Zoom Catheter ICRC055137Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00812212030474), received between Feb 21, 2023 and Sep 28, 2026 — classified as 3 deaths, 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K202182, 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 23 most recent of 23 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 22, 2025Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT A VERY DISTAL LOCATION (EXACT LOCATION OF THE CLOT NOT PROVIDED). THE PATIENT REPORTEDLY HAD A TORTUOUS ANATOMY. ACCESS WAS OBTAINED WITH ZOOM 88 WHICH WAS PARKED AT THE DISTAL ICA/TERMINUS. THE ZOOM 55 WAS INITIALLY TRACKED ONLY OVER A .016" GUIDEWIRE WITHOUT ANOTHER CATHETER INSIDE IT FOR SUPPORT. RESISTANCE WAS FELT WHEN ADVANCING THE ZOOM 55 OVER THE WIRE. THE PHYSICIAN BELIEVED THE ZOOM 55 MIGHT HAVE BEEN TOO LARGE FOR THE TARGET VESSEL AND THOUGHT ABOUT SWITCHING TO A ZOOM 45. INSTEAD, HE DECIDED TO PERFORM TWO PASSES WITH THE ZOOM 55 WITHOUT PERFORMING ASPIRATION. ON THE 3RD PASS, A ZOOM 35 WAS INTRODUCED INSIDE OF ZOOM 55 TO MAKE ZOOM 55 TRACK MORE DISTALLY. MORE RESISTANCE WAS FELT WHEN ZOOM 35 WAS INTRODUCED INSIDE OF ZOOM 55. THE PHYSICIAN REMOVED BOTH ZOOM 55 AND ZOOM 35 AS A SYSTEM. WHEN THE ZOOM 35 WAS REMOVED FROM ZOOM 55 OUTSIDE THE PATIENT, THE TIP OF THE ZOOM 55 INVERTED/ACCORDIONED ON ITSELF. OUTSIDE OF THE PATIENT, WHEN THE PHYSICIAN TRIED TO MANUALLY STRAIGHTEN THE TIP OF THE ZOOM 55, IT BROKE SEVERAL CENTIMETERS BACK FROM THE DISTAL TIP. A ZOOM 45 WAS THEN USED TO COMPLETE THE PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21671618 ↗
• InjuryNov 6, 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 20623385 ↗
• DeathAug 18, 2024Break; Material Separation; Break; Material Separation

  A 67-YEAR-OLD FEMALE PATIENT WAS TREATED FOR AN OCCLUSION IN THE LEFT M2 SEGMENT. THE PATIENT WAS REPORTED TO HAVE ATHEROSCLEROTIC DISEASE WITH AN ACUTE BEND IN CERVICAL INTERNAL CAROTID ARTERY (ICA) AND HAIRPIN BEND BEYOND CAROTID BULB. ACCESS WAS OBTAINED WITH AN ARISTOTLE GUIDEWIRE AND A ZOOM 88 TO THE DISTAL PETROUS. THE PHYSICIAN INDICATED THAT ADVANCING THE ZOOM 88 OVER THE STIFF GUIDEWIRE WAS "TRICKY". DURING THE FIRST PASS, A ZOOM 55 CATHETER WAS ADVANCED THROUGH THE ZOOM 88 TO THE FACE OF THE CLOT. THE TREATING PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE WHILE ADVANCING THE ZOOM 55 THROUGH THE ZOOM 88. ASPIRATION WAS APPLIED TO THE ZOOM 55, AND THE CLOT WAS REMOVED FROM THE M2 SEGMENT, ACHIEVING A TICI 3 SCORE. THE ZOOM 88 WAS RETRACTED INTO THE COMMON CAROTID WITH THE ZOOM 55 INSIDE IT. THERE WAS RESISTANCE RETRACTING THE ZOOM 55 THROUGH THE ZOOM 88. AFTER THE ZOOM 55 WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE DISTAL 10MM OF THE CATHETER WAS BROKEN. THE PHYSICIAN ALSO NOTED THERE WAS NO CLOT OBSERVED IN THE FILTER (ZOOM POD). THE PHYSICIAN BELIEVED THAT THE DISTAL SEGMENT OF THE ZOOM 55 AND CLOT WERE STILL INSIDE THE ZOOM 88. A CONTRAST RUN WAS THEN PERFORMED.

