Zoom 7X Catheter ICRC07X137Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00812212030757), received between Sep 9, 2025 and Jun 22, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• InjuryJun 22, 2026Break; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING THE INTERNAL CAROTID ARTERY (ICA), MIDDLE CEREBRAL ARTERY (MCA), ANTERIOR CEREBRAL ARTERY (ACA), AND POSTERIOR COMMUNICATING ARTERY (PCOM) TERRITORIES, THE DISTAL TIP (MARKER BAND SEPARATION) OF A ZOOM 7X DETACHED. THE EVENT OCCURRED DURING THE THIRD PASS, WITH THE BREAK OCCURRING IN THE M1 SEGMENT. THE PHYSICIAN REPORTED ENCOUNTERING RESISTANCE WHILE ADVANCING THE ZOOM 7X THROUGH HIGHLY TORTUOUS SEGMENTS OF THE ICA AND DESCRIBED THE ANATOMY AS HAVING EXTREME TORTUOSITY. ATTEMPTS TO RETRIEVE THE DETACHED MARKER BAND WERE MADE USING A STENT RETRIEVER AND ANOTHER ZOOM 7X; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE DETACHED MARKER BAND WAS SUBSEQUENTLY PUSHED INTO THE RIGHT ANTERIOR TEMPORAL ARTERY BY A ZOOM 35 CATHETER. THE PHYSICIAN ELECTED TO LEAVE THE DETACHED MARKER BAND IN THE RIGHT ANTERIOR TEMPORAL ARTERY AS IT WAS REPORTED TO BE NON-FLOW LIMITING. POST-PROCEDURE, IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2026. THE PATIENT HAD A DO NOT RESUSCITATE/DO NOT INTUBATE (DNR/DNI) ORDER IN PLACE AND WAS SUBSEQUENTLY TRANSFERRED TO HOSPICE CARE, WHERE COMPASSIONATE EXTUBATION WAS PERFORMED. ACCOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588350 ↗
• MalfunctionMay 28, 2026Break; Material Separation; Material Deformation

  DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR A LEFT M1 OCCLUSION, THE PATIENT WAS NOTED TO HAVE A TANDEM OCCLUSION WITH 97% OCCLUSION OF THE INTERNAL CAROTID ARTERY (ICA), AS WELL AS SEVERE TORTUOSITY AND STENOSIS OF THE CERVICAL INTERNAL CAROTID ARTERY (ICA). AFTER UNSUCCESSFUL PASSES WITH TWO OTHER THIRD-PARTY CATHETERS, THE PHYSICIAN SELECTED A ZOOM 7X CATHETER. DURING THE PROCEDURE, THE THIRD-PARTY GUIDE CATHETER POSITIONED IN THE CERVICAL ICA PROLAPSED AND LOST ITS POSITION. THE PHYSICIAN SUBSEQUENTLY REMOVED THE GUIDE CATHETER AND ZOOM 7X CATHETER TOGETHER AS A SYSTEM. AFTER THE SYSTEM WAS REMOVED FROM THE PATIENT, THE TIP OF THE ZOOM 7X BECAME STUCK WITHIN THE THIRD-PARTY GUIDE CATHETER. WHILE ATTEMPTING TO REMOVE THE ZOOM 7X CATHETER FOR USE WITH ANOTHER GUIDE CATHETER, THE CATHETER SHAFT SEPARATED. THE REPORTED BREAK OCCURRED OUTSIDE THE PATIENT, AND NO INTERVENTION WAS NEEDED. THE PHYSICIAN THEN USED A ZOOM SUPPORT CATHETER AND ANOTHER ZOOM 7X TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326216 ↗
• MalfunctionMay 21, 2026Break; Material Separation

  IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR AN INTERNAL CAROTID ARTERY (ICA) TERMINUS OCCLUSION EXTENDING INTO THE DISTAL M1/PROXIMAL M2 SEGMENT, THE ZOOM 7X CATHETER SEPARATED DURING THE EIGHTH PASS WHILE BEING USED WITH A THIRD-PARTY STENT RETRIEVER. THE SEPARATION OCCURRED PROXIMAL TO THE GRAY SEGMENT OF ZOOM 7X. RESISTANCE WAS NOTED DURING RETRACTION OF THE STENT RETRIEVER. THE SEPARATED CATHETER SEGMENT WAS IDENTIFIED WITHIN THE ZOOM 88 SUPPORT CATHETER AFTER CASE COMPLETION AND REMOVAL OF THE SYSTEM FROM THE PATIENT. THE DISTAL PIECE WAS RETRIEVED BY FLUSHING THE ZOOM SUPPORT CATHETER OUTSIDE THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE. THE ANATOMY WAS DESCRIBED AS SEVERELY TORTUOUS, INCLUDING A 360-DEGREE LOOP IN THE INTERNAL CAROTID ARTERY (ICA) AND A DOUBLE S-SHAPED CONFIGURATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250178 ↗
