Zoom 88 Large Distal Platform ICTC088110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00812212030368), received between Jun 30, 2022 and Mar 12, 2026 — classified as 1 death, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY OF THE M1 SEGMENT UTILIZING ZOOM 88, THIRD PARTY GUIDEWIRE AND SHEATH. THE PATIENT'S ANATOMY WAS TORTUOUS. A TOTAL OF THREE PASSES WERE COMPLETED, RESULTING IN SUCCESSFUL CLOT REMOVAL. FOLLOWING PHYSICAL INSPECTION OF THE RETURNED DEVICE, THE DISTAL PORTION OF ZOOM 88 WAS FOUND TO BE FRACTURED. THE PATIENT'S POST PROCEDURE STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24584305 ↗
• MalfunctionJan 14, 2026Break; Material Separation

  IT WAS REPORTED THAT DURING A VENOUS SINUS STENTING PROCEDURE THE PHYSICIAN USED A ZOOM 88 TO NAVIGATE TO THE TRANSVERSE SINUS. THERE WAS PRESENCE OF STENOSIS AND/OR CALCIFICATION. ZOOM 88 SUCCESSFULLY CROSSED THE LESION, AND A THIRD-PARTY STENT WAS DEPLOYED. UPON REMOVAL OF ZOOM 88 FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE DISTAL 5 CM OF THE DEVICE WAS BROKEN. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24076100 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH A STROKE AND A SMALL VESSEL DISSECTION. THE LOCATION OF THE DISSECTION WAS HIGH INTERNAL CAROTID ARTERY (ICA). DURING THE PROCEDURE, THE VESSEL BECAME FULLY DISSECTED WHILE THE ZOOM 88 AND THIRD-PARTY WIRE WERE IN THE VESSEL. MULTIPLE STENTS WERE PLACED FOR TREATMENT. ACCORDING TO THE PHYSICIAN, THE ZOOM 88 DID NOT CAUSE THE DISSECTION. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT ALREADY HAD A SMALL DISSECTION PRIOR TO THE PROCEDURE, WHICH ENLARGED DURING THE CASE. IT IS UNKNOWN IF THE ZOOM 88 DEVICE CAUSED OR CONTRIBUTED TO DISSECTION ENLARGEMENT. THERE WAS NO DEVICE MALFUNCTION REPORTED FOR THE ZOOM 88, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 23835118 ↗
• DeathJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 67-YEAR-OLD MALE PATIENT WAS BEING TREATED FOR AN OCCLUSION AT THE LEFT M1 SEGMENT. A ZOOM 88 ACCESS CATHETER AND A THIRD-PARTY INSERT CATHETER WERE INTRODUCED INTO THE LEFT COMMON CAROTID ARTERY (CCA) AS A SYSTEM. A ROADMAP ANGIOGRAM WAS COMPLETED OF THE CCA TO VISUALIZE THE CAROTID BIFURCATION. A DIAGNOSTIC CATHETER WAS USED TO SELECT THE INTERNAL CAROTID ARTERY (ICA) OVER A GLIDEWIRE. THE ZOOM 88 WAS THEN ADVANCED AND PARKED AT THE ICA CAVERNOUS. DURING THE FIRST AND SECOND PASSES, A THIRD-PARTY MICROCATHETER AND MICROWIRE WERE ADVANCED THROUGH A ZOOM 71 ASPIRATION CATHETER AS A SYSTEM INTO THE ZOOM 88. THE ZOOM 71 WAS ADVANCED TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED. THE ZOOM 71 CATHETER WAS REMOVED UNDER CONTINUOUS ASPIRATION FROM THE PATIENT. A CONTRAST RUN SHOWED THE THROMBUS WAS NOT ASPIRATED. DURING THE THIRD PASS, A DIFFERENT THIRD-PARTY MICROCATHETER AND MICROWIRE WERE ADVANCED THROUGH THE ZOOM 88 PAST THE M1 OCCLUSION. THE MICROWIRE WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH A STENT RETRIEVER. THE STENT RETRIEVER WAS ADVANCED AND ALLOWED TO SET IN THE CLOT FOR 5 MINUTES. THE STENT RETRIEVER WAS REMOVED; HOWEVER, THE THROMBUS WAS NOT CAPTURED WITHI

