ZOOM™ Reperfusion Catheter ICRC071137 (UDI 00812212030061)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812212030061), received between Jan 9, 2020 and Dec 16, 2020 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2020Break; Break

  A THROMBECTOMY WAS PERFORMED TO TREAT OCCLUSION IN THE RIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE ACCESS CATHETER WAS DELIVERED OVER AN INTERMEDIATE CATHETER AND 035 GUIDEWIRE TO ACCESS THE RIGHT COMMON CAROTID. IMAGING DEMONSTRATED AN EXTREMELY TORTUOUS TAKEOFF FROM THE AORTIC ARCH. AFTER TWO INITIAL PASSES WITH A ZOOM 71 REPERFUSION CATHETER, THE PHYSICIAN NOTED KINK AT TWO LOCATIONS WITHIN THE ACCESS CATHETER - ONE IN THE DISTAL SEGMENT AND ANOTHER IN THE MID SHAFT. ZOOM 71 REPERFUSION CATHETER ENCOUNTERED RESISTANCE WHICH PROMPTED THE REMOVAL OF THE ZOOM 71 FOR A NEW ZOOM 71. AFTER THE FIRST PASS WITH THE NEW ZOOM 71, HE ENCOUNTERED SIGNIFICANT RESISTANCE WHEN PULLING BACK. THE OUTER SHAFT ENDED UP BREAKING WITHIN THE PATIENT WITHOUT SEPARATING. THE PHYSICIAN PROCEEDED TO REMOVE THE ACCESS CATHETER AND ZOOM 71 REPERFUSION CATHETER AS ONE UNIT, AND WAS ABLE TO REMOVE THE ZOOM 71 REPERFUSION CATHETER FROM THE ACCESS CATHETER AFTER STRAIGHTENING THE KINK. THERE WAS NO ADVERSE EVENT OR NEGATIVE PATIENT OUTCOME. THE PATIENT IS DOING FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023335 ↗
• 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 10833262 ↗
• 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 10477796 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE IMPERATIVE CARE ZOOM 071 REPERFUSION CATHETER WAS DELIVERED OVER A STRYKER SYNCHRO2 014 GUIDEWIRE AND PENUMBRA 3MAX REPERFUSION CATHETER TO THE SITE OF THE OCCLUSION. THE SYNCHRO2 AND 3MAX WERE REMOVED, THEN ASPIRATION WAS STARTED THOUGH THE ZOOM 071. SUCCESSFUL REVASCULARIZATION OF THE VESSEL WAS CONFIRMED ON THE POST ASPIRATION CONTRAST RUN, BUT ACTIVE EXTRAVASATION WAS NOTED IN THE M1 MCA REGION NEAR THE SITE OF THE CLOT. AS THE ZOOM 071, 3MAX, AND SYNCHRO2 014 GUIDEWIRE WERE ALL ADVANCED TO THE CLOT SITE, IT IS POSSIBLE ONE OF THE DEVICES CAUSED THE EXTRAVASATION. TO ADDRESS THE EXTRAVASATION, THE PHYSICIAN USED A SCEPTER XC BALLOON CATHETER TO OCCLUDE THE M1 MCA AND ADMINISTERED MEDICATION. PATIENT WAS DOING WELL POST TREATMENT AND DISCHARGED FROM THE HOSPITAL TWO DAYS POST PROCEDURE.

  Patient problems: Extravasation

  MAUDE report 9572417 ↗