT THE LESION, AFTER ADVANCEMENT OF THE STENT DELIVERY SYSTEM (SUBJECT DEVICE)THROUGH TORTUOUS ANATOMY TO THE LESION, WHILE THE STENT DELIVERY SYSTEM WAS ATTEMPTING TO UNSHEATH THE STENT DURING DEPLOYMENT THE HYPOTUBE (STENT STABILIZER) SNAPPED OFF AT THE HUB OF MICROCATHETER OUTSIDE THE PATIENT VASCULATURE. WITH THE STABILIZER UNABLE TO DEPLOY THE STENT, THE SYSTEM WAS REMOVED FROM THE GUIDE CATHETER WITHOUT ANY ISSUES. ACCORDING TO PHYSICIAN VESSEL TORTUOSITY OF INTENDED AREA OF TREATMENT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901832 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT WAS DEPLOYED AT THE BASILAR ARTERY. PHYSICIAN NOTED THAT VESSEL PERFORATION HAD OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 10554357 ↗
• InjurySep 4, 2020Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS TRYING TO ADVANCE THE PUSHER MARKER TO THE PROXIMAL OF THE SUBJECT STENT. THE PUSHER MARKER WAS UNABLE TO REACH THE PROXIMAL SUBJECT STENT AND UNINTENTIONALLY DEPLOYED THE DISTAL END OF THE STENT. PHYSICIAN WAS FORCED TO DEPLOY THE SUBJECT STENT MORE DISTAL THAN INTENDED. THEREFORE, A SECOND STENT WAS USED TO TREAT THE LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10494991 ↗
• MalfunctionMar 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE PUSHER WIRE OF THE STENT DELIVERY SYSTEM (SUBJECT DEVICE) MAY HAVE BROKEN OR BENT INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9899220 ↗
• MalfunctionAug 14, 2019Break; Break

  IT WAS REPORTED THE STENT INNER BODY BROKE INSIDE THE PATIENT. THERE WAS NO CLINICAL CONSEQUENCE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893844 ↗
• MalfunctionAug 13, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THE STENT (SUBJECT DEVICE) PREMATURELY DEPLOYEDINSIDE THE PATIENT. THERE WAS NO WAS NO CLINICAL CONSEQUENCE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890714 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY AND STENTING WITH THE SUBJECT STENT OF A HIGH-GRADE LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT INTRACRANIAL STENOSIS WITH RECURRENT STROKES. APOST-PROCEDURE THE PATIENT CONDITION WAS STABLE. THREE HOURS POST-PROCEDURE, THE PATIENT DEVELOPED STROKE SYMPTOMS (EXPRESSIVE APHASIA, RUE (RIGHT UPPER EXTREMITY), RLE (RIGHT LOWER EXTREMITY), WEAKNESS, RIGHT FACIAL DROOP). COMPUTED TOMOGRAPHY (CT) HEAD WAS DONE WHICH DEMONSTRATED A LARGE LEFT FRONTAL LOBE INTRAPARENCHYMAL HEMORRHAGE AND A LEFT FRONT-TEMPORAL SUBARACHNOID HEMORRHAGE CAUSING MASS EFFECT AND A 5MM RIGHTWARD MIDLINE SHIFT. THE PATIENT RECEIVED DDAVP (DESMOPRESSIN) AND PLATELET TRANSFUSION, WAS BROUGHT TO OPERATING ROOM, HAD DECOMPRESSIVE CRANIECTOMY AND DECOMPRESSION OF THE HEMATOMA.

  Patient problems: Hematoma; Hemorrhage, Cerebral; Hemorrhage, Subarachnoid; Stroke/CVA

  MAUDE report 8502228 ↗
• InjuryMar 29, 2019Break; Migration; Break; Migration

  IT WAS REPORTED THAT DURING TREATMENT A BASILAR ARTERY STENOSIS WITH A BALLOON AND THE SUBJECT DEVICE STENT SYSTEM, THE SUBJECT DEVICE STENT WAS SUCCESSFULLY DEPLOYED AND EXPANDED, BUT UPON RETRIEVAL OF ITS DELIVERY SYSTEM, SOMETHING MUST HAVE GRABBED THE PROXIMAL PORTION OF THE DEPLOYED STENT. WHEN THE SUBJECT DEVICE STENT SYSTEM CATHETERS WERE REMOVED, THE SYSTEM "JUMPED" (I.E. RELEASED ENERGY), AND UPON REMOVAL FROM THE BODY, SHOWED THAT PART OF THE SUBJECT DEVICE STENT HAD BROKEN IN HALF AND WAS REMOVED FROM THE BODY WITH THE CATHETER SYSTEM. THE REST OF THE SUBJECT DEVICE STENT REMAINED IMPLANTED IN THE PATIENT'S BASILAR ARTERY. IN ORDER TO ENSURE THE SUBJECT DEVICE STENT WAS OPPOSING THE WALLS WITHIN THE PATIENT'S BASILAR ARTERY, THE PHYSICIAN THEN TRACKED A MICROCATHETER THROUGH THE LUMEN OF THE STENT IN THE BASILAR AND PROCEEDED TO DEPLOY TWO ANOTHER STENTS INSIDE THE PATIENT'S BASILAR ARTERY. THE PATIENT'S ANGIOGRAPHIC RESULTS LOOKED SATISFACTORY POST-DEPLOYMENT, AND THE PATIENT SHOWED NO ADVERSE CLINICAL EVENTS FROM THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8466955 ↗
• MalfunctionDec 12, 2018Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE DURING STENT (SUBJECT DEVICE) DEPLOYMENT DURING THE PROCEDURE AND UPON REMOVAL, THE STENT DETACHED PREMATURELY INSIDE THE GUIDE CATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8158539 ↗
• DeathOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED FOR SLURRED SPEECH AND RIGHT-SIDED WEAKNESS, GAIT DIFFICULTY. MRI SCAN REVEALED SUBACUTE-LOOKING LEFT MEDIAL PONTINE INFARCT. THE PATIENT UNDERWENT ANGIOPLASTY AND THEN PLACEMENT OF A FIRST STENT SYSTEM (SUBJECT DEVICE). THEREAFTER AN OVERLAPPING 2ND STENT WAS PLACED. POST DILATION WAS PERFORMED. FINAL PROJECTION DEMONSTRATED GOOD STENT APPOSITION. NO RESIDUAL STENOSIS AND EXCELLENT FLOW TO DISTAL VESSELS. AFTER PROCEDURE, MRI REVEALED LEFT PONS INFARCTION. THERE WAS EVIDENCE OF EXPANDING PONTINE INFARCT OVER THE TIME. NEUROLOGICALLY, ON EXAMINATION, IT APPEARED THAT THE PATIENT HAD A LOCKED -IN SYNDROME AND REMAINED ON MECHANICAL VENTILATOR. HE CONTINUED A CARDENE DRIP. HE COULD NOT BE ANTICOAGULATED BECAUSE OF THE BRAIN INJURY. ULTIMATELY, THERE WAS EVIDENCE OF MULTIPLE EMBOLIC STROKES INVOLVING THE CEREBELLUM AND CEREBRUM. THE PATIENT DEVELOPED CEREBRAL EDEMA AND THEN BRAINSTEM HERNIATION. ALONG WITH THAT. HE DEVELOPED HYPERGLYCEMIA, ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND NEUROGENIC SHOCK. THE PATIENT DIED 5 DAYS POST PROCEDURE. THE PHYSICIAN ASSESSED THAT THE ADVERSE EVENTS WERE UNLIKELY TO BE RELATED TO THE SUBJECT DEVICE. THE OTHER POSSIBLE CO

  Patient problems: Death; Hyperglycemia; Neurogenic Shock; Respiratory Distress; Stroke/CVA

  MAUDE report 7827945 ↗
• DeathAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED FOR SLURRED SPEECH AND RIGHT-SIDED WEAKNESS, GAIT DIFFICULTY. MRI SCAN REVEALED SUBACUTE-LOOKING LEFT MEDIAL PONTINE INFARCT. THE PATIENT UNDERWENT ANGIOPLASTY AND THEN PLACEMENT OF A FIRST STENT SYSTEM. THEREAFTER AN OVERLAPPING 2ND STENT (SUBJECT DEVICE) WAS PLACED. POST DILATION WAS PERFORMED. FINAL PROJECTION DEMONSTRATED GOOD STENT APPOSITION. NO RESIDUAL STENOSIS AND EXCELLENT FLOW TO DISTAL VESSELS. AFTER PROCEDURE, MRI REVEALED LEFT PONS INFARCTION. THERE WAS EVIDENCE OF EXPANDING PONTINE INFARCT OVER THE TIME. NEUROLOGICALLY, ON EXAMINATION, IT APPEARED THAT THE PATIENT HAD A LOCKED -IN SYNDROME AND REMAINED ON MECHANICAL VENTILATOR. HE CONTINUED A CARDENE DRIP. HE COULD NOT BE ANTICOAGULATED BECAUSE OF THE BRAIN INJURY. ULTIMATELY, THERE WAS EVIDENCE OF MULTIPLE EMBOLIC STROKES INVOLVING THE CEREBELLUM AND CEREBRUM. THE PATIENT DEVELOPED CEREBRAL EDEMA AND THEN BRAINSTEM HERNIATION. ALONG WITH THAT. HE DEVELOPED HYPERGLYCEMIA, ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND NEUROGENIC SHOCK. THE PATIENT DIED 5 DAYS POST PROCEDURE. THE PHYSICIAN ASSESSED THAT THE ADVERSE EVENTS WERE UNLIKELY TO BE RELATED TO THE SUBJECT DEVICE. THE OTHER POSSIBLE CO

  Patient problems: Death; Hyperglycemia; Neurogenic Shock; Respiratory Distress; Stroke/CVA

  MAUDE report 7827854 ↗
• MalfunctionAug 13, 2018Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE STENT DELIVERY WIRE BROKE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7779199 ↗

Other Stryker Corporation products

• RemB7 models · 3,073 reports
• Prime Series21 models · 1,548 reports · 2 recalls
• TARGET114 models · 1,077 reports
• ProCuity17 models · 368 reports · 13 recalls
• Spetzler-Malis20 models · 7 reports · 19 recalls
• SYNCHRO 28 models · 313 reports · 9 recalls
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls