Zoom CatheterRecalls & reported problems across all models
Imperative Care, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 89
- Deaths reported
- 8
- Injuries reported
- 51
- Recalls
- 0
We found 4 models of Zoom Catheter by Imperative Care, Inc. in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Feb 24, 2022 and Sep 28, 2026 — classified as 8 deaths, 51 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Break” (61 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
Most reported Zoom Catheter problems
Device problems
- Break61
- Material Separation59
- Adverse Event Without Identified Device or Use Problem20
- Material Deformation6
- Stretched3
- Use of Device Problem3
- Detachment of Device or Device Component2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Foreign Body In Patient8
- Hemorrhage/Blood Loss/Bleeding7
- Perforation of Vessels6
- Vascular Dissection6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Device Embedded In Tissue or Plaque5
- Extravasation4
Zoom Catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zoom Catheter ICRC071137Catheter, Thrombus Retriever3 deaths50 reports
- Zoom Catheter ICRC055137Catheter, Thrombus Retriever3 deaths23 reports
- Zoom Catheter ICRC035158Catheter, Thrombus Retriever1 death11 reports
- Zoom Catheter ICRC045144Catheter, Thrombus Retriever1 death5 reports
Recent Zoom Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Break; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926368 ↗DeathJul 8, 2026Break; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE ISCHEMIC STROKE INVOLVING A TANDEM OCCLUSION, WITH THE TARGET CLOT LOCATED IN THE MIDDLE CEREBRAL ARTERY (MCA). ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY USING A ZOOM SUPPORT CATHETER WHICH WAS INTRODUCED THROUGH A THIRD-PARTY SHEATH. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT/RETRACTION THROUGH THE CAROTID ARTERY. IMAGING INDICATED THAT THE ACCESS CATHETER AS WELL AS ZOOM 35 KINKED DUE TO EXTREME TORTUOUS ANATOMY. THE PHYSICIAN EXCHANGED THE ZOOM SUPPORT ACCESS CATHETER FOR A THIRD-PARTY GUIDE CATHETER. UPON REMOVAL, THE ZOOM 35 CATHETER WAS FOUND TO HAVE FRACTURED, WITH SEPARATION OCCURRING APPROXIMATELY 30 CM FROM THE DISTAL END. AN ATTEMPT TO RETRIEVE THE SEPARATED CATHETER SEGMENT USING A SNARE WAS UNSUCCESSFUL, AND THE DISTAL CATHETER SEGMENT REMAINED WITHIN THE PATIENT'S VASCULATURE. THE PROCEDURE WAS SUBSEQUENTLY CONCLUDED, AS THE EARLIER THROMBECTOMY ATTEMPT USING THE ZOOM 35 CATHETER HAD BEEN UNSUCCESSFUL. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED A COUPLE OF DAYS FOLLOWING THE PROCEDURE; HOWEVER, THE EXACT DATE OF DEATH WAS NOT KNOWN. BASED ON THE INFORMATION PROVIDED, THE
Patient problems: Insufficient Information
MAUDE report 25756162 ↗InjuryJun 30, 2026Break; Material Separation; Detachment of Device or Device Component
DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR A LEFT PROXIMAL M1 OCCLUSION, ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY USING A THIRD-PARTY ACCESS GUIDE CATHETER. DURING THE SECOND PASS, RESISTANCE WAS ENCOUNTERED WHILE WITHDRAWING THE ZOOM 71 THROUGH THE THIRD-PARTY GUIDE CATHETER. IT WAS REPORTED THAT THE THIRD-PARTY GUIDE CATHETER HAD KINKED, CAUSING THE DISTAL TIP OF THE ZOOM 71 TO FRACTURE NEAR THE KINK SITE. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED USING AN ADDITIONAL ASPIRATION CATHETER. THE PHYSICIAN THEN EXCHANGED FOR AN ALTERNATIVE THIRD-PARTY DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT REMAINED STABLE FOLLOWING THE EVENT, WITH NO REPORTED ADVERSE CLINICAL OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25672889 ↗MalfunctionMay 27, 2026Break; Material Separation; Use of Device Problem; Material Deformation
DURING A THROMBECTOMY PROCEDURE TARGETING A CLOT LOCATED AT THE INTERNAL CAROTID ARTERY (ICA) TERMINUS AND SUBSEQUENTLY THE DISTAL M1 OR PROXIMAL M2, FEMORAL ACCESS WAS OBTAINED USING A ZOOM SUPPORT DEVICE. TIGHT STENOSIS AND AN S-TURN WITHIN THE VERTEBRAL ARTERY RESULTED IN THE ZOOM 88 BEING POSITIONED WITHIN THE SUBCLAVIAN ARTERY. THE ZOOM 55 WAS UNABLE TO ADVANCE THROUGH THE STENOSIS AROUND THE S-TURN. AFTER THREE ATTEMPTED PASSES WITH THE ZOOM 55, A ZOOM 35 WAS LOADED INTO THE ZOOM 55 ON THE BACK TABLE OUTSIDE THE PATIENT. RESISTANCE WAS ENCOUNTERED WHILE LOADING ZOOM 35 INTO THE ZOOM 55 CATHETER AND UPON WITHDRAWAL OF ZOOM 35, THE ZOOM 55 ACCORDIONED AND WAS OBSERVED TO SEPARATE WITHIN THE MID-SHAFT OUTSIDE THE BODY. THE BROKEN PIECE WAS OUTSIDE THE PATIENT AND NO INTERVENTION WAS NEEDED. THE PHYSICIAN USED A THIRD-PARTY DEVICE AND SWITCHED TO RADIAL ACCESS FOR SUCCESSFUL COMPLETION OF THE PROCEDURE. IT WAS REPORTED THAT THERE WAS SEVERE VESSEL TORTUOSITY, INCLUDING STENOSIS AT THE TAKEOFF OF THE LEFT VERTEBRAL ARTERY WITH AN S-SHAPED CONFIGURATION. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED A SUBDURAL HEMORRHAGE REPORTEDLY DUE TO ADMINISTRATION OF TISSUE PLASMINOGEN ACT
Patient problems: Insufficient Information
MAUDE report 25307948 ↗MalfunctionApr 23, 2026Break; Material Separation; Material Deformation
IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR M1 SEGMENT, THE ZOOM 71 CATHETER WAS REMOVED AND OBSERVED TO HAVE UNRAVELED OUTSIDE THE PATIENT. A TOTAL OF TWO PASSES WERE PERFORMED, WITH THE ISSUE OCCURRING ON THE SECOND PASS. UPON REMOVAL, DAMAGE WAS IDENTIFIED APPROXIMATELY 4 CM FROM THE DISTAL TIP. RESISTANCE WAS ENCOUNTERED DURING RETRACTION THROUGH THE THIRD PARTY ROTATING HEMOSTATIC VALVE (RHV). THE PHYSICIAN USED ANOTHER ZOOM 71 TO COMPLETE THE PROCEDURE. THE CASE INVOLVED SIGNIFICANT VESSEL TORTUOSITY; HOWEVER, IT IS UNKNOWN WHETHER PATIENT ANATOMY DIRECTLY CONTRIBUTED TO THE EVENT. THE PATIENT OUTCOME WAS REPORTED AS POOR BUT WAS ASSESSED AS UNRELATED TO THE DEVICE ISSUE. PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974574 ↗DeathFeb 12, 2026Material Deformation
THROMBECTOMY WAS PERFORMED FOR AN M1 STROKE. THE PHYSICIAN UTILIZED A THIRD-PARTY WIRE, ZOOM SIM AND ZOOM 88. THE 88 REMAINED LOW IN THE CERVICAL ICA WHILE A ZOOM 71, THIRD-PARTY MICROCATHETER AND THIRD-PARTY NEURO WIRE WERE ADVANCED TO THE CLOT. MANUAL ASPIRATION WAS PERFORMED WITH A SYRINGE THROUGH ZOOM 71 WHEN THE PHYSICIAN FELT RESISTANCE AND SLIPPING OF THE ZOOM 88 AND THE PHYSICIAN LOST ACCESS. PHYSICIAN REMOVED EVERYTHING INCLUDING THE ZOOM 88. HE WENT BACK UP WITH A THIRD-PARTY ACCESS CATHETER AND A NEW ZOOM 71 AND WAS ABLE TO OPEN THE M1 SUCCESSFULLY. THERE WERE DISTAL BLOCKAGES THAT HE ATTEMPTED TO REACH WITH A ZOOM 55 UNSUCCESSFULLY, AT WHICH POINT THE PROCEDURE WAS STOPPED. POST PROCEDURE, IT WAS NOTICED THAT THE ZOOM 88 WAS KINKED MID-SHAFT AND THE ORIGINAL ZOOM 71 WAS KINKED NEAR THE DISTAL TIP. THE KINKS ON THE ZOOM CATHETERS WERE ATTRIBUTED TO THE PATIENT'S TORTUOUS ANATOMY AND DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. THE THIRD-PARTY FEMORAL SHEATH WAS ALSO KINKED AT THE GROIN ACCESS SITE. POST PROCEDURE, AN INTERCRANIAL PERFORATION WAS IDENTIFIED. ADDITIONALLY, POST PROCEDURE A RLE (RIGHT LOWER EXTREMITY) ISCHEMIA WAS NOTED, AND A HEAD CT WAS PERFORMED WHICH CO
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24325250 ↗MalfunctionJan 27, 2026Break; Material Separation; Use of Device Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY WHERE A PROXIMAL SUB-OCCLUSIVE CLOT WAS PRESENT IN THE INFERIOR BRANCH OF THE DISTAL M2 SEGMENT AND A FULLY OCCLUSIVE DISTAL CLOT WAS PRESENT IN THE M3 SEGMENT. THE PHYSICIAN ADVANCED A ZOOM 35 CATHETER TO THE INFERIOR BRANCH OF THE M2 SEGMENT AND SUCCESSFULLY ASPIRATED THE PROXIMAL OCCLUSION IN A SINGLE PASS USING MANUAL ASPIRATION WITH A 20-CC SYRINGE. FOLLOW UP ANGIOGRAPHY CONFIRMED FULL RECANALIZATION OF THE M2 SEGMENT AND REVEALED A DISTAL OCCLUSION IN THE M3 SEGMENT AT THE LEVEL OF THE SYLVIAN FISSURE. THE PHYSICIAN THEN ADVANCED THE ZOOM 35 CATHETER AND A THIRD-PARTY MICROWIRE TO THE SITE OF THE DISTAL CLOT WITHOUT ENCOUNTERING RESISTANCE. ASPIRATION OF THE DISTAL CLOT WAS PERFORMED AND DURING THIS PROCESS, THE PHYSICIAN FELT THE CLOT CORK ON THE ZOOM 35 CATHETER AND BEGAN WITHDRAWING THE DEVICE. INCREASED RESISTANCE WAS NOTED DURING REMOVAL, BUT THE PHYSICIAN CONTINUED TO WITHDRAW THE CATHETER. WHILE OBSERVING REMOVAL AT THE RHV, HE NOTED UNDER FLUOROSCOPY THAT THE DISTAL SEGMENT OF THE CATHETER WAS NOT MOVING SYNCHRONOUSLY. THE PHYSICIAN THEN OBSERVED A WIRE LIKE FILAMENT AT THE RHV, INDICATING THAT ONLY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24196556 ↗InjuryJan 21, 2026Break; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY OF THE LEFT M1 SEGMENT. THE INTERNAL CAROTID ARTERY (ICA) WAS NOTED TO BE HIGHLY TORTUOUS DISTAL TO THE BIFURCATION. ADVANCEMENT OF THE ZOOM 88, ZOOM 71 AND THIRD-PARTY STENT RETRIEVAL WAS PERFORMED SUCCESSFULLY. DURING THE REMOVAL OF ZOOM 71 AND THIRD-PARTY STENT RETRIEVER, SIGNIFICANT RESISTANCE WAS FELT, AND THE ZOOM 71 COULD NOT BE WITHDRAWN WHICH RESULTED IN REMOVAL OF THE THIRD-PARTY STENT RETRIEVER, ZOOM 88 AND THE ZOOM 71 AS A SYSTEM. THE ZOOM 71 WAS FOUND TO BE FRACTURED INTO TWO SEGMENTS; HOWEVER, ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. FOLLOWING REMOVAL OF THE DEVICE, SOME EXTRAVASATION WAS OBSERVED IN THE PATIENT. THE PROCEDURE COULD NOT BE COMPLETED.