• MalfunctionMay 13, 2026Break; Material Separation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE FOR AN M1 OCCLUSION, THE ZOOM 7X CATHETER DISTAL END SEPARATED. A TOTAL OF TWO PASSES WERE PERFORMED WITH THE DEVICE. NO REPLACEMENT DEVICE OR INTERVENTION WAS REQUIRED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DAMAGE WAS OBSERVED OUTSIDE THE PATIENT. ACCORDING TO THE PHYSICIAN, THE ISSUE MAY HAVE BEEN RELATED TO INTERACTION WITH THE ROTATING HEMOSTATIC VALVE (RHV), POTENTIALLY DUE TO OVERTIGHTENING. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161661 ↗
• MalfunctionMay 1, 2026Break; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE OF THE M2 SEGMENT, THE ZOOM 7X CATHETER WAS OBSERVED TO BE FRACTURED WITHIN THE ZOOM SUPPORT CATHETER UPON EXTRACTION OF THE ZOOM SYSTEM. ALL SEGMENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. PER THE CUSTOMER, RESISTANCE WAS NOTED DURING ADVANCEMENT AND RETRACTION OF THE CATHETER DUE TO CHALLENGING VESSEL ANATOMY. TNK WAS ADMINISTERED WHICH RESOLVED MAJORITY OF THE CLOT, RESULTING IN A SINGLE-PASS SUCCESSFUL PROCEDURE. FINAL ANGIOGRAPHIC ASSESSMENT DEMONSTRATED TICI 2B REPERFUSION, AND THE PATIENT WAS REPORTED TO BE STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057791 ↗
• InjuryMar 13, 2026Break; Material Separation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MECHANICAL THROMBECTOMY OF THE M1 SEGMENT USING ZOOM 88, ALONG WITH A THIRD PARTY ACCESS CATHETER AND SHEATH. STENOSIS OF THE CAROTID ARTERY WAS NOTED. THE PHYSICIAN ADVANCED THE ZOOM 7X OVER A ZOOM 35 AND THIRD PARTY WIRE TO THE M1 CLOT AND SUCCESSFULLY RETRIEVED THE CLOT. A REMAINING CLOT WAS IDENTIFIED IN THE M2 SEGMENT. THE PHYSICIAN THEN USED A ZOOM 35 AND A THIRD PARTY WIRE TO ADVANCE THE 7X TO THE CLOT IN THE M2. ON SECOND PASS, THE PHYSICIAN REMOVED ZOOM 7X AND NOTICED THAT THE TIP WAS MISSING AND WAS LODGED IN THE M2/M1/ICA. THE PHYSICIAN ADVANCED THE ZOOM 88 TO THE DETACHED TIP AND SUCCESSFULLY REMOVED IT BY ASPIRATING THROUGH ZOOM 88. FULL REPERFUSION OF BOTH THE M1 AND M2 SEGMENTS WAS ACHIEVED. A TOTAL OF TWO PASSES WERE COMPLETED FOR THE PROCEDURE. THE PATIENT'S POST PROCEDURE STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595784 ↗
• 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 23856014 ↗
• InjuryDec 3, 2025Break; Material Separation; Material Deformation; Break; Material Separation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN M1 OCCLUSION, SEVERE CAROTID STENOSIS AND STROKE-LIKE SYMPTOMS. THE CAROTID ARTERY STENOSIS AND THIRD-PARTY SHEATH PLACEMENT RESTRICTED THE ADVANCEMENT OF ZOOM 88 ACCESS CATHETER. ZOOM 7X NAVIGATED THROUGH SIGNIFICANT VESSEL TORTUOSITY AND A 360-DEGREE CURVATURE; THE PROCEDURE WAS COMPLETED IN A SINGLE ASPIRATION PASS. DURING RETRACTION OF THE ZOOM 7X, RESISTANCE WAS ENCOUNTERED, AND