  Patient problems: Stroke/CVA

  MAUDE report 19778936 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 57-YEAR-OLD MALE WAS TREATED FOR A LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS OCCLUSION. A SMALL SKIN INCISION WAS MADE, AND AN 8 FRENCH SHEATH WAS PLACED. ACCESS WAS OBTAINED WITH A GUIDEWIRE, THIRD-PARTY CATHETER, AND A ZOOM 88. DURING THE FIRST PASS, THE ZOOM 88 WAS NAVIGATED TO THE LEFT ICA TO TERMINUS OVER THE GUIDEWIRE WHILE PUMP ASPIRATION WAS APPLIED. THE ZOOM 88 CATHETER WAS WITHDRAWN UNTIL FREE FLOW OF BLOOD WAS OBTAINED. ANGIOGRAPHY WAS PERFORMED. DURING THE SECOND PASS, A ZOOM 55 WAS NAVIGATED OVER A THIRD-PARTY MICROCATHETER AND MICROWIRE INTO THE LEFT M2 INFERIOR DIVISION OCCLUSION THROUGH THE ZOOM 88. ASPIRATION WAS APPLIED TO THE ZOOM 55. THE ZOOM 55 WAS REMOVED, AND ANGIOGRAPHY WAS PERFORMED. A THIRD PASS WAS ATTEMPTED WITH A ZOOM 35 CATHETER ADVANCING OVER A MICROWIRE; HOWEVER, THE CATHETER COULD NOT BE NAVIGATED DISTALLY ENOUGH TO ENGAGE THE CLOT. THE ZOOM 88, ZOOM 35, AND THE MICROWIRE WERE REMOVED AS A SYSTEM FROM THE PATIENT. HEMOSTASIS IN THE RIGHT GROIN WAS OBTAINED. THE PATIENT ACHIEVED PARTIAL REPERFUSION WITH A TICI 2B. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. APPROXIMATELY 20 MINUTES LATER, A DYNA-CT SCAN REVEALED A SMALL AMOUNT OF SUBARACHNOID HE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18692030 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) M1 SEGMENT. ACCESS WAS OBTAINED WITH A GUIDEWIRE, THIRD- PARTY MICROCATHETER, AND ZOOM 88. THE ZOOM 88 WAS POSITIONED WITHIN THE ICA (EXACT LOCATION WAS NOT PROVIDED). DURING PASS 1, THE GUIDEWIRE AND MICROCATHETER WERE REPLACED WITH A NEW MICROWIRE AND ZOOM 35. THE ZOOM 55 WAS ADVANCED OVER THE ZOOM 35 TO THE CLOT LOCATION. ASPIRATION WAS APPLIED TO THE ZOOM 55, AND PART OF THE CLOT WAS CAPTURED. A MTICI 2A RECANALIZATION WAS ACHIEVED. THE DISTAL CLOT REMAINED IN THE M2 SEGMENT. THE PHYSICIAN USED THE SAME DEVICES AND SAME APPROACH AS IN PASS 1 FOR PASSES 2 THROUGH 5. AT THE END OF PASS 5, THE DISTAL CLOT IN THE M2 SEGMENT WAS ASPIRATED WITH A FINAL MTICI 2B SCORE. THERE WAS NO EVIDENCE OF VESSEL DISSECTION, CONTRAST EXTRAVASATION, EMBOLI IN NEW TERRITORIES, OR OTHER UNTOWARD EVENTS. THE PATIENT TOLERATED THE PROCEDURE WELL, REMAINED STABLE, AND WAS SUBSEQUENTLY TRANSFERRED TO INTENSIVE CARE UNIT (ICU). THERE WAS NO DEVICE MALFUNCTION OR PATIENT SEQUELAE REPORTED. APPROXIMATELY FOUR HOURS AFTER THE FIRST THROMBECTOMY CASE, THE PATIENT DEVELOPED WORSENING SYMPTOMS AN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18315041 ↗
• MalfunctionAug 16, 2023Break; Material Separation; Break; Material Separation