Patient problems: Extravasation
MAUDE report 24138975 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY FOR AN ACUTE ISCHEMIC STROKE INVOLVING THE LEFT M1/M2 ARTERIES. THE PHYSICIAN UTILIZED A THIRD-PARTY MEDIUM CARRIER DELIVERY CATHETER ALONG WITH ZOOM 7X TO ACCESS THE CLOT LOCATED IN THE DISTAL M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). ZOOM 7X WAS POSITIONED IN THE DISTAL M1 AT THE BIFURCATION OF THE SUPERIOR & INFERIOR BRANCHES. AFTER THE FIRST PASS WITH ZOOM 7X, THE INFERIOR DIVISION WAS PATENT, WHILE THE SUPERIOR DIVISION REMAINED OCCLUDED. THE PHYSICIAN THEN ADVANCED A ZOOM 45 INTO THE SUPERIOR BRANCH BUT WAS UNABLE TO ADVANCE FAR ENOUGH, SO DEPLOYED A THIRD-PARTY STENT RETRIEVER ACROSS THE OCCLUSION, FOLLOWED BY ZOOM 45, AND A SECOND PASS WAS PERFORMED. SOME IMPROVEMENT WAS NOTED IN THE M2 SUPERIOR BRANCH; HOWEVER, FLOW BECAME STAGNANT IN THE INFERIOR BRANCH. AT THIS POINT, A DISSECTION WAS OBSERVED AT THE M1 BIFURCATION OF THE SUPERIOR AND INFERIOR BRANCHES OF THE LEFT MCA, WHICH THE PHYSICIAN ATTRIBUTED AS LIKELY RESULTING FROM ZOOM 7X. THE DISSECTION BECAME PROMINENT AS THE PROCEDURE PROGRESSED; ADDITIONAL PASSES WERE ATTEMPTED WITH A ZOOM 45 AND A ZOOM 35 IN THE INFERIOR BRANCH RESULTING IN TEMPORARY RECANALI
Patient problems: Thrombosis/Thrombus; Vascular Dissection
MAUDE report 23857421 ↗InjurySep 11, 2025Break; Material Separation; Use of Device Problem; Failure to Advance; Break; Material Separation; Use of Device Problem; Failure to Advance
IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN M1 STROKE. A THIRD-PARTY ACCESS CATHETER WAS USED AND POSITIONED IN THE LOW TO MID CERVICAL INTERNAL CAROTID ARTERY (ICA). A ZOOM 71 WAS ADVANCED TOWARDS THE M1 OVER A ZOOM 35- AND THIRD-PARTY GUIDEWIRE. THE ZOOM 71 REACHED THE M1 AND WAS UNABLE TO ADVANCE FURTHER. UPON REVIEW THE PHYSICIAN NOTICED THE ZOOM 71 HAD PROLAPSED IN THE CERVICAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ATTEMPTED TO RETRACT THE ZOOM 71 TO STRAIGHTEN THE CATHETER. DURING THIS ATTEMPT, THE DEVICE BECAME IMPINGED AGAINST THE THIRD-PARTY ACCESS CATHETER AND SEPARATED. A SNARE WAS USED TO RETRIEVE THE DISTAL SEGMENT OF THE ZOOM 71 SUCCESSFULLY. THE PROCEDURE WAS THEN COMPLETED USING A NEW ZOOM 71 CATHETER. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23029505 ↗InjuryAug 25, 2025Break; Material Separation; Material Deformation; Break; Material Separation; Material Deformation
