Zoom Catheter ICRC035158Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00812212030443), received between Mar 4, 2022 and Jul 8, 2026 — classified as 1 death, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K210996, K242672); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• 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 ↗
• 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 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 61-YEAR-OLD MALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE M3 SEGMENT. ACCESS WAS OBTAINED USING A THIRD-PARTY ACCESS CATHETER, WHICH WAS PARKED AT THE CERVICAL. DURING THE FIRST PASS, A GUIDEWIRE AND A ZOOM 35 ASPIRATION CATHETER WERE ADVANCED THROUGH THE THIRD-PARTY ACCESS CATHETER TO THE FACE OF THE CLOT WITHOUT ISSUE. ASPIRATION WAS APPLIED TO THE ZOOM 35, AND THE CLOT WAS REMOVED SUCCESSFULLY. A POST-CONTRAST RUN SHOWED ADDITIONAL CLOT IN THE M4 SEGMENT. FOR THE SECOND PASS, THE SAME ZOOM 35 AND GUIDEWIRE WERE ADVANCED TO RETRIEVE THE ADDITIONAL CLOT IN THE M4 SEGMENT. WHEN ADVANCING THE ZOOM 35 TO THE CLOT, A RUPTURE WAS OBSERVED UNDER FLUOROSCOPY. THE RUPTURE WAS COILED, AND THE PROCEDURE WAS COMPLETED. A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, SHOWING MOSTLY CONTRAST. THE PATIENT WAS THEN TRANSFERRED TO COMFORT CARE. AT AN UNKNOWN LATER DATE, THE PATIENT PASSED AWAY. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS ATTRIBUTED TO MULTIPLE PRE-EXISTING COMORBIDITIES AND NOT TO THE BLEED. THERE WAS NO DEVICE MALFUNCTION REPORTED AGAINST THE ZOOM 35 CATHETER.

  Patient problems: Perforation of Vessels

  MAUDE report 20736243 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 56-YEAR-OLD FEMALE PATIENT WAS TREATED FOR AN OCCLUSION IN THE LEFT PROXIMAL M2 SEGMENT. ACCESS WAS OBTAINED USING A ZOOM 88 ACCESS CATHETER TO THE INTERNAL CAROTID ARTERY (ICA). DURING THE FIRST PASS, A ZOOM 55 ASPIRATION CATHETER AND A GUIDEWIRE WERE ADVANCED TO THE FACE OF THE CLOT IN THE LEFT MIDDLE CEREBRAL ARTERY. THE GUIDEWIRE WAS THEN ADVANCED PASS THE OCCLUSION. ZOOM 55 COULD NOT BE ADVANCED THROUGH THE CLOT. ASPIRATION WAS APPLIED TO THE ZOOM 55 FOR APPROXIMATELY 1-2 MINUTES, BUT THE CLOT WAS NOT REMOVED. AFTER A CONTRAST RUN, IMAGING SHOWED NO CHANGE IN THE OCCLUSION AT THE PROXIMAL M2 SEGMENT. THERE WAS NO INDICATION OF EXTRAVASATION. FOR THE SECOND PASS, THE ZOOM 88 REMAINED PARKED IN THE ICA AS THE SAME ZOOM 55 WAS ADVANCED OVER A ZOOM 35 ASPIRATION CATHETER AND THE GUIDEWIRE. THE GUIDEWIRE WAS AGAIN ADVANCED INTO THE M2 SEGMENT. THE ZOOM 35 WOULD NOT PASS THE OCCLUSION BUT SAT AT THE OPENING OF THE M2 SEGMENT. THE PHYSICIAN THEN ADVANCED THE ZOOM 55 INTO THE M1 SEGMENT TO PROVIDE SUPPORT TO THE ZOOM 35. WHILE ADVANCING THE ZOOM 35 , (AS THE ZOOM 55 REMAINED STATIONARY) THE ZOOM 35 AND GUIDEWIRE PROLAPSED INTO THE M1 SEGMENT. THE ZOOM 35 AND GUIDEWIRE WERE RETRACTED

  Patient problems: Extravasation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20626555 ↗
• InjuryAug 22, 2024Break; Material Separation; Break; Material Separation

