ZOOM™ Reperfusion Catheter ICRC071137 (UDI 00812212030191)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00812212030191), received between Nov 26, 2020 and May 12, 2022 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K183043); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING TREATED FOR AN OCCLUSION AT THE RIGHT INTERNAL CAROTID ARTERY (ICA) M2 SEGMENT. THE PATIENT HAD A HISTORY OF SEPTIC EMBOLI, "BAD" ENDOCARDITIS, AND WAS AN IV DRUG USER. ACCESS WAS OBTAINED USING A GUIDEWIRE, COMPETITOR GUIDE CATHETER AND COMPETITOR LARGE BORE CATHETER. THE PHYSICIAN STATED THAT HE HAD DIFFICULTY ADVANCING THE GUIDEWIRE BUT WAS SUBSEQUENTLY ABLE TO MAKE FIVE UNSUCCESSFUL PASSES WITH A COMBINATION OF COMPETITOR GUIDE CATHETER, STENT RETRIEVER AND ASPIRATION CATHETERS. A ZOOM 71 ASPIRATION CATHETER WAS NEXT ADVANCED TO THE VESSEL AND FLOW WAS RESTORED. SUBSEQUENTLY THE VESSEL SHUT DOWN WHICH WAS ATTRIBUTED TO A VESSEL DISSECTION. A STENT WAS THEN PLACED IN THE VESSEL AND FLOW WAS RESTORED. THE PATIENT WAS TRANSFERRED TO THE ICU WARD BECAUSE OF COMPLICATED ENDOCARDITIS.

  Patient problems: Vascular Dissection

  MAUDE report 14383101 ↗
• MalfunctionJan 7, 2022Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE ISCHEMIC STROKE SECONDARY TO AN AUTOMOBILE ACCIDENT. THE PATIENT WAS ALSO BEING TREATED FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) IN THE TARGET VESSEL FOR THROMBECTOMY (M1). A TOTAL OF THREE PASSES WERE MADE. AFTER THE FIRST PASS, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING ZOOM 71 THROUGH THE ICI ROTATING HEMOSTASIS VALVE (RHV). THE ENTIRE ZOOM 71 WAS REMOVED AND UPON OBSERVATION ON THE OPERATING TABLE, IT WAS NOTICED THE CATHETER SHAFT HAD FRACTURED. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF THIS CATHETER. THE PHYSICIAN COMMENTED THE CATHETER WAS CAUGHT ON THE RHV WHICH WAS POSSIBLY NOT FULLY OPENED WHEN RETRACTING. THE DEVICE WAS REPLACED WITH ANOTHER ZOOM 71 AND SECOND PASS WAS PERFORMED WITHOUT ANY ISSUES. SECOND ZOOM 71 WAS REMOVED, AND THE PHYSICIAN MADE THE THIRD PASS USING ZOOM 55. THE CASE WAS COMPLETED WITH SUCCESSFUL REPERFUSION OF M1 SEGMENT. IN ADDITION, THE PATIENT WAS TREATED FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) WITH ANGIOPLASTY AND STENT. THE PATIENT WAS REPORTED AS STABLE. THERE WERE NO PATIENT SEQUALAE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13198027 ↗
• MalfunctionDec 22, 2021Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A BASILAR OCCLUSION. SINCE BOTH ILIAC ARTERIES WERE OCCLUDED, ACCESS WAS OBTAINED THROUGH THE LEFT RADIAL ARTERY. A SHARP BEND WAS NOTED OFF THE SUBCLAVIAN ARTERY. ZOOM 88 WAS ADVANCED TO THE DISTAL CERVICAL VERTEBRAL ARTERY WITHOUT ANY ISSUES. FIRST PASS WAS MADE SUCCESSFULLY USING ZOOM 71 OPENING THE BASILAR AND ONE POSTERIOR CEREBRAL ARTERY (PCA). DURING SECOND PASS ATTEMPT, RESISTANCE WAS NOTED WHEN ADVANCING THE SAME ZOOM 71 THROUGH THE ZOOM 88. ZOOM 71 WAS REMOVED AND THE PHYSICIAN DECIDED TO REPLACE IT WITH A COMPETITOR CATHETER. SINCE RESISTANCE WAS FELT WHEN ADVANCING THE COMPETITOR CATHETER, THE PHYSICIAN DECIDED TO END THE CASE WITHOUT COMPLETING THE PASS AS TICI 2B WAS ACHIEVED. SEVERAL DAYS LATER, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED A FOREIGN BODY IN THE LEFT PCA. CLINICAL DECISION WAS MADE TO NOT REMOVE THE FRAGMENT. THE PHYSICIAN REVIEWED THE IMAGING FROM THE CASE AND NOTICED A TIP. PER THE PHYSICIAN, IT IS UNKNOWN IF THE TIP WAS DETACHED FROM THE ZOOM OR THE COMPETITOR'S DEVICE. THERE WAS NO INTERVENTION PERFORMED AND NO PATIENT SEQUALAE REPORTED. NOTE THAT THERE WERE TWO VOLUNTARY MEDWATCH REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062084 ↗
• InjuryNov 24, 2021Entrapment of Device

  THE PATIENT REQUIRED AN ACUTE STROKE INTERVENTION SECONDARY TO AN OCCLUSION IN THE LEFT PROXIMAL BASILAR ARTERY. DURING THE PROCEDURE, A MINUTE CATHETER TIP FRAGMENT WAS EMBEDDED IN THE LEFT PCA. CLINICAL DECISION WAS MADE TO NOT REMOVE THE FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12871283 ↗
• InjuryNov 23, 2021Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUSION WITHIN THE RIGHT INTERNAL CAROTID ARTERY (ICA) TERMINUS AND MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT. INTERVENTIONAL NEUROLOGIST ATTEMPTED SIX PASSES WITH A BALLOON GUIDE CATHETER, LARGE BORE ASPIRATION CATHETER (LBC), MICROCATHETER, REVASCULARIZATION CATHETER AND STENT RETRIEVER. SINCE THE OCCLUSION WAS NOT RESOLVED, THE PHYSICIAN DECIDED TO USE THE ZOOM SYSTEM. ACCESS WAS OBTAINED THROUGH THE LEFT GROIN WITH AN 8F SHUTTLE, A VTK SELECT CATHETER AND A 038 GUIDEWIRE. ZOOM 71 WAS ADVANCED TO THE CLOT OVER THE MICROCATHETER AND GUIDEWIRE. USING A 60CC SYRINGE, THE PHYSICIAN APPLIED ASPIRATION. THE PHYSICIAN THEN TRIED TO ADVANCE ZOOM 88 TO THE CLOT, BUT IT COULD NOT PASS THE PATIENT'S OPHTHALMIC ARTERY. HE TRIED ROTATING ZOOM 88 TO CHANGE THE ORIENTATION OF THE TIP BUT WAS UNSUCCESSFUL. THE ZOOM71 WAS THEN USED TO PERFORM THE THROMBECTOMY. WHEN HE TRIED TO RETRACT THE ZOOM71, HE NOTICED THAT THERE WAS NO ONE-TO-ONE MOVEMENT (AS THE PHYSICIAN WAS PULLING BACK THE PROXIMAL END THE CATHETER WAS MOVING OUTSIDE THE PATIENT, BUT HE DIDN'T NOT SEE DISTAL CATHETER MOVEMENT ON ANGIOGRAPHY). HE OBSERVED THAT THE ZOOM71 CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865768 ↗
• MalfunctionNov 19, 2021Material Fragmentation

  THE PATIENT REQUIRED AN ACUTE STROKE INTERVENTION SECONDARY TO AN OCCLUSION IN THE LEFT PROXIMAL BASILAR ARTERY. DURING THE PROCEDURE, A MINUTE CATHETER TIP FRAGMENT WAS EMBEDDED IN THE LEFT PCA. CLINICAL DECISION WAS MADE TO NOT REMOVE THE FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12845547 ↗
• InjuryJul 14, 2021Break; Break

  PATIENT PRESENTED WITH RIGHT M1 OCCLUSION. PHYSICIAN ACCESSED THE RIGHT FEMORAL WITH ACCESS CATHETER. THE ACCESS CATHETER WAS NAVIGATED TO THE RIGHT INTERNAL ARTERY JUST DISTAL TO THE BIFURCATION OF THE EXTERNAL OVER A 5FR SELECT CATHETER AND A .035 GUIDEWIRE (GW). THE SELECT CATHETER AND 0.035" GW WERE REMOVED. 0.014" GW, ZOOM 71 AND A 0.017" MICROCATHETER (MC) WERE ADVANCED TO THE CAVERNOUS CAROTID SEGMENT OF THE RIGHT ICA. THE MC AND GW WERE ADVANCED TO THE DISTAL MCA TERRITORY AND THE ZOOM 71 WAS ADVANCED TO THE M1 SEGMENT JUST PROXIMAL TO THE CLOT. A STENT RETRIEVER WAS ADVANCED THROUGH THE EMPTY MC TO THE LOCATION OF THE CLOT AND DEPLOYED. ASPIRATION WAS STARTED AND IT WAS NOTED THAT THE ZOOM 71 WAS NOT CORKED. AFTER A FEW MINUTES THE STENT RETRIEVER AND ZOOM 71 WERE REMOVED FROM THE PATIENT AND CLOT WAS NOTED ON THE STENT RETRIEVER. FOR THE SECOND PASS, THE 0.14 " GW, MC AND ZOOM 71 WERE RE-INTRODUCED INTO THE ACCESS CATHETER AND NAVIGATED TO THE CAVERNOUS CAROTID SEGMENT OF THE ICA. THE GW AND MC WERE THEN NAVIGATED TO THE DISTAL MCA TERRITORY AND THE ZOOM 71 WAS ADVANCED TO THE M1 SEGMENT. DURING THIS ADVANCEMENT PHYSICIAN MENTIONED HAVING DIFFICULTY ADVANCING THE ZOOM 71

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170727 ↗
• InjuryMay 26, 2021Break; Break

  THE PATIENT WAS UNDERGOING A STROKE CASE WITH BASILAR OCCLUSION. ACCESS WAS OBTAINED WITH A COMPETITOR ACCESS CATHETER UTILIZING A RADIAL APPROACH. THE ZOOM 71 WAS ADVANCED TO THE TARGET CLOT LOCATION WITH A COMPETITOR MICROCATHETER AND 0.014" GUIDEWIRE, BUT WAS WEDGED INTO THE DISEASED PLAQUE IN THE VERTEBRAL ARTERY. WHILE ATTEMPTING TO PULL OUT THE ZOOM 71 THE OPERATOR ENCOUNTERED RESISTANCE, AND UPON FURTHER RETRACTION THE ZOOM 71 RELEASED. INSPECTION OF THE REMOVED ZOOM 71 RESULTED IN THE TIP BEING OBSERVED AS SEPARATED. THE OPERATOR ATTEMPTED TO RETRIEVE THE SEPARATED TIP WITH A COMPETITOR STENT RETRIEVER AND WAS UNSUCCESSFUL. THE OPERATOR THEN ATTEMPTED TO ADVANCE A COMPETITOR INTERMEDIATE CATHETER WITH A NEW ACCESS CATHETER AND MICROCATHETER, BUT WAS ALSO UNABLE TO NAVIGATE TO THE SITE OF THE OCCLUSION. THE CASE WAS CONCLUDED AFTER USE OF THE COMPETITOR INTERMEDIATE CATHETER. THE PATIENT STATUS IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886573 ↗
• MalfunctionMay 11, 2021Break; Break

  INITIAL EVENT DESCRIPTION: PATIENT HAD A LEFT MCA ARTERY OCCLUSION. ACCESS WAS OBTAINED WITH A TRACSTAR IN THE CAVERNOUS ICA IN A GOOD DISTAL POSITION. THE PHYSICIAN MADE 1 PASS WITH ZOOM 71 TO THE CLOT AND ASPIRATED, NO CLOT WAS RETRIEVED. NO RESISTANCE WAS FELT WHILE ADVANCING THE ZOOM 71 TO THE CLOT LOCATION. PHYSICIAN MAY HAVE TRIED TO PUSH THE TRACSTAR INTO THE MCA WITHOUT SUCCESS THAT MAY HAVE BEEN CAUSE OF THE KINK IN TRACSTAR. PULLED BACK Z71 AT THIS POINT AND FELT RESISTANCE WHILE WITHDRAWING. UPON REMOVAL, NOTICED A KINK IN TRACSTAR AND THE Z71 TIP WAS DEFORMED. PHYSICIAN REPORTED THAT THE TIP OF THE ZOOM 71 WAS DEFORMED AND REMOVED THE TRACSTAR. IT WAS NOTED THAT NO PART OF THE CATHETER WAS LEFT BEHIND IN THE PATIENT AND THERE WAS NO HARM CAUSED TO THE PATIENT FROM THIS. HE COMPLETED THE PROCEDURE WITH A NEURON MAX .088 SHEATH AND A SOFIA .070 CATHETER. ACHIEVED TICI 3 REPERFUSION AFTER 1 PASS WITH SOFIA CATHETER. THERE WERE NO CLINICAL EVENT REPORTED. BASED ON POST OP CT THE PHYSICIAN MENTIONED THAT THE PATIENT LIKELY STILL HAD SOME RESIDUAL STROKE OF THE LEFT TERRITORY. THE INITIAL REPORTABILITY FOR THIS COMPLAINT WAS DETERMINED TO BE NOT REPORTABLE BASED ON THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810042 ↗
• 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 11486189 ↗
• InjuryJan 21, 2021Break; Break

  A THROMBECTOMY WAS PERFORMED TO TREAT OCCLUSION IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE ACCESS CATHETER ZOOM 88-T WAS DELIVERED OVER AN INTERMEDIATE CATHETER AND 038 GUIDEWIRE TO THE INTERNAL CAROTID ARTERY (ICA) TERMINUS. ZOOM 71 REPERFUSION CATHETER WAS ADVANCED TO THE FACE OF THE CLOT, AND REPERFUSION WAS ACHIEVED AFTER THE THIRD PASS. AFTER THE THIRD PASS, THE PHYSICIAN INJECTED CONTRAST THROUGH THE ZOOM 88-T, AND UNDER FLUOROSCOPY THE PHYSICIAN SAW THE ZOOM 71 TIP ADVANCE FROM THE ZOOM 88-T TO THE MCA. THE PHYSICIAN PROCEEDED TO USE A STENT RETRIEVER TO REMOVE THE ZOOM 71 TIP. THERE WERE NO FURTHER ADVERSE EVENTS OR NEGATIVE PATIENT OUTCOME POST REMOVAL OF ZOOM 71 TIP. THE PATIENT IS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11211362 ↗
• MalfunctionDec 16, 2020Break; Material Separation; Break; Material Separation

  PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON (B)(3) TO TREAT OCCLUSION WITHIN THE RIGHT INTERNAL CAROTID ARTERY (ICA). ACCESS WAS OBTAINED WITH TRACSTAR LDP ACCESS CATHETER. ZOOM 71 REPERFUSION CATHETER WAS ADVANCED TO THE CLOT LOCATION OVER A ZOOM 35 REPERFUSION CATHETER. FIRST PASS WAS MADE WITH THE ZOOM 71 AND ZOOM 35 IN THE CAROTID TERMINUS WITHOUT INCIDENT. SECOND PASS WAS MADE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT USING THE ZOOM 71 AND ZOOM 35 WITHOUT INCIDENT AS WELL. PHYSICIAN NOTED DISTAL CLOT IN THE RIGHT M3 SEGMENT OF THE MCA, AND WITH THE ZOOM 71 PLACED AT THE DISTAL M1 PROCEEDED TO ADVANCE THE ZOOM 35 TO THE CLOT WITH ASPIRATION TURNED ON. THE ZOOM 35 AND THE ZOOM 71 WERE RETRACTED INTO TRACSTAR LDP TO BE WITHDRAWN FROM THE PATIENT. NO RESISTANCE WAS NOTED AT THE TIME OF WITHDRAWAL OF THE ZOOM 35 AND ZOOM 71 INTO THE TRACSTAR LDP. FOLLOW UP ANGIOGRAPHY DEMONSTRATED THAT THE MARKER BAND WAS DETACHED AND WITHIN THE DISTAL M1. AT THE TIME DISTAL FLOW WAS NOTED, AND NO FURTHER INTERVENTION WAS PERFORMED. THE CASE WAS COMPLETED WITH NO ADDITIONAL CLINICAL EVENT. PATIENT WAS NOTED TO BE STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11023364 ↗
• MalfunctionNov 26, 2020Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE ON (B)(3) TO TREAT OCCLUSION WITHIN THE MID BASILAR ARTERY. PATIENT DISPLAYED UNDERLYING ATHEROSCLEROSIS AT THE OCCLUSION SITE. ACCESS WAS OBTAINED AT THE DISTAL VERTEBRAL ARTERY USING THE ZOOM 88T 110CM WHICH WAS ADVANCED OVER A COMPETITOR ANGIOGRAPHIC CATHETER AND A 035 GUIDEWIRE. ZOOM 71 REPERFUSION CATHETER WAS SUBSEQUENTLY ADVANCED UNSUPPORTED TO THE SITE OF THE OCCLUSION AND SOME CLOT WAS REMOVED THROUGH THE ZOOM 71 CATHETER. A TOTAL OF TWO PASSES WERE PERFORMED. ZOOM 71 WAS PULLED INTO ZOOM 88 (TIP STILL INTACT) WITH RESISTANCE SEEN ON WITHDRAWAL. THE TIP SEPARATED INSIDE ZOOM 88 BUT WAS NOT NOTICED BY THE PHYSICIAN. COMPETITOR DEVICES WERE USED TO RETRIEVE MORE CLOT AND PHYSICIAN SAW THE TIP IN THE VERTEBRAL ARTERY. TIP WAS REMOVED USING STENT RETRIEVER AND COMPETITOR INTERMEDIATE CATHETER. THE PHYSICIAN PROCEEDED TO PERFORM ANGIOPLASTY TO ADDRESS THE MID BASILAR ATHEROSCLEROSIS WITH NO FURTHER ISSUES. THE CASE WAS COMPLETED WITH NO ADDITIONAL CLINICAL EVENT. PATIENT WAS NOTED TO BE STABLE POST OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10909469 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183043. 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