ZOOM™ Reperfusion Catheter ICRC035158 (UDI 00812212030092)Recalls & reported problems
Imperative Care, Inc. · ZOOM 035 158 cm RC · Class 2
All models of ZOOM Reperfusion Catheter (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812212030092), received between Sep 1, 2020 and Sep 1, 2020 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Extravasation1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 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)(3) TO TREAT AN OCCLUSION IN THE LEFT M1 AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE IMPERATIVE CARE ZOOM 071 REPERFUSION CATHETER WAS DELIVERED OVER A ZOOM 035 REPERFUSION CATHETER TO THE SITE OF OCCLUSION AT M1 MCA, AND ON FIRST PASS SOME CLOT WAS RETRIEVED WITH RESIDUAL CLOT REMAINING. USING THE SAME ZOOM 071 AND ZOOM 035 REPERFUSION CATHETER FOR THE SECOND PASS, THE PHYSICIAN WAS UNABLE TO RETRIEVE ADDITIONAL CLOT FROM THE M1 AND M2 MCA LOCATION. THE PHYSICIAN THEN OBSERVED HAZINESS WITH NO APPARENT PATIENT RESPONSE, AND THE M2 MCA ARTERY APPEARED TO BE SHUTTING DOWN. THE PHYSICIAN WAS CONCERNED THERE MAY HAVE BEEN A DISSECTION AND PROCEEDED TO REMOVE THE ZOOM 071 AND ZOOM 35 DEVICES FROM THE PATIENT. ON THE THIRD PASS THE PHYSICIAN SWITCHED TO TWO COMPETITOR CATHETERS, BUT AT THE CLOT SITE ENCOUNTERED EXTRAVASATION AS OBSERVED UNDER FLUOROSCOPY WITH APPARENT PATIENT RESPONSES. THE PHYSICIAN SUBSEQUENTLY REMOVED ALL DEVICES, AND USED A BALLOON CATHETER AND ONYX TO TREAT AND OCCLUDE THE EXTRAVASATION. THE EXTRAVASATION WAS THEN RESOLVED AND THE OPERATION WAS CONCLUDED. THE PATIENT IS CURRENTLY DOING WELL AND I
Patient problems: Extravasation; Vascular Dissection
MAUDE report 10477726 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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