  A 78-YEAR-OLD MALE WAS TREATED FOR AN OCCLUSION AT THE RIGHT ICA (INTERNAL CAROTID ARTERY) M1 SEGMENT. THE ZOOM 88 ACCESS CATHETER WAS INSERTED INTO AN 8 FRENCH (FR) SHEATH THROUGH A THIRD-PARTY RHV (ROTATING HEMOSTASIS VALVE). THE THIRD-PARTY RHV WAS REPORTED TO HAVE A SMALLER INNER DIAMETER 0.096" (2.44MM)/7.3FR THAN THE ZOOM 88 CATHETER OUTER DIAMETER OF 0.110" (2.8 MM)/8FR. DURING THE INTRODUCTION, THE ZOOM 88 BECAME STUCK IN THE RHV AND THE CATHETER BROKE. THE LOCATION OF THE BREAK IS APPROXIMATELY 15CM FROM THE DISTAL END OF THE ZOOM 88. THE RHV AND ZOOM 88 WERE REMOVED. THE SEPARATED SEGMENT REMAINED INSIDE THE RHV AND DID NOT ENTER THE PATIENT. A BALLOON GUIDE CATHETER WAS USED TO CONTINUE WITH THE PROCEDURE. THE CLOT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO PATIENT SEQUELAE WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561183 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 80-YEAR-OLD MALE WAS TREATED FOR A RIGHT CAROTID OCCLUSION FROM THE CAVERNOUS TO M1 SEGMENT. RIGHT FEMORAL ACCESS WAS OBTAINED WITH A ZOOM 88 ACCESS CATHETER OVER A MICROWIRE AND A THIRD-PARTY MICROCATHETER. A ZOOM 71 WAS ADVANCED THROUGH THE ZOOM 88 OVER THE MICROCATHETER TO THE FACE OF THE CLOT IN THE CAVERNOUS SEGMENT. THE ZOOM 88 WAS THEN ADVANCED OVER THE ZOOM 71 AND MICROCATHETER TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED TO THE ZOOM 88. THE CLOT IN THE TERMINUS AND ANTERIOR CEREBRAL ARTERY (ACA) WAS PARTIALLY REMOVED; HOWEVER, THE M1 SEGMENT REMAINED OCCLUDED. A SECOND PASS WITH THE SAME ZOOM 71, MICROCATHETER AND ZOOM 88 WAS COMPLETED ADVANCING THE ZOOM 71 THROUGH THE ZOOM 88 OVER THE MICROCATHETER TO THE M1 SEGMENT. ASPIRATION WAS APPLIED FOR APPROXIMATELY TWO MINUTES TO THE ZOOM 71 CATHETER, AND THE CLOT WAS REMOVED. A TICI 2A RECANALIZATION WAS NOTED. A THIRD PASS WITH THE SAME ZOOM 71, MICROCATHETER, AND ZOOM 88 WAS COMPLETED. ZOOM 71 WAS ADVANCED THROUGH THE ZOOM 88 OVER THE MICROCATHETER TO THE INFERIOR M2 SEGMENT. THE ZOOM 88 WAS THEN ADVANCED OVER THE ZOOM 71 AND MICROCATHETER TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED TO THE ZOOM 88. THE CLOT IN

  Patient problems: Cerebral Edema; Intracranial Hemorrhage

  MAUDE report 17127584 ↗
• InjuryApr 19, 2023Break; Material Separation; Break; Material Separation