IT WAS REPORTED THAT A PATIENT UNDERWENT MECHANICAL THROMBECTOMY FOR THE REMOVAL OF CLOT IN THE MIDDLE CEREBRAL ARTERY (MCA) AND ANTERIOR CEREBRAL ARTERY (ACA). DURING THE FIRST PASS, THE ZOOM 71 CATHETER BROKE AT THE DISTAL END. A NEW ZOOM 71 CATHETER WAS UTILIZED WITH A THIRD-PARTY DEVICE TO CONTINUE THE PROCEDURE FOR REMOVAL OF CLOT. DURING THE THIRD PASS, THE SECOND ZOOM 71 CATHETER ALONG WITH THE THIRD-PARTY DEVICE WAS USED TO RETRIEVE THE DISLODGED PORTION OF THE INITIAL ZOOM 71 CATHETER. SUBSEQUENTLY, TWO ADDITIONAL PASSES WERE PERFORMED IN THE ACA WITH ZOOM 45 CATHETER TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT'S ANATOMY WAS TORTUOUS DUE TO A LOOP IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) AND RESISTANCE WAS ENCOUNTERED DURING RETRACTION OF THE ZOOM 71. POST PROCEDURE, THE PATIENT EXPERIENCED ARTERIAL SPASM POSSIBLY RELATED TO HISTORY OF DRUG USE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22889998 ↗InjuryJul 30, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT A PATIENT WITH A TANDEM OCCLUSION IN THE PROXIMAL INTERNAL CAROTID ARTERY (ICA) AND M1/M2 SEGMENT THROMBUS WAS TREATED WITH MECHANICAL THROMBECTOMY USING A THIRD-PARTY ACCESS CATHETER AND ZOOM 55 ASPIRATION CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING AND RETRACTING THE ZOOM 55 ASPIRATION CATHETER THROUGH THE PROXIMAL ICA STENOSIS. UPON REACHING THE CLOT, ASPIRATION DID NOT WORK WELL DUE TO IRREGULAR SUCTION; IMAGING REVEALED THE DEVICE HAD SEPARATED. AT THIS POINT, THE PHYSICIAN REMOVED THE ZOOM 55 CATHETER. UPON REVIEW OF THE ANGIOGRAPH, IT WAS DETERMINED THE DISTAL SEGMENT OF THE CATHETER WAS IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). AN ATTEMPT WAS MADE TO RETRIEVE THE DISTAL SEGMENT USING A SNARE; HOWEVER, THIS APPROACH WAS UNSUCCESSFUL. A THIRD-PARTY BUDDY CATHETER WAS USED TO WEDGE THE DISTAL ZOOM 55 SEGMENT WITHIN ANOTHER THIRD-PARTY CATHETER, AND THE DISTAL SEGMENT WAS SUCCESSFULLY RETRIEVED. THE PHYSICIAN USED ANOTHER ZOOM 55 REPERFUSION CATHETER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT SEQUELAE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22671672 ↗InjuryJul 17, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY FOR TREATMENT OF AN M2 SEGMENT CLOT. THE PHYSICIAN WAS UNABLE TO ACCESS THE FEMORAL ARTERY AND DECIDED TO ACCESS RADIAL ARTERY USING A THIRD-PARTY SHEATH. THE PHYSICIAN WAS UNABLE TO REACH THE M2 CLOT WITH THE ZOOM 55 AND DECIDED TO EXCHANGE ZOOM 55 CATHETER UNDER FLUOROSCOPY FOR A ZOOM 45 REPERFUSION CATHETER. THERE WAS NO FRICTION OR ISSUES DURING THE EXCHANGE OF THE TWO CATHETERS REPORTED. UPON ADVANCEMENT OF THE ZOOM 45 CATHETER INTO THE M1 SEGMENT, A REPEAT FLUOROSCOPIC EVALUATION REVEALED THE TIP OF ZOOM 55 IN THE A1 SEGMENT. CLOT ASPIRATION WAS SUCCESSFULLY PERFORMED USING THE ZOOM 45 CATHETER. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE ZOOM 45 AND EXCHANGED THE THIRD-PARTY SHEATH FOR A ZOOM RDL. A THIRD-PARTY STENT RETRIEVAL DEVICE WAS THEN USED TO EXTRACT THE ZOOM 55 TIP, WHICH WAS SUCCESSFULLY RETRIEVED WITHOUT FURTHER COMPLICATION. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT SEQUELAE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22536123 ↗InjuryJun 12, 2025Break; Material Separation; Break; Material Separation