THE CATHETER TIP WAS FOUND TO BE DAMAGED UPON REMOVAL OF THE DEVICE FROM THE PATIENT. IMAGING REVEALED THAT THE CATHETER TIP REMAINED IN THE PATIENT'S M1 SEGMENT. THE PHYSICIAN THEN INTRODUCED A ZOOM 55 CATHETER THROUGH THE ZOOM 88 TO ENGAGE THE DETACHED TIP AND SUCCESSFULLY RETRIEVED THE ENTIRE SEGMENT. THE PATIENT ACHIEVED SUCCESSFUL REPERFUSION AND THERE WAS NO PATIENT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708483 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STROKE-LIKE SYMPTOMS, INCLUDING A CHRONIC OCCLUSION ON THE LEFT SIDE AND AN ACUTE STROKE ON THE RIGHT SIDE. THE PHYSICIAN INITIALLY PERFORMED TWO PASSES USING THIRD-PARTY DEVICES. AFTER THE SECOND PASS, PARTIAL OPENING OF THE M1 SEGMENT WAS OBSERVED. THE PHYSICIAN REMOVED THE DEVICES AS A SYSTEM, AND A SUBSEQUENT RUN REVEALED A BLEED AFTER THE SECOND PASS. FOR THE THIRD PASS, ZOOM 7X WAS USED OVER THE THIRD-PARTY REPERFUSION CATHETER. FOLLOWING THIRD PASS, BLEEDING WAS NOTED AT THE INTERNAL CAROTID ARTERY (ICA) M1 TERMINUS SEGMENT. AN ADDITIONAL THIRD-PARTY DEVICE WAS PLACED TO CONTROL THE BLEED. ONCE BLEEDING WAS CONTROLLED, THE M1 SEGMENT REMAINED OCCLUDED, SO THE PHYSICIAN PROCEEDED WITH FOURTH AND FIFTH PASSES USING THIRD-PARTY DEVICES WITH ASPIRATION. AFTER THE FIFTH PASS, THE PATIENT EXPERIENCED REBLEEDING, AND AN ADDITIONAL THIRD-PARTY DEVICE WAS PLACED TO CONTROL THE REBLEEDING. UPON FOLLOW-UP, THE PHYSICIAN REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2025, DUE TO THE SEVERITY OF THE ISCHEMIC STROKE, NOT A DEVICE RELATED COMPLICATION. THERE WERE NO MALFUNCTIONS NOTED WITH THE ZOOM 7X DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23653136 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED IN THE MID-CERVICAL REGION DURING A MECHANICAL THROMBECTOMY PROCEDURE. THE PATIENT PRESENTED WITH EXTREMELY TORTUOUS ANATOMY AND AN OCCLUDED SUBCLAVIAN ARTERY. DURING THE PROCEDURE, THE PATIENT BECAME AGITATED AND REQUIRED INTUBATION. FOLLOWING ASPIRATION AND CLOT REMOVAL FROM THE RIGHT M1 SEGMENT, THE ZOOM 7X WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN OBSERVED THE DISSECTION UPON RETRACTING THE ZOOM RDL GUIDE CATHETER FOR IMAGING. A THIRD-PARTY DEVICE WAS USED TO RESOLVE THE DISSECTION. THERE WERE NO DEVICE MALFUNCTIONS REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. ACCORDING TO THE PHYSICIAN, MULTIPLE FACTORS MAY HAVE CONTRIBUTED TO THE DISSECTION, INCLUDING THE USE OF A THIRD-PARTY GUIDEWIRE, THE ZOOM 7X, ZOOM RDL, OR THE EXTENSIVE PATIENT MOVEMENT NECESSITATING INTUBATION.

  Patient problems: Vascular Dissection

  MAUDE report 23432602 ↗
• MalfunctionSep 9, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A LEFT M1 MECHANICAL THROMBECTOMY WITH ZOOM 7X, A THIRD-PARTY GUIDEWIRE AND ACCESS CATHETER USING DUAL ASPIRATION. DURING REMOVAL OF THE ZOOM 7X THROUGH THE RHV, THE DISTAL PORTION OF THE ZOOM 7X CATHETER BECAME STUCK AND SEPARATED. THE PHYSICIAN REMOVED THE RHV TO RETRIEVE THE DISTAL SEGMENT OF THE ZOOM 7X. NO FURTHER INTERVENTION WAS REQUIRED, AS THE PROCEDURE WAS SUCCESSFULLY COMPLETED IN A SINGLE PASS. THERE WAS NO PATIENT SEQUELEA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009899 ↗