  A 62-YEAR-OLD FEMALE PATIENT WAS FOUND TO HAVE AN OCCLUSION ON THE CAROTID TERMINUS. ACCESS WAS OBTAINED WITH A ZOOM 88 CATHETER, A COMPETITOR MICROCATHETER, AND GUIDEWIRE. THE ZOOM 88 WAS POSITIONED PROXIMAL TO THE CAROTID TERMINUS (BELOW THE LEVEL OF THE OPHTHALMIC). A ZOOM 71, ZOOM 35, AND ANOTHER GUIDEWIRE WERE ADVANCED TOWARDS THE CLOT AND THREE PASSES WERE PERFORMED WITH THE ZOOM 71. THE ZOOM 71 AND ZOOM 35 WERE THEN REMOVED FROM THE GUIDE CATHETER. FOR THE FOURTH PASS, A SOLITAIRE STENT RETRIEVER WAS ADVANCED PAST THE CAROTID TERMINUS THROUGH THE CLOT AND THEN REMOVED FROM THE ZOOM 88. THEN 8CC OF CONTRAST WAS ADMINISTERED WITH A 10CC SYRINGE THROUGH THE ZOOM 88. IMAGING SHOWED A VESSEL RUPTURE AT THE CAROTID TERMINUS/ INTERNAL CAROTID ARTERY (ICA). A HYPER OCCLUSION BALLOON, COILS, AND AN EXTERNAL VENTRICULAR DRAIN WERE USED TO TREAT THE RUPTURE. THE TREATING INTERVENTIONAL RADIOLOGIST (IR) BELIEVES THE RUPTURE WAS DUE TO 8CC OF CONTRAST DELIVERED TO A CLOSED SPACE HIGH ABOVE THE OCCLUDED PETROUS. HOWEVER, THE IR COULD NOT RULE OUT THE STENT RETRIEVER, GUIDEWIRE, OR THE ZOOM 88 AS THE CAUSE. THE PHYSICIAN DID NOT FIND ANY DAMAGE TO THE ZOOM 88, ZOOM 71, OR ZOOM 35 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773465 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 87-YEAR-OLD FEMALE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE TERMINUS INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN INITIALLY COULD NOT ADVANCE THE ZOOM 88 ACCESS CATHETER PAST THE HORIZONTAL PETROUS. AFTER THE PHYSICIAN'S THIRD ATTEMPT, A COMPETITOR'S GUIDEWIRE, ZOOM 55 AND ZOOM 35 ASPIRATION CATHETERS WERE INSERTED. THIS ALLOWED THE ZOOM 88 TO MOVE PAST THE HORIZONTAL PETROUS AND ADVANCE UP TO THE CAVERNOUS. THE PHYSICIAN NOTED ATHEROSCLEROSIS AND A DISEASED ICA. THE PHYSICIAN HAD A DUAL ASPIRATION SET-UP WITH THE ZOOM 88 ACCESS CATHETER AND ZOOM 55 ASPIRATION CATHETER. THE ZOOM 55 AND ZOOM 35 ASPIRATION CATHETERS WERE ADVANCED OVER THE COMPETITOR GUIDEWIRE TO THE FACE OF THE CLOT IN THE TERMINUS ICA. ZOOM 35 WAS REMOVED. ENGAGING THE CLOT WITH ZOOM 55, THE PHYSICIAN STARTED ASPIRATION AND RETRACTED THE ZOOM 55 CATHETER WITH THE CLOT TO THE ZOOM 88. A SECOND ASPIRATION WAS STARTED WITH THE ZOOM 88 AS THE ZOOM 55 AND CLOT WERE RETRACTED THROUGH THE ACCESS CATHETER (ZOOM 88). DURING A CONTRAST RUN, ANOTHER OCCLUSION WAS OBSERVED IN THE M1 SEGMENT. ON ITS SECOND PASS, THE PHYSICIAN SUCCESSFULLY ADVANCED THE SAME ZOOM 55 TO THE M1 SEGMENT AND ASPI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16508347 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION, EXTENSIVE CEREBROVASCULAR DISEASE WAS BEING TREATED FOR A CAROTID TERMINUS OCCLUSION WITH THE CLOT IN THE INTERNAL CAROTID ARTERY (ICA) TERMINUS. WHEN ADVANCING THE ZOOM 88 CATHETER PAST AN ANEURYSM THAT WAS NOT INITIALLY VISUALIZED, A PERFORATION OF THE ANEURYSM OCCURRED CREATING A CAVERNOUS CAROTID FISTULA (CCF). THERE WAS NO TREATMENT PERFORMED FOR THE CCF. THE TERMINUS CLOT WAS SUCCESSFULLY REMOVED, AND VESSEL PERFUSION RESTORED. PER THE CASE NOTES PROVIDE BY THE PHYSICIAN, RIGHT FEMORAL ARTERY WAS PERCUTANEOUSLY ACCESSED WITH A 4F MICROPUNCTURE SET AND A SHORT 8F SHEATH WAS THEN PLACED. 5F DIAGNOSTIC CATHETER WAS ADVANCED OVER AN ANGLED GUIDEWIRE INTO THE AORTIC ARCH FOR THE INITIAL ANGIOGRAM. IMAGING SHOWED EXTENSIVE INTRACRANIAL AND EXTRA CRANIAL ATHEROSCLEROTIC DISEASE AND EXTENSIVE PLAQUE THROUGHOUT THE CAROTID BULB WITH A HIGH-GRADE STENOSIS AT THE LEFT COMMON CAROTID ARTERY AND CERVICAL INTERNAL CAROTID. DIAGNOSTIC CATHETER WAS THEN EXCHANGED FOR A ZOOM 88 OVER GUIDEWIRE WHICH WAS ADVANCED INTO THE DISTAL CERVICAL LEFT ICA. A ZOOM 71 WAS THEN ADVANCED OVER A 0.16" GUIDEWIRE, AND ADVANCED JUST BEYOND THE CLOT UNDER SUCTION,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877126 ↗