  AN 84-YEAR-OLD MALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT M2 SEGMENT. THE PATIENT'S ANATOMY WAS REPORTED TO BE MILDLY TORTUOUS. ACCESS WAS OBTAINED USING THIRD-PARTY (0.096" ID ACCESS CATHETER), WHICH WAS PARKED DISTAL TO THE BIFURCATION. DURING THE FIRST PASS A THIRD-PARTY ASPIRATION CATHETER WAS ADVANCED THROUGH THE ACCESS CATHETER TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED. IMAGING SHOWED A MORE DISTAL OCCLUSION REMAINED. THE THIRD-PARTY ASPIRATION CATHETER WAS REMOVED FROM THE PATIENT. DURING THE SECOND PASS, THE PHYSICIAN ADVANCED A ZOOM 35 CATHETER OVER A GUIDEWIRE THROUGH THE THIRD-PARTY ACCESS CATHETER TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED TO THE ZOOM 35. A PARTIAL CLOT WAS REMOVED. IN THE THIRD PASS, THE SAME ZOOM 35 WAS ADVANCED THROUGH THE ACCESS CATHETER TO THE FACE OF THE CLOT AND ASPIRATION WAS APPLIED. WHILE REMOVING THE ZOOM 35, RESISTANCE WAS FELT AT AN UNKNOWN ANATOMICAL LOCATION. THE ZOOM 35 WAS REMOVED FROM THE PATIENT. IMAGING SHOWED A PARTIAL CLOT WAS REMOVED. INSPECTION OF THE REMOVED ZOOM 35 SHOWED THE OUTSIDE COATING OF THE CATHETER WAS DAMAGED. THE TYPE OF THE DAMAGE WAS NOT PROVIDED. DURING THE FOURTH PASS, A NEW ZOOM 35 WAS A

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20032657 ↗
• 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 18692029 ↗
• 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. A 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 AND

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

  MAUDE report 18315044 ↗
• MalfunctionOct 12, 2023Break; Material Separation; Break; Material Separation

  ACCESS WAS OBTAINED WITH A TRACSTAR ACCESS CATHETER OVER A GUIDEWIRE DURING AN EVALUATION OF A PATIENT WITH IIH (IDIOPATHIC INTRACRANIAL HYPERTENSION). THE TRACSTAR WAS PARKED AT THE INTERNAL JUGULAR VEIN. A ZOOM 35 WAS ADVANCED THROUGH THE TRACSTAR INTO LEFT TRANSVERSE VENOUS SINUS WITHOUT ISSUE. THE ZOOM 35 WAS THEN ADVANCED ACROSS TO THE RIGHT SIGMOID VENOUS SINUS OVER THE GUIDEWIRE. THE GUIDEWIRE WAS REMOVED AND ZOOM 35 HUB WAS CONNECTED VIA TUBING TO THE ACIST CONTRAST INJECTOR MACHINE. NO CONTRAST WAS INJECTED. THE PHYSICIAN INTENDED TO USE THE ZOOM 35 FOR DIAGNOSTIC PURPOSES; TO MEASURE THE VENOUS PRESSURE THROUGHOUT VARIOUS LOCATIONS IN THE VENOUS SINUS ANATOMY. MULTIPLE MEASUREMENTS WERE TAKEN TO LOOK FOR A LARGE CHANGE IN PRESSURES THROUGHOUT THE VENOUS SINUS ANATOMY. WHILE RETRACTING ONLY THE ZOOM 35 BACK TO THE LEFT VENOUS SINUS, THE TREATING PHYSICIAN FELT RESISTANCE. AS A RESULT, THE PHYSICIAN RETRACTED BOTH THE TRACSTAR AND ZOOM 35 TOGETHER AS A SYSTEM. THE PHYSICIAN SAW, UNDER FLUOROSCOPY, THAT THE INNER COIL OF THE ZOOM 35 HAD UNRAVELED, AND IT WAS "TRAILING" THE ZOOM 35 TIP. THE ENTIRE ZOOM 35 WAS REMOVED WITH THE TRACSTAR, AND BOTH CATHETERS WERE REMOVED TOGETHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927909 ↗
• InjuryFeb 2, 2023Break; Material Separation; Break; Material Separation

  A 93-YEAR-OLD PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE M2 SEGMENT. DURING THE FIRST PASS, ZOOM 88 ACCESS CATHETER WAS ADVANCED TO THE CAVERNOUS INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN SUCCESSFULLY NAVIGATED ZOOM 55 AND ZOOM 35 OVER A GUIDEWIRE TO THE FACE OF THE DISTAL OCCLUSION. THE PHYSICIAN REPORTED THAT WHEN SHE REMOVED THE ZOOM 35, THE DISTAL PORTION OF THE CATHETER WAS MISSING. IMAGING SHOWED THAT THE DISTAL PORTION OF THE ZOOM 35 CATHETER WAS IN THE M2 SEGMENT. ON THE SECOND PASS, THE PHYSICIAN ADVANCED A STENT RETRIEVER THROUGH THE ZOOM 55 AND THE OCCLUSION. THE STENT RETRIEVER CAPTURED THE DISTAL PART OF THE ZOOM 35 FROM THE M2 SEGMENT AND WAS REMOVED FROM THE PATIENT'S BODY. THE STENT RETRIEVER DID NOT REMOVE THE CLOT AS THERE WAS NO BACK FLOW OF BLOOD NOTED DURING ASPIRATION. THE PHYSICIAN SPECULATED THAT THE CLOT WAS VERY HARD AND CALCIFIED. SHE EXAMINED THE ZOOM 88 AFTERWARDS AND NOTED NO ISSUES WITH THE DEVICE. THE ZOOM 55 DISTAL TIP WAS OBSERVED TO BE DAMAGED (DEFORMED?). SHE REPORTED THERE WAS NO RESISTANCE FELT WHILE ADVANCING THE SYSTEM OR WHEN REMOVING THE ZOOM 35 FROM THE ZOOM 55. THE CASE WAS COMPLETED AFTER THE UNSUCCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285919 ↗
• MalfunctionApr 8, 2022Break; Material Separation; Break; Material Separation

