ZOOM™ Reperfusion Catheter ICRC055137Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812212030283), received between Jul 2, 2021 and May 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K202182); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2023Break; Material Separation; Break; Material Separation

  AN 83-YEAR-OLD PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE DISTAL PORTIONS OF THE M2 SEGMENT. THE PATIENT HAD A TYPE 3 ARCH, AND THE ANATOMY WAS REPORTED TO BE TORTUOUS. ACCESS WAS OBTAINED WITH A TRACSTAR ACCESS CATHETER WHICH WAS POSITIONED AT THE PETROUS CAVERNOUS OF THE INTERNAL CAROTID ARTERY (ICA). A ZOOM 55 CATHETER WAS ADVANCED THROUGH THE TRACSTAR TO THE FACE OF THE CLOT. A FIRST PASS WAS MADE WITH THE ZOOM 55 WITHOUT ANY ISSUES. FOR THE SECOND PASS, THE PHYSICIAN ADVANCED A THIRD PARTY MICROCATHETER AND STENT RETRIEVER THROUGH THE SAME ZOOM 55 TO THE CLOT. AFTER THE SECOND PASS, WHILE RETRACTING THE STENT RETRIEVER INTO THE ZOOM 55, THE DISTAL PORTION OF THE ZOOM 55 SHAFT DEFORMED AND BROKE APPROXIMATELY 12CM PROXIMAL FROM THE DISTAL END OF THE CATHETER. WITH THE STENT RETRIEVER ALREADY THROUGH THE ZOOM 55, THE PHYSICIAN SUCCESSFULLY REMOVED THE DISTAL SEGMENT OF THE ZOOM 55 AND STENT RETRIEVER TOGETHER. THE PHYSICIAN DID NOT CONTINUE WITH THE PROCEDURE. THE CLOT WAS PARTIALLY REMOVED, AND THE PATIENT ACHIEVED PARTIAL REPERFUSION WITH A TICI 2A SCORE. THE PATIENT WAS REPORTED STABLE, AND NO PATIENT SEQUELAE WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908054 ↗
• InjuryJul 2, 2021Break; Break

  PATIENT PRESENTED WITH SAGITTAL SINUS THROMBOSIS. ACCESS WAS OBTAINED WITH A ZOOM 88 ADVANCED OVER A COMPETITOR SUPPORT CATHETER AND 0.035 GUIDEWIRE IN THE TRANSVERSE SINUS. ZOOM 55 WAS SUBSEQUENTLY ADVANCED TO THE CLOT AND HOOKED UP TO THE ASPIRATION PUMP FOR MECHANICAL THROMBECTOMY. ONCE UNDER ASPIRATION, THE PHYSICIAN RAPIDLY ADVANCED AND RETRACTED THE ZOOM 55 WITHIN THE SAGITTAL SINUS FOR APPROXIMATELY 15 SECONDS. DURING THE ZOOM 55 REMOVAL IT WAS OBSERVED THAT THE MID SHAFT SEPARATED, WITH APPROXIMATELY 20CM OF DISTAL SHAFT REMAINING IN THE PATIENT. THE PHYSICIAN PROCEEDED TO REMOVE THE SEPARATED DISTAL SHAFT BY INFLATING A BALLOON CATHETER AND ANCHORING THE SEPARATED ZOOM 55 SEGMENT, AND SUBSEQUENTLY RETRACTING IT INTO THE GUIDE CATHETER. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NEW ZOOM 71. PATIENT IS CURRENTLY STABLE AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112503 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K202182. 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