ZOOM™ Reperfusion Catheter ICRC045144Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812212030276), received between May 12, 2022 and May 26, 2023 — classified as 3 injuries.

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

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

• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 60-YEAR-OLD MALE WAS TREATED FOR AN OCCLUSION THAT EXTENDED FROM THE BASILAR ARTERY TO THE LEFT POSTERIOR CEREBRAL ARTERY (PCA). ACCESS WAS OBTAINED WITH A ZOOM 88 ACCESS CATHETER OVER A GUIDE WIRE. A ZOOM 71 AND A THIRD PARTY MICROCATHETER WERE ADVANCED OVER A GUIDEWIRE THROUGH THE ZOOM 88. AFTER POSITIONING THE ZOOM 71, MICROCATHETER, AND GUIDEWIRE IN THE LEFT PCA, THE ZOOM 88 WAS ADVANCED TO THE LEFT PCA. THE GUIDEWIRE, THIRD PARTY MICROCATHETER, AND ZOOM 71 WERE THEN REMOVED FROM THE PATIENT AND ASPIRATION WAS APPLIED TO THE ZOOM 88 FOR APPROXIMATELY TWO MINUTES. THE CLOT IN THE BASILAR ARTERY WAS REMOVED; HOWEVER, THE PCA REMAINED OCCLUDED. A SECOND PASS WAS COMPLETED WITH A ZOOM 45 CATHETER, A THIRD PARTY MICROCATHETER, AND A GUIDEWIRE ADVANCED THROUGH THE SAME ZOOM 88 AND POSITIONED IN THE LEFT PCA. THE ZOOM 88 WAS THEN ADVANCED TO THE LEFT PCA. THE THIRD PARTY MICROCATHETER AND GUIDEWIRE WERE THEN REMOVED. ASPIRATION WAS APPLIED FOR APPROXIMATELY TWO MINUTES TO THE ZOOM 45 AND ZOOM 88 CATHETERS, BUT NO CLOT WAS REMOVED. THE LEFT PCA REMAINED OCCLUDED. A THIRD PASS WITH THE SAME ZOOM 88, ZOOM 45, THIRD PARTY MICROCATHETER, AND GUIDEWIRE WAS COMPLETED. WHILE ADVANCING THE G

  Patient problems: Gastritis; Hernia; Perforation of Vessels

  MAUDE report 17014432 ↗
• InjuryFeb 21, 2023Break; Material Separation; Break; Material Separation

  A 66-YEAR-OLD FEMALE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE LEFT M2. A COMPETITOR'S BALLOON GUIDE CATHETER WAS ADVANCED AND PARKED AT THE PROXIMAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ADVANCED THE ZOOM 45 ASPIRATION CATHETER TO THE FACE OF THE CLOT. DURING CLOT RETRIEVAL ON THE FIRST PASS, THE PHYSICIAN FELT RESISTANCE ON THE ZOOM 45 WHILE PULLING IT BACK INSIDE THE GUIDE CATHETER. THE PHYSICIAN NOTICED A KINK IN THE COMPETITOR'S GUIDE CATHETER- APPROXIMATELY 15CM FROM THE DISTAL TIP. AFTER APPLYING MORE RETRIEVAL FORCE, THE PHYSICIAN FELT THE RESISTANCE GIVE WAY AND WAS ABLE TO REMOVE THE ZOOM 45 CATHETER FROM THE PATIENT. IN A FOLLOW-UP ANGIOGRAPHY THE PHYSICIAN NOTICED THAT A PORTION OF THE ZOOM 45 CATHETER WAS STILL IN THE PATIENT. THE LOCATION OF THE BREAK ON THE ZOOM 45 WAS NOT SPECIFIED. A SNARE WAS USED TO SUCCESSFULLY CAPTURE THE ZOOM 45 PIECE AND REMOVE IT FROM THE PATIENT'S BODY. FOLLOWING THE REMOVAL OF THE COMPETITOR BALLOON GUIDE CATHETER, THE PHYSICIAN PROCEEDED THE CASE WITH DIFFERENT COMPETITOR GUIDE CATHETER. HOWEVER, THE REPLACEMENT GUIDE CATHETER ALSO KINKED APPROXIMATELY 15CM FROM THE DISTAL TIP. THE PATIENT'S ANATO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414812 ↗
• InjuryMay 12, 2022Adverse 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 M2. FIRST, FOUR PASSES WERE CONDUCTED WITH TWO SIZES OF STENT RETRIEVERS AND COMPETITOR'S 5F AND 6F ASPIRATION CATHETERS. AFTER THE FOUR UNSUCCESSFUL ATTEMPTS TO OPEN THE OCCLUSION, A ZOOM 45 ASPIRATION CATHETER WAS SUCCESSFULLY USED TO REMOVE THE CLOT AND FLOW WAS RESTORED. THE PHYSICIAN OBSERVED A VESSEL DISSECTION DURING THE ROUTINE CONTRAST RUN PERFORMED POST CLOT REMOVAL. A STENT WAS THEN PLACED THROUGH THE VESSEL AND FLOW WAS CONFIRMED. THERE WERE NO DEVICE DEFICIENCIES REPORTED. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED TO REHAB, AND THE STENT WAS REPORTEDLY OPEN.

  Patient problems: Vascular Dissection

  MAUDE report 14382925 ↗

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