ZOOM™ Reperfusion Catheter ICRC035158 (UDI 00812212030207)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812212030207), received between Mar 15, 2021 and Jul 8, 2021 — classified as 2 injuries.

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.

• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH AN M3 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. ACCESS WAS OBTAINED WITH A COMPETITOR ACCESS CATHETER WITH PURCHASE IN THE HIGH CERVICAL SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). A COMPETITOR GUIDE WIRE WAS ADVANCED UNTIL IT CROSSED THE CLOT IN M3 MCA, AND THE ZOOM 35 WAS ADVANCED TO THE FACE OF THE CLOT. THE M3 MCA VESSEL SIZE WAS NOTED TO BE APPROXIMATELY 1.5MM. ONE PASS WAS PERFORMED, AND UPON REMOVAL OF THE ZOOM 35 CLOT APPEARED TO BE ON THE DISTAL TIP. ANGIOGRAM PERFORMED AFTER THE FIRST PASS INDICATED A VESSEL PERFORATION IN THE M3 MCA. THE OPERATOR BELIEVES THE PERFORATION WAS DUE TO PATIENT MOVEMENT DURING THE ASPIRATION PROCEDURE. THE CASE WAS CONCLUDED AND THE PATIENT WAS INTUBATED TO MANAGE THE BLEEDING. THE STROKE SELF-RESOLVED AND PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Perforation of Vessels

  MAUDE report 12136379 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A STROKE IN THE LEFT M1. ACCESS WAS OBTAINED THROUGH THE RIGHT RADIAL ARTERY INTO THE LEFT CERVICAL CAROTID USING A 8F BALLAST LONG SHEATH. A COMBINATION OF ARISTOTLE GUIDEWIRE, ZOOM 35 AND ZOOM 71 WAS ADVANCED TO THE CLOT. THE FIRST ATTEMPT WAS UNSUCCESSFUL, THE ARISTOTLE 24 WIRE WAS ADVANCED FURTHER TO CATHETERIZE THE M1. WHILE ADVANCING THE ARISTOTLE 24 WIRE, IT APPEARED THAT THE WIRE WAS TRAVELING OUTSIDE THE PREVIOUS PATH OF THE VESSEL. A CONTRAST INJECTION CONFIRMED THAT THE VESSEL HAD A SMALL DISSECTION. THE DISSECTION WAS OBSERVED AT LEFT MID M1. AT THIS TIME, THE 8F BALLAST WAS PARKED AT THE DISTAL LEFT CERVICAL CAROTID, ZOOM 71 AND ZOOM 35 CATHETERS WERE PARKED AT PROXIMAL M1. THE PHYSICIAN THEN TREATED THE EXTRAVASATION WITH A STENT. POST EXTRAVASATION TREATMENT, THE PHYSICIAN USED THE SAME ZOOM 71 AND ZOOM 35 COMBINATION FOR AN ADDITIONAL 2 PASSES AND WAS ABLE TO ACHIEVE REPERFUSION WITH A TICI SCORE OF 2B. THE PATIENT WAS REPORTED TO BE STABLE POST PROCEDURE. PHYSICIAN STATED THAT IT WAS INCONCLUSIVE WHAT DEVICE CONTRIBUTED TO THE DISSECTION, BUT LIKELY THE GUIDEWIRE WAS MOST INVOLVED. BOTH ZOOM 71 AND ZOOM 3

  Patient problems: Extravasation; Vascular Dissection

  MAUDE report 11486190 ↗

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