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

  MAUDE report 19999346 ↗
• DeathJul 30, 2024

  DURING MECHANICAL THROMBECTOMY FOR ACUTE STROKE, THE DISTAL TIP OF ZOOM 55 CATHETER TIP SEPARATED. AFTER SUCCESSFUL RECANALIZATION, IT APPEARED THAT THE CATHETER TIP WAS RETAINED IN THE THROMBOSIS AND ULTIMATELY MIGRATED; RESULTED IN M1 OCCLUSION. MANY ATTEMPTS TO RETRIEVE CATHETER TIP WITH A VARIETY OF STRATEGIES WERE UNSUCCESSFUL. AN ARISTOTLE 24 GUIDEWIRE USED TO TRY TO OBTAIN THE BROKEN TIP ALSO FRACTURED AND CONTRIBUTED TO THE OCCLUSION. OCCLUSION COULD NOT BE CLEARED.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 19876023 ↗
• MalfunctionJun 14, 2024Break; Material Separation; Material Deformation; Break; Material Separation; Material Deformation

  A PATIENT WAS TREATED FOR AN OCCLUSION IN THE M1 SEGMENT. THE PATIENT HAD A TYPE 1 ARCH, AND THE ANATOMY WAS NOT TORTUOUS. ACCESS WAS OBTAINED WITH A GUIDEWIRE AND A ZOOM 88 ACCESS CATHETER TO THE DISTAL PETROUS. DURING THE FIRST PASS, A ZOOM 55 CATHETER WAS ADVANCED THROUGH THE ZOOM 88 TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED, AND THE CLOT WAS REMOVED SUCCESSFULLY. POST ASPIRATION IMAGING REVEALED ANOTHER CLOT IN THE M2 SEGMENT. FOR THE SECOND PASS, THE SAME ZOOM 88 WAS ADVANCED AND PARKED IN THE PROXIMAL CAVERNOUS. THE SAME ZOOM 55 WAS ADVANCED THROUGH THE ZOOM 88 TO THE FACE OF THE CLOT IN THE M2 SEGMENT. ASPIRATION WAS APPLIED BUT UNABLE TO ASPIRATE THE CLOT SUCCESSFULLY. A ZOOM 35 CATHETER WAS THEN ADVANCED THROUGH ZOOM 55. RESISTANCE WAS FELT WHEN ADVANCING THE ZOOM 35 THROUGH ZOOM 55. THE PHYSICIAN THEN NOTICED UNDER IMAGING THAT THE ZOOM 35 AND THE ZOOM 55 WERE NOT MOVING INDEPENDENTLY. THE ZOOM 55, ZOOM 35, AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SYSTEM. PER THE PHYSICIAN, THE DISTAL END AND THE SOFT PART OF THE ZOOM 55 WAS "ALL BUNCHED-UP". AFTER REMOVAL FROM THE PATIENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE ZOOM 35 FROM INSIDE OF THE ZOOM 55 AND FOUND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536695 ↗
• InjuryApr 19, 2024Adverse 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 LEFT INFERIOR DIVISION M2 SEGMENT. ACCESS WAS OBTAINED WITH A ZOOM 88 GUIDE CATHETER OVER A GLIDEWIRE. THE ZOOM 88 WAS POSITIONED IN THE PROXIMAL CERVICAL INTERNAL CAROTID ARTERY (ICA) AND THE GLIDEWIRE WAS REMOVED. A GUIDEWIRE, THIRD-PARTY MICROCATHETER, AND A ZOOM 55 ASPIRATION CATHETER WERE ADVANCED TO THE FACE OF THE CLOT. THE MICROCATHETER AND GUIDEWIRE WERE THEN REMOVED, AND MANUAL ASPIRATION WAS APPLIED TO THE ZOOM 55. ANGIOGRAPHY WAS PERFORMED, AND NO SIGNIFICANT CHANGE WAS OBSERVED. DURING THE SECOND PASS, THE TREATING PHYSICIAN REMOVED THE ZOOM 55 AND ADVANCED A ZOOM 71 AND APPLIED MANUAL ASPIRATION USING THE SAME PROCESS AS IN THE FIRST PASS. ANGIOGRAPHY WAS REPEATED AND EVIDENCE OF STENOSIS/DISSECTION WAS OBSERVED IN THE SUPERIOR M2 SEGMENT, WHICH THE PHYSICIAN ATTRIBUTED TO CATHETER AGITATION. FOR THE THIRD PASS, THE ZOOM 71 WAS REMOVED, AND THE SAME ZOOM 55 WAS ADVANCED OVER THE SAME GUIDEWIRE. A NEW THIRD-PARTY MICROCATHETER AND A STENT RETRIEVER WERE THEN ADVANCED TO THE FACE OF THE CLOT. ASPIRATION WAS APPLIED TO THE ZOOM 55. ANGIOGRAPHY SHOWED THE OCCLUSION HAD WORSENED AND WAS NOW DO

  Patient problems: Vascular Dissection

  MAUDE report 19148568 ↗
• MalfunctionFeb 16, 2024Break; Material Separation; Break; Material Separation

  INITIAL ACCESS WAS OBTAINED RADIALLY WITH A ZOOM RDL. THE TREATING PHYSICIAN ATTEMPTED TO INSERT A ZOOM 55 BUT WAS UNSUCCESSFUL. THE PHYSICIAN BELIEVED THERE WAS A KINK, POSSIBLY AT THE DISTAL THIRD ON THE ZOOM RDL. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND THERE WAS NO ABNORMAL INTERACTION OR RESISTANCE BETWEEN THE CATHETERS PRIOR TO NOTICING THE KINK. BOTH THE ZOOM RDL AND THE ZOOM 55 WERE REMOVED FROM THE PATIENT. AFTER REMOVAL, THE PHYSICIAN REPORTED NOTICING A KINK ON BOTH ZOOM 55 AND ZOOM RDL AND BELIEVES THE KINK ON THE ZOOM RDL CAUSED THE ZOOM 55 TO KINK. THE LOCATION OF THE KINK ON THE ZOOM 55 IS UNKNOWN. THE PHYSICIAN ABORTED THE RADIAL APPROACH AND PROCEEDED WITH A FEMORAL APPROACH. FEMORAL ACCESS WAS OBTAINED WITH A ZOOM 88 CATHETER. AFTER INSERTING A NEW ZOOM 55 INTO THE PATIENT, THE TREATING PHYSICIAN REPORTED THAT THE ZOOM 55 RADIOPAQUE (RO) MARKER WAS NOT VISIBLE UNDER FLUOROSCOPY. THE PHYSICIAN REMOVED THE ZOOM 55 FROM THE PATIENT, EXAMINED IT UNDER FLUOROSCOPY, AND REPORTED THAT THE RO MARKER WAS NOT VISIBLE ON THE ZOOM 55. NO RO MARKER WAS FOUND INSIDE THE PATIENT. IT IS UNCLEAR WHETHER THERE WAS ANY RESISTANCE DURING INTRODUCTION OR REMOVAL OF THE ZOOM 55. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727436 ↗
• InjuryFeb 16, 2024Component Missing; Component Missing

  INITIAL ACCESS WAS OBTAINED RADIALLY WITH A ZOOM RDL. THE TREATING PHYSICIAN ATTEMPTED TO INSERT A ZOOM 55 BUT WAS UNSUCCESSFUL. THE PHYSICIAN BELIEVED THERE WAS A KINK, POSSIBLY AT THE DISTAL THIRD ON THE ZOOM RDL. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND THERE WAS NO ABNORMAL INTERACTION OR RESISTANCE BETWEEN THE CATHETERS PRIOR TO NOTICING THE KINK. BOTH THE ZOOM RDL AND THE ZOOM 55 WERE REMOVED FROM THE PATIENT. AFTER REMOVAL, THE PHYSICIAN REPORTED NOTICING A KINK ON BOTH ZOOM 55 AND ZOOM RDL AND BELIEVES THE KINK ON THE ZOOM RDL CAUSED THE ZOOM 55 TO KINK. THE LOCATION OF THE KINK ON THE ZOOM 55 IS UNKNOWN. THE PHYSICIAN ABORTED THE RADIAL APPROACH AND PROCEEDED WITH A FEMORAL APPROACH. FEMORAL ACCESS WAS OBTAINED WITH A ZOOM 88 CATHETER. AFTER INSERTING A NEW ZOOM 55 INTO THE PATIENT, THE TREATING PHYSICIAN REPORTED THAT THE ZOOM 55 RADIOPAQUE (RO) MARKER WAS NOT VISIBLE UNDER FLUOROSCOPY. THE PHYSICIAN REMOVED THE ZOOM 55 FROM THE PATIENT, EXAMINED IT UNDER FLUOROSCOPY, AND REPORTED THAT THE RO MARKER WAS NOT VISIBLE ON THE ZOOM 55. NO RO MARKER WAS FOUND INSIDE THE PATIENT. IT IS UNCLEAR WHETHER THERE WAS ANY RESISTANCE DURING INTRODUCTION OR REMOVAL OF THE ZOOM 55. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727435 ↗
• MalfunctionFeb 13, 2024Unraveled Material; Unraveled Material

  A 61-YEAR-OLD FEMALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT MIDDLE CEREBRAL ARTERY. THE PATIENT WAS DESCRIBED AS HAVING AN ARCH TYPE THAT INCLUDED A 120-DEGREE TURN AND WAS EXTREMELY TORTUOUS AT THE CERVICAL REGION, CLOSE TO THE ORIGIN OF THE INTERNAL CAROTID. ACCESS WAS OBTAINED WITH A ZOOM 88 ACCESS CATHETER, A ZOOM 55 ASPIRATION CATHETER, AND A STENT RETRIEVER. DURING THE FIRST PASS, THE ZOOM 88 WAS PARKED IN THE CAVERNOUS, DISTAL TO THE INTERNAL CAROTID ARTERY. THE ZOOM 55 AND STENT RETRIEVER WERE ADVANCED TO THE CLOT WITHOUT ENCOUNTERING ANY RESISTANCE. AFTER CAPTURING SOME OF THE CLOT WITH THE STENT RETRIEVER, ASPIRATION WAS APPLIED TO THE ZOOM 55. BOTH THE STENT RETRIEVER AND ZOOM 55 WERE THEN RETRACTED THROUGH THE ZOOM 88 AND REMOVED FROM THE PATIENT. NO ISSUES WERE REPORTED DURING THE FIRST PASS. ON THE SECOND PASS, THE SAME ZOOM 55 AND STENT RETRIEVER WERE USED AND WERE ABLE TO PARTIALLY ENGAGE WITH THE CLOT. ASPIRATION WAS AGAIN APPLIED TO THE ZOOM 55. THEN ZOOM 55 AND STENT RETRIEVER WERE RETRACTED THROUGH THE ZOOM 88 AND REMOVED FROM THE PATIENT. WHILE CLEANING THE ZOOM 55 AT THE BACK TABLE, THE TECHNICIAN NOTICED THAT THE TIP HAD UNRAVELED BUT WAS STILL ATTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18700238 ↗
• 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 18692065 ↗
• InjuryJan 25, 2024Material Separation; Stretched; Material Separation; Stretched

  DURING A STROKE CASE, THE TREATING PHYSICIAN USED A ZOOM 88, ZOOM 55, ZOOM 35, AND THIRD PARTY STENT RETRIEVER. IT WAS REPORTED THAT AFTER PERFORMING SIX PASSES, THE DISTAL SEGMENT OF THE ZOOM 55 WAS STRETCHED AND SEPARATED FROM THE REST OF THE CATHETER BUT HELD TOGETHER BY THE COIL. THE PHYSICIAN RETRIEVED THE ENTIRE ZOOM 55 CATHETER, INCLUDING THE SEPARATED PORTION. THE PATIENT WAS REPORTED TO BE STABLE, AND NO PATIENT SEQUELAE WERE REPORTED. SEVERAL ATTEMPTS WERE MADE TO HAVE THE TREATING PHYSICIAN PROVIDE FURTHER DETAILS OF THIS EVENT; HOWEVER, THEY WERE UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585045 ↗
• 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 18315043 ↗
• InjuryNov 7, 2023Break; Material Separation; Break; Material Separation

  A 61-YEAR-OLD MALE WAS TREATED FOR ACUTE ISCHEMIC STROKE CAUSED BY AN OCCLUSION IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PATIENT WAS DESCRIBED AS HAVING A TYPE 1-2 ARCH, SUPRACLINOID ICA STENOSIS AND A LARGE, DENSE/HARD THROMBUS IN THE M1 SEGMENT. ACCESS WAS OBTAINED WITH A THIRD-PARTY ACCESS CATHETER AND A ZOOM 55 ASPIRATION CATHETER. THE ACCESS CATHETER WAS POSITIONED HIGHER THAN THE BIFURCATION IN THE DISTAL CERVICAL AREA ON THE INITIAL ASCENT. NO RESISTANCE WAS FELT DURING ADVANCEMENT OF THE ZOOM 55, AND THE CATHETER WENT IN SMOOTHLY TO THE STENOSIS. THE PHYSICIAN ATTEMPTED TO PUSH THROUGH THE STENOSIS BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO PERFORM A BALLOON ANGIOPLASTY AT THE LOCATION OF THE STENOSIS. DURING THE RETRACTION OF THE ZOOM 55 AFTER THE BALLOON ANGIOPLASTY, THE PHYSICIAN NOTED THAT RESISTANCE WAS FELT IN THE BEGINNING, AND IT BECAME INCREASINGLY DIFFICULT TO RETRACT THE CATHETER. AFTER RETRACTING THE ZOOM 55 CATHETER, THE PHYSICIAN HEARD AN AUDIBLE SNAP AND NOTICED THAT THE DISTAL PART OF THE CATHETER REMAINED STATIONARY WHILE MOVING THE PROXIMAL PART OF THE CATHETER. AT THIS POINT, THE PHYSICIAN DID NOT OBSERVE THE THIRD-PARTY ACCESS CATHETER MO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089082 ↗
• InjuryOct 24, 2023Break; Material Separation; Break; Material Separation

  REFER TO H10 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000184 ↗
• InjuryOct 10, 2023Break; Material Separation; Break; Material Separation

  A FEMALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE M2 SEGMENT. THE PATIENT WAS NOTED TO HAVE A "TORTUOUS NECK". ACCESS WAS OBTAINED USING A GUIDEWIRE AND A ZOOM 88 ACCESS CATHETER. DURING THE FIRST PASS, A ZOOM 55 CATHETER WAS ADVANCED THROUGH THE ACCESS CATHETER AND OVER A ZOOM 35 TO THE FACE OF THE CLOT. THE ZOOM 35 AND GUIDEWIRE WERE REMOVED. ASPIRATION WAS APPLIED TO THE ZOOM 55 FOR APPROXIMATELY 90 SECONDS. RESISTANCE WAS FELT WHILE RETRACTING THE ZOOM 55 THROUGH THE ZOOM 88, WHICH WAS POSITIONED IN THE PETROUS. BOTH THE ZOOM 55 AND ZOOM 88 CATHETERS WERE REMOVED FROM THE PATIENT AS A SYSTEM. THE PHYSICIAN THEN OBSERVED (UNDER IMAGING) THE TIP OF THE ZOOM 55 IN THE A2 SEGMENT. USING THE SAME GUIDEWIRE AND ZOOM 88, THE PHYSICIAN ATTEMPTED TO ADVANCE TWO STENT RETRIEVERS THROUGH THE ACCESS CATHETER TO TRY AND CAPTURE THE SEPARATED ZOOM 55 TIP. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, BOTH STENT RETRIEVERS WERE REMOVED. A NEW ZOOM 55 CATHETER WAS SUCCESSFULLY USED TO RETRIEVE THE SEPARATED SEGMENT AND THE SECOND ZOOM 55 CATHETER WAS THEN REMOVED FROM THE PATIENT. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING A ZOOM 71 AND THE SAME ZOOM 35, GUIDEWIRE, AND ZOOM 88, WITHOUT ANY IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908478 ↗
• InjurySep 13, 2023Break; Material Separation; Break; Material Separation

  ON (B)(6) 2023, A PATIENT WAS TREATED FOR AN OCCLUSION IN THE RIGHT MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS TRANSRADIALLY PERFORMED DUE TO CHRONIC OCCLUSION OF BOTH FEMORAL ARTERIES. ACCESS WAS OBTAINED WITH A GUIDEWIRE, A THIRD-PARTY ACCESS CATHETER, A THIRD-PARTY MICROCATHETER, AND A THIRD-PARTY ASPIRATION CATHETER THROUGH THE RIGHT RADIAL ARTERY. THE PHYSICIAN NOTED THAT A TIGHT CURVE IN THE RIGHT SUBCLAVIAN ARTERY RESULTED IN SIGNIFICANT KINKING OF THE THIRD-PARTY ACCESS CATHETER. DURING THE FIRST PASS, THE THIRD-PARTY ASPIRATION CATHETER AND MICROCATHETER WERE ADVANCED TO THE FACE OF THE CLOT, AND ASPIRATION WAS APPLIED. UPON REMOVAL OF THE ASPIRATION CATHETER AND MICROCATHETER, IT WAS OBSERVED THAT THE ASPIRATION CATHETER HAD BECOME STRETCHED. IN THE SECOND PASS, THE GUIDEWIRE, A ZOOM 35, AND A ZOOM 55 WERE ADVANCED THROUGH THE SAME THIRD-PARTY ACCESS CATHETER TO THE DISTAL M1/ PROXIMAL M2 SEGMENT WITHOUT ISSUE. THE ZOOM 35 AND GUIDEWIRE WERE REMOVED, AND ASPIRATION WAS APPLIED TO THE ZOOM 55. DURING RETRACTION OF THE ZOOM 55 FROM THE PATIENT, THE PHYSICIAN ENCOUNTERED WHAT WAS DESCRIBED AS "SUBSTANTIAL RESISTANCE". IT WAS REPORTED THAT THE DISTAL MARKER BAND ON THE ZOOM 55

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

  MAUDE report 17739716 ↗
• MalfunctionJun 22, 2023Break; Material Separation; Break; Material Separation

  A PATIENT WAS TREATED FOR AN OCCLUSION AT THE LEFT M2 SEGMENT. THE PATIENT REPORTEDLY HAD A PRE-EXISTING DISSECTION. ACCESS WAS OBTAINED WITH A ZOOM 88 ACCESS CATHETER OVER A GUIDEWIRE. A ZOOM 55 AND A THIRD PARTY MICROCATHETER WERE ADVANCED OVER THE GUIDEWIRE THROUGH THE ZOOM 88. WHILE ATTEMPTING TO PERFORM THE FIRST PASS, THE TREATING PHYSICIAN NOTICED A TIGHT TURN IN THE HORIZONTAL CAVERNOUS CAUSING THE ZOOM 88 TO PRESS INTO THE SIDE OF THE ZOOM 55. WHEN THE PHYSICIAN TRIED TO REMOVE THE ZOOM 55, THE PHYSICIAN IMMEDIATELY FELT RESISTANCE. THE PATIENT WAS NOTED TO HAVE A TORTUOUS ANATOMY. AFTER REMOVING THE ZOOM 55 COMPLETELY THROUGH THE ZOOM 88 ACCESS CATHETER AND OUT FROM THE PATIENT, THE PHYSICIAN FOUND THE OUTER JACKET OF THE ZOOM 55 HAD SEPARATED HOWEVER WAS CONNECTED VIA THE COIL. THE PHYSICIAN RELEASED SOME TENSION OFF THE ZOOM 88 AND PROCEEDED WITH THE CASE USING A ZOOM 71, THIRD PARTY MICROCATHETER, AND STENT RETRIEVER SUCCESSFULLY THROUGH THE ZOOM 88. THE CLOT WAS REMOVED SUCCESSFULLY. THE PATIENT ACHIEVED PARTIAL REPERFUSION WITH A TICI 2C SCORE AND THE PATIENT WAS REPORTED STABLE. NO PATIENT SEQUELAE WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187286 ↗
• DeathMay 12, 2023Break; Material Separation; Break; Material Separation

