Zoom Catheter ICRC045144Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00812212030498), received between Jun 29, 2023 and Dec 19, 2025 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 66-YEAR-OLD FEMALE PATIENT WAS TREATED FOR AN OCCLUSION AT THE RIGHT M1 AND M2 SEGMENT. ACCESS WAS OBTAINED USING A ZOOM 88 ACCESS CATHETER TO THE INTERNAL CAROTID ARTERY (ICA). DURING THE FIRST PASS, A ZOOM 71 ASPIRATION CATHETER AND A GUIDEWIRE WERE ADVANCED THROUGH THE ZOOM 88 TO THE FACE OF THE CLOT IN THE RIGHT M1 SEGMENT. THE GUIDEWIRE WAS THEN REMOVED, AND ASPIRATION WAS APPLIED TO THE ZOOM 71. THE RIGHT M1 SEGMENT WAS SUCCESSFULLY RECANALIZED. FOR THE SECOND PASS, THE ZOOM 88 WAS POSITIONED IN THE PETROUS SEGMENT OF THE RIGHT ICA. A ZOOM 45 ASPIRATION CATHETER, A THIRD-PARTY MICROCATHETER, AND THE GUIDEWIRE WERE ADVANCED THROUGH THE ZOOM 88 TO THE RIGHT M2 SEGMENT OCCLUSION. THE PHYSICIAN REPORTED "DRASTIC" CHANGES ON THE MONITOR, AND SOON AFTER, EXTRAVASATION WAS NOTED UNDER FLUOROSCOPY. AT THIS TIME, THE THIRD-PARTY MICROCATHETER AND THE ZOOM 45 WERE IN THE RIGHT M2 SEGMENT, AND THE GUIDEWIRE WAS JUST DISTAL TO THE ZOOM 45. ANOTHER CONTRAST RUN WAS PERFORMED AND SHOWED EXTRAVASATION AT THE RIGHT M2 SEGMENT. PROTAMINE WAS ADMINISTERED TO STOP THE BLEEDING AND THE PATIENT WAS INTUBATED. APPROXIMATELY FIVE MINUTES LATER, THE BLEEDING STOPPED. ALL DEVICES WERE REMOVED FROM

  Patient problems: Extravasation; Perforation of Vessels

  MAUDE report 20698500 ↗
• DeathJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IN-SERVICE VISIT, THE PHYSICIAN REPORTED TO THE IMPERATIVE CARE SALES REPRESENTATIVE ABOUT A VESSEL PERFORATION EVENT THAT OCCURRED "A FEW MONTHS AGO" WITH A ZOOM 45 CATHETER. THE CLOT LOCATION WAS IN THE INFERIOR DISTAL M2 SEGMENT. DURING THE FIRST PASS, THE PHYSICIAN USED A THIRD-PARTY ACCESS CATHETER AND TWO DIFFERENT SIZE ASPIRATION CATHETERS OVER A GUIDEWIRE, BUT THEY COULD NOT ADVANCE. BOTH ASPIRATION CATHETERS WERE REMOVED FROM THE PATIENT. WITH THE SAME THIRD-PARTY ACCESS CATHETER IN PLACE, THE PHYSICIAN THEN ADVANCED A ZOOM 45 CATHETER OVER A THIRD-PARTY MICROCATHETER AND GUIDEWIRE TO THE FACE OF THE CLOT IN THE M2 SEGMENT. THE MICROCATHETER AND GUIDEWIRE WERE THEN REMOVED FROM THE PATIENT. ASPIRATION WAS APPLIED TO THE ZOOM 45. THE PHYSICIAN DOES NOT KNOW IF THE CLOT WAS REMOVED. POST-ASPIRATION IMAGING REVEALED A VESSEL PERFORATION OF THE DISTAL M2 SEGMENT. THE PATIENT BECAME UNSTABLE, AND THE PHYSICIAN ENDED THE PROCEDURE. THERE WAS NO TREATMENT ADMINISTERED. THE PHYSICIAN INDICATED THAT THE PATIENT WAS ELDERLY AND HAD TORTUOUS ANATOMY WITH FRAGILE VESSELS. THE PHYSICIAN WAS NOT SURE IF THE ZOOM 45 HAD CAUSED THE VESSEL PERFORATION. NO DEVICE DEFICIENCY WAS RE

  Patient problems: Perforation of Vessels

  MAUDE report 19639452 ↗
• MalfunctionAug 16, 2023Break; Material Separation; Break; Material Separation

  AN 85-YEAR-OLD WOMAN WAS TREATED RADIALLY FOR AN OCCLUSION AT THE RIGHT M2 SEGMENT. THE TREATING PHYSICIAN PERFORMED THE EXCHANGE TECHNIQUE WITH A 6F SHEATH AND INSERTED THE ZOOM RDL. THE PHYSICIAN THEN USED A 0.035" GUIDE WIRE AND A THIRD PARTY MICROCATHETER. THE MICROCATHETER WAS ADVANCED TO THE ICA (INTERNAL CAROTID ARTERY). THE ZOOM RDL WAS ADVANCED OVER THE MICROCATHETER TO THE CCA (COMMON CAROTID ARTERY) AND LATER ADVANCED IT TO THE VERY PROXIMAL ICA. THE PHYSICIAN DID NOT GET THE ZOOM RDL VERY HIGH DUE TO RESISTANCE FELT WHILE PUSHING THE CATHETER OUT OF A TYPE C ARCH AROUND THE 180-DEGREE TURN. THE MICROCATHETER AND 0.035" WIRE WERE REMOVED OUT OF THE PATIENT. A 0.014" GUIDEWIRE, DIFFERENT THIRD PARTY MICROCATHETER, AND ZOOM 45 WERE INSERTED AND ADVANCED TO THE FACE OF THE CLOT AT M2 SEGMENT WITHOUT ISSUE. THE ZOOM RDL WAS ADVANCED A BIT HIGHER (BARELY PROXIMAL TO ICA) AND ASPIRATION WAS APPLIED TO THE ZOOM 45. WHEN THE PHYSICIAN DID NOT SEE ANY CLOT IN THE CANNISTER, THE PHYSICIAN RETRACTED THE ZOOM 45 OUT OF THE ZOOM RDL TO FLUSH THE CATHETER. THERE WAS A LOT OF RESISTANCE AND INITIALLY THE PHYSICIAN COULD NOT GET THE ZOOM 45 OUT OF THE ZOOM RDL. WHEN THE ZOOM 45 WAS REMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561184 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 63-YEAR-OLD MALE WAS TREATED FOR AN OCCLUSION AT THE M1 SEGMENT. ACCESS WAS OBTAINED WITH A ZOOM 88 ACCESS CATHETER OVER A GUIDEWIRE. A ZOOM 71 WAS ADVANCED OVER THE GUIDEWIRE TO THE FACE OF THE CLOT. THE ZOOM 88 WAS THEN ADVANCED OVER THE ZOOM 71 AND WAS POSITIONED PROXIMAL TO THE M1 SEGMENT CLOT. THE GUIDEWIRE AND ZOOM 71 WERE REMOVED FROM THE PATIENT AND ASPIRATION WAS APPLIED TO THE ZOOM 88 FOR APPROXIMATELY TWO MINUTES. SOME CLOT WAS REMOVED. AN ANGIOGRAM REVEALED RECANALIZATION WAS NOT ACHIEVED. A SECOND PASS WAS PERFORMED WITH THE SAME ZOOM 88 AND GUIDEWIRE. THE SAME ZOOM 71 WAS ADVANCED TO THE FACE OF THE CLOT. THE ZOOM 88 WAS ADVANCED OVER THE ZOOM 71 INTO THE PROXIMAL M1 SEGMENT. THE GUIDEWIRE AND ZOOM 71 WERE REMOVED FROM THE PATIENT. THE ZOOM 88 WAS CONNECTED TO THE ZOOM PUMP AND ASPIRATION WAS APPLIED FOR APPROXIMATELY TWO MINUTES. THE CLOT WAS REMOVED. AN ANGIOGRAM REVEALED RECANALIZATION OF THE M1 SEGMENT, AND A TICI 2B SCORE WAS ACHIEVED. AN ANGIOGRAM REVEALED ANOTHER OCCLUSION AT DISTAL M3 SEGMENT. A THIRD PASS WAS PERFORMED USING THE SAME GUIDEWIRE AND ZOOM 88. A ZOOM 45 WAS ADVANCED OVER THE GUIDEWIRE THROUGH THE ZOOM 88. THE ZOOM 88 WAS POSITIONED IN THE CAVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233067 ↗

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