  THE PATIENT WAS BEING TREATED FOR AN OCCLUSION AT THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT. ZOOM 35 AND ZOOM 55 WERE REMOVED FROM PACKAGING AND FLUSHED. A GUIDEWIRE WAS FLUSHED AND LOADED INTO ZOOM 35. ZOOM 35 WAS INSERTED INTO ZOOM 55, AND THE ASSEMBLY WAS PLACED IN HEPARINIZED SALINE. ACCESS WAS SUCCESSFULLY GAINED WITH ZOOM 88. WHILE ACCESS WAS BEING OBTAINED, ZOOM 35 AND ZOOM 55 ASSEMBLY WAS MOVED TO THE STERILE FIELD FOR A SHORT PERIOD OF TIME. WHEN INSERTING THE ZOOM 35 AND ZOOM 55, THE PHYSICIAN NOTED THE ASSEMBLY FELT "STICKY". THE ASSEMBLY WAS ADVANCED THROUGH THE VASCULATURE TO THE CLOT. WHEN THE PHYSICIAN TRIED TO RETRACT ZOOM 35 INTO ZOOM 55, HE FELT RESISTANCE. ADDITIONAL EFFORT WAS MADE TO PULL THE ZOOM 35. THE CATHETER FRACTURED AND PROXIMAL PORTION OF THE ZOOM 35 WAS REMOVED. THE DISTAL END OF THE ZOOM 35 WAS IN THE ZOOM 55 AND BOTH CATHETERS WERE REMOVED AS ONE UNIT. THERE WAS NO INTERVENTION REQUIRED AS THERE WAS NO FOREIGN MATERIAL LEFT IN THE BODY. THE PHYSICIAN CONTINUED THE CASE WITH A NEW ASSEMBLY OF ZOOM 71 AND ZOOM 35. THE CASE WAS SUCCESSFULLY COMPLETED WITH ONE PASS. THE PATIENT ACHIEVED TICI 3 RESULT AND NIHSS SCORE WENT FROM 17 PRE-PROCEDURE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053393 ↗
• InjuryMar 4, 2022Break; Material Separation; Break; Material Separation

  THE PATIENT WAS BEING TREATED FOR A LEFT INTERNAL CAROTID ARTERY (ICA) M1 SEGMENT OCCLUSION. ACCESS WAS OBTAINED RADIALLY WITH A COMPETITOR ACCESS CATHETER FROM THE RIGHT SIDE. THE PATIENT WAS REPORTEDLY VERY TALL. THE PHYSICIAN ATTEMPTED TO PLACE THE ACCESS CATHETER MORE DISTAL BUT DIDN'T HAVE ENOUGH LENGTH. THE ACCESS CATHETER'S HUB WAS ABUTTED TO THE WRIST. ZOOM35 AND ZOOM71 WERE ADVANCED TO THE TARGET CLOT LOCATION. ZOOM35 WAS REMOVED AND ASPIRATION WAS APPLIED. WHEN THE PHYSICIAN TRIED TO RETRACT ZOOM71, THE PHYSICIAN NOTICED THAT THERE WAS NO ONE-TO-ONE MOVEMENT. AT THIS TIME THE ACCESS CATHETER WAS NOT OBSERVED ON THE IMAGING SCREEN AND WAS OUT OF THE ICA. THE PHYSICIAN BELIEVED THAT THE ZOOM71 HAD "DOUBLED BACK" ON ITSELF, AND THAT CATHETER SEPARATED UPON RETRACTION INTO THE ACCESS CATHETER. CATHETER WAS REMOVED SUCCESSFULLY WITH A 1.5CM SNARE. THE CASE WAS COMPLETED AFTER ONE PASS AND TICI 3 WAS ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13670846 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210996, K242672. One submission often covers many models, so check the product and lot details in each record.

• Z-2577-2021 · Aug 13, 2021 · Completed
  Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurova