ZOOM™ 88-T Large Distal Platform ICTC088110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812212030177), received between Nov 12, 2020 and Feb 10, 2022 — classified as 1 death, 1 injury, 1 malfunction.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING AN EMERGENT INTRACRANIAL MECHANICAL THROMBECTOMY FOR A LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 LARGE VESSEL OCCLUSION. THE ZOOM 088 CATHETER WAS PLACED INTO THE LEFT MCA M1 SEGMENT OVER THE ZOOM 071 ASPIRATION CATHETER, 027 MICROCATHETER AND 014 GUIDEWIRE. ASPIRATION CATHETER, MICROCATHETER AND GUIDE WIRE WERE WITHDRAWN. CATHETER WAS CONNECTED TO THE ASPIRATION TUBING AND MECHANICAL ASPIRATION WAS PERFORMED AND WITHDRAWN INTO THE CERVICAL ICA. FOLLOW UP ANGIOGRAM SHOWED THE ICA WAS OCCLUDED. A SECOND ATTEMPT WAS MADE USING A 4 X40 STENT RETRIEVER AND ZOOM 71 ASPIRATION CATHETER AND SOME CLOT WAS REMOVED. FOLLOW UP RUNS SHOWED INTIMAL DISSECTION IN THE PROXIMAL LEFT MCA M1 SEGMENT. THE PATIENT RECEIVED A BOLUS OF INTEGRILIN AND WAS PLACED ON A DRIP TO PREVENT THROMBUS AT THE DISSECTION SITE. THIS WAS FOLLOWED BY INTRACRANIAL ANGIOPLASTY. THE PATIENT ALSO RECEIVED A LARGE DOSE OF TICAGRELOR TO PREVENT THROMBUS. PRIOR TO THE PROCEDURE THE PATIENT HAD RECEIVED TENECTEPLASE. THE PATIENT'S HOSPITALIZATION WAS REPORTEDLY PROLONGED AND THE PATIENT REQUIRED PROLONGED ANTIPLATELET THERAPY TO TREAT THIS DISSECTION. PER THE TREATING PHYSICIAN, THE DISSECTION WAS LIKELY

  Patient problems: Vascular Dissection

  MAUDE report 13510394 ↗
• MalfunctionNov 26, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON (B)(3) TO TREAT OCCLUSION WITHIN THE MID BASILAR ARTERY. PATIENT DISPLAYED UNDERLYING ATHEROSCLEROSIS AT THE OCCLUSION SITE. ACCESS WAS OBTAINED AT THE DISTAL VERTEBRAL ARTERY USING THE ZOOM 88T 110CM, WHICH WAS ADVANCED OVER A COMPETITOR ANGIOGRAPHIC CATHETER AND A 035 GUIDEWIRE. ZOOM 71 REPERFUSION CATHETER WAS SUBSEQUENTLY ADVANCED UNSUPPORTED TO THE SITE OF THE OCCLUSION AND SOME CLOT WAS REMOVED THROUGH THE ZOOM 71 CATHETER. A TOTAL OF TWO PASSES WERE PERFORMED. ZOOM 71 WAS PULLED INTO ZOOM 88 (TIP STILL INTACT) WITH RESISTANCE SEEN ON WITHDRAWAL. THE TIP SEPARATED INSIDE ZOOM 88 BUT WAS NOT NOTICED BY THE PHYSICIAN. COMPETITOR DEVICES WERE USED TO RETRIEVE MORE CLOT AND PHYSICIAN SAW THE TIP IN THE VERTEBRAL ARTERY. TIP WAS REMOVED USING STENT RETRIEVER AND COMPETITOR INTERMEDIATE CATHETER. THE PHYSICIAN PROCEEDED TO PERFORM ANGIOPLASTY TO ADDRESS THE MID BASILAR ATHEROSCLEROSIS WITH NO FURTHER ISSUES. THE CASE WAS COMPLETED WITH NO ADDITIONAL CLINICAL EVENT. PATIENT WAS NOTED TO BE STABLE POST OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10909455 ↗
• DeathNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON (B)(6) TO TREAT OCCLUSION WITHIN THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS. PATIENT HAD A FETAL POSTERIOR COMMUNICATING (PCOM) ARTERY PRESENT. THE ZOOM 088T 110CM CATHETER WAS DELIVERED TO THE OSTIUM OF THE FETAL PCOM. A TOTAL OF THREE PASSES WERE PERFORMED. THE FIRST TWO PASSES WERE MADE WITH ASPIRATION USING THE ZOOM 71 REPERFUSION CATHETER WHICH HAD ADVANCED TO THE MCA OVER A COMPETITOR MICROCATHETER AND GUIDEWIRE. THE MCA LOOKED IRREGULAR PRIOR TO THE THIRD PASS. THE THIRD PASS WAS PERFORMED WITH A COMPETITOR STENT RETRIEVER. UPON FINAL IMAGING RUN A DISSECTION WAS NOTED IN THE MIDDLE CEREBRAL ARTERY (MCA) AS WELL THE ICA. AT THE TIME OF THROMBECTOMY NO INTERVENTIONS OR FOLLOW UP TREATMENTS WERE SCHEDULED FOR THE PATIENT. IT IS NOT KNOWN IF THE ZOOM CATHETERS CAUSED OR CONTRIBUTED TO THE VESSEL DISSECTIONS. PATIENT EXPIRED THREE POST OPERATIVE DAYS ON (B)(6), AND THE RELATIONSHIP BETWEEN THE VESSEL DISSECTION AND THE PATIENT DEATH IS UNKNOWN. THE CAUSE OF PATIENT DEATH IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 10833253 ↗