  88-YEAR-OLD FEMALE WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION AT THE LEFT M2 SEGMENT. ACCESS WAS OBTAINED USING A GUIDEWIRE AND A ZOOM 88 ACCESS CATHETER. THE PATIENT HAD A TORTUOUS LEFT COMMON CAROTID WITH A BIG LOOP. THE ZOOM 88 WAS ADVANCED OVER THE GUIDEWIRE TO THE HIGH CERVICAL SECTION OF THE INTERNAL CAROTID ARTERY (ICA) THROUGH A TIGHT BEND IN THE COMMON CAROTID ARTERY. THE GUIDEWIRE WAS REMOVED AND EXCHANGED WITH A MICROWIRE. A ZOOM 55 WAS INSERTED INTO THE ZOOM 88 OVER A THIRD-PARTY MICROCATHETER AND MICROWIRE. IT WAS NOTED DURING INSERTION THAT THE ZOOM 88 HAD A KINK AND TENSION/RESISTANCE WAS FELT. THE ZOOM 55, THIRD PARTY MICROCATHETER, AND A STENT RETRIEVER WERE NAVIGATED TO THE CLOT OVER THE MICROWIRE. THE STENT RETRIEVER WAS PLACED THROUGH THE MICROCATHETER, AND THE MICROCATHETER WAS REMOVED. AFTER APPROXIMATELY A THREE-MINUTE DWELL TIME, THE STENT RETRIEVER WAS PARTIALLY PULLED INTO THE ZOOM 55. WHILE RETRACTING THE STENT RETRIEVER AND ZOOM 55 THROUGH THE KINKED ZOOM 88, THE PHYSICIAN FELT RESISTANCE AND BELIEVES THAT THIS IS WHERE THE DISTAL END OF THE ZOOM 55 SEPARATED FROM THE CATHETER. IMAGING WAS COMPLETED AND SHOWED THE DISTAL END OF THE ZOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921001 ↗
• InjuryFeb 21, 2023Break; Break

  AN 82-YEAR-OLD FEMALE WAS TREATED FOR AN OCCLUSION AT THE M1/M2 SEGMENT. ACCESS WAS OBTAINED WITH A COMPETITOR GUIDE CATHETER AND WAS PARKED AT THE MID-CERVICAL INTERNAL CAROTID ARTERY (ICA). AFTER NOTICING A BEND IN THE MID-CERVICAL, THE PHYSICIAN DID NOT ATTEMPT TO ADVANCE THE GUIDE CATHETER FURTHER. DURING FIRST PASS, THE PHYSICIAN ADVANCED A COMPETITOR ASPIRATION CATHETER AND A STENT RETRIEVER THROUGH THE GUIDE CATHETER, OPENING THE M1 SEGMENT. THE PHYSICIAN THEN REMOVED THE ASPIRATION CATHETER AND STENT RETRIEVER. IN THE SECOND PASS, THE PHYSICIAN ADVANCED A ZOOM 55 ASPIRATION CATHETER OVER A ZOOM 35 ASPIRATION CATHETER TO THE FACE OF THE CLOT AT THE M2 SEGMENT. WHILE PLACING THE ZOOM 35 CATHETER AT THE M2 BRANCH, THE PHYSICIAN FELT RESISTANCE BUT INDICATED IT WAS NOTHING OUT OF THE ORDINARY. THE ZOOM 35 CATHETER WAS REMOVED PRIOR TO ASPIRATION IN M2. ASPIRATION STARTED AND DURING REMOVAL OF THE ZOOM 55, THE PHYSICIAN BELIEVED THE CATHETER SHAFT BROKE AS THERE WAS NO TIP MOVEMENT NOTED. A SNARE WAS USED TO SUCCESSFULLY CAPTURE AND REMOVE THE SEPARATED ZOOM 55 PIECE FROM THE PATIENT. A REPLACEMENT ZOOM 55 CATHETER WAS USED TO SUCCESSFULLY REMOVE THE CLOT AND COMPLETE THE PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414815 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K202182, 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