AN 85-YEAR-OLD-MALE WAS TREATED FOR MECHANICAL THROMBECTOMY TO REMOVE AN OCCLUSION FROM THE RIGHT M1 SEGMENT. THE PATIENT'S ANATOMY WAS REPORTEDLY TORTUOUS. ACCESS WAS OBTAINED USING A THIRD-PARTY ACCESS CATHETER WHICH WAS ADVANCED TO THE FIRST BIG TURN IN THE TORTUOUS LOOP IN DISTAL CERVICAL ICA. THE ZOOM 71 WAS THEN ADVANCED OVER A THIRD-PARTY GUIDEWIRE AND ZOOM 35 TO THE CLOT AT THE PROXIMAL M1 SEGMENT. THE GUIDEWIRE AND ZOOM 35 CATHETER WERE REMOVED. ASPIRATION WAS PERFORMED WITH THE ZOOM 71 CATHETER. AS THE ZOOM 71 CATHETER WAS RETRACTED UNDER ASPIRATION AND THE CLOT WAS REMOVED. DURING THE REMOVAL OF THE ZOOM 71 CATHETER, THE PHYSICIAN FELT RESISTANCE BUT KEPT PULLING BACK THE CATHETER. AS THE PHYSICIAN PULLED BACK ON THE ZOOM 71, THE CATHETER BROKE AROUND 22CM FROM THE DISTAL TIP OF THE CATHETER. A SNARE WAS USED TO RETRIEVE THE BROKEN SEGMENT BUT WAS UNSUCCESSFUL. A STENT RETRIEVER WAS THEN USED TO RETRIEVE THE BROKEN SEGMENT, HOWEVER DURING THE RETRIEVAL ATTEMPT ONLY THE DISTAL 2 CM OF THE BROKEN SEGMENT WAS ABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED. A DAY OR TWO LATER THE PATIENT WAS RETURNED TO THE CATH LAB AND THE PHYSICIAN ATTEMPTED TO USE ASPIRATION AND A STEN
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22199497 ↗InjuryJun 4, 2025Break; Material Separation; Break; Material Separation
A 37-YEAR-OLD FEMALE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY TO REMOVE AN OCCLUSION AT THE RIGHT M1 SEGMENT. ACCESS WAS OBTAINED USING A ZOOM TRACSTAR ACCESS CATHETER. A ZOOM 71 CATHETER WAS ADVANCED THROUGH THE ACCESS CATHETER OVER A THIRD-PARTY GUIDEWIRE TO THE FACE OF THE CLOT. THE FIRST PASS ASPIRATION WAS COMPLETED WITHOUT ANY ISSUES. ON THE SECOND PASS THE PHYSICIAN FELT RESISTANCE AS HE BEGAN TO RETRACT THE ZOOM 71 CATHETER. THE ZOOM 71 CATHETER BROKE APPROXIMATELY 8-10 CM FROM TIP. THE BROKEN CATHETER PIECE WAS RETRIEVED WITH A THIRD-PARTY MICROCATHETER AND STENT RETRIEVER. THE PATIENT WAS THEN STENTED IN THE M1 SEGMENT DUE TO A VESSEL DISSECTION THAT WAS UNRELATED TO THE ZOOM CATHETERS. THE PATIENT WAS REPORTED TO BE DOING WELL. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION BUT WERE UNSUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22146514 ↗
Other Imperative Care, Inc. products
All Imperative Care, Inc. 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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