Zebra AC7087-095-20-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00857545008233), received between Jun 23, 2025 and Mar 2, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  DURING A NEUROVASCULAR PROCEDURE PERFORMED BY DR. (B)(6), A ZEBRA WAS USED VIA A 7F SLENDER INTRODUCER SHEATH. AFTER SELECTION OF THE RIGHT INTERNAL CAROTID ARTERY AND REMOVAL OF A 5F SIM2 COOK CATHETER, THE ADJUNCTIVE DEVICES (VECTA 46, V17, AND SYNCHRO) WERE ADVANCED THROUGH THE ZEBRA CATHETER, A FRACTURE WAS OBSERVED AT THE DISTAL SEGMENT. A 0.035" GLIDEWIRE WOULD NOT PASS THROUGH THE FRACTURED REGION. THE ZEBRA CATHETER WAS GENTLY WITHDRAWN FROM THE PATIENT; THE SHAFT REMAINED ATTACHED DURING REMOVAL, BUT COMPLETELY SEPARATED AFTER EXITING THE SHEATH. AT THE TIME OF THIS REPORT, Q'APEL MEDICAL HAS NOT RECEIVED THE DEVICE FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 24480527 ↗
• MalfunctionMar 2, 2026Fracture

  ON (B)(6) 2026, DURING A LEFT CAROTID ARTERY STENTING (CAS) PROCEDURE PERFORMED VIA RIGHT RADIAL ACCESS, A ZEBRA CATHETER WAS POSITIONED IN THE PROXIMAL COMMON CAROTID ARTERY. DUE TO NEAR-COMPLETE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY, MULTIPLE ATTEMPTS WERE MADE TO ADVANCE ANCILLARY DEVICES. DURING ONE ATTEMPT, CONTRAST LEAKAGE WAS VISUALIZED FLUOROSCOPICALLY FROM THE CATHETER AT THE CURVE OF THE BRACHIOCEPHALIC ARTERY. THE CATHETER REMAINED IN POSITION TO PROVIDE SUPPORT AND WAS WITHDRAWN FOLLOWING COMPLETION OF THE PROCEDURE. NO FRAGMENTS WERE RETAINED, AND NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A CATHETER SHAFT BREACH APPROXIMATELY 19 CM FROM THE DISTAL TIP (77 CM FROM THE HUB), AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. THE DEVICE WAS RETURNED IN ONE PIECE. MICROSCOPIC AND VISUAL INSPECTION OF THE FRACTURE REGION DEMONSTRATED UNIFORM REINFORCEMENT CUT SPACING WITH NO ABNORMAL PITCH VARIATION OR REINFORCEMENT STRUT FRACTURE. THE DAMAGE PATTERN WAS CHARACTERIZED BY LOCALIZED MECHANICAL STRAIN BETWEEN REINFORCEMENT CUTS, RESULTING IN SHEARING OF THE OUTER POLYMER JACKET AND A SLIGHT OPENING OF THE INTERN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480485 ↗
• MalfunctionFeb 25, 2026Fracture

  ON JANUARY 27, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA 7F 95 CM BERNSTEIN CATHETER DURING AN ANEURYSM EMBOLIZATION PROCEDURE PERFORMED VIA RADIAL ACCESS. AFTER SELECTING THE RIGHT INTERNAL CAROTID ARTERY AND REMOVING A 5F SIM2 COOK CATHETER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A VECTA 46, V17, AND SYNCHRO THROUGH THE ZEBRA CATHETER. A 0.035" GLIDEWIRE WOULD NOT PASS. A FRACTURE WAS OBSERVED IN VIVO AT APPROXIMATELY THE DISTAL ONE-THIRD OF THE CATHETER. THE DEVICE WAS GENTLY WITHDRAWN AND REMAINED INTACT DURING REMOVAL; HOWEVER, COMPLETE SEPARATION OCCURRED AFTER EXITING THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CATHETER. NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT. NO VESSEL INJURY, DISSECTION, PERFORATION, EMBOLIZATION, VASOSPASM, ADDITIONAL INTERVENTION, OR ADVERSE CLINICAL OUTCOME WAS REPORTED. THE PATIENT OUTCOME WAS STABLE. RETURNED PRODUCT EVALUATION CONFIRMED A CATHETER SHAFT SEPARATION LOCATED APPROXIMATELY 19-20 CM FROM THE DISTAL TIP AT THE JACKET TRANSITION REGION. MICROSCOPIC EXAMINATION DEMONSTRATED SEPARATION OF THE LASER CUT TUBE (LCT) WITH INWARD COLLAPSE TOWARD THE LUMEN AND ASSOCIATED POLYMER DISRUPTION. THE FRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449289 ↗
• MalfunctionFeb 16, 2026Fracture

  ON JANUARY 16, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA CATHETER. DURING A RADIAL MMA EMBOLIZATION PROCEDURE, THE USER OBSERVED A KINK IN THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CATHETER WITH NO REPORTED PATIENT INJURY. EVALUATION OF THE RETURNED DEVICE CONFIRMED A LOCALIZED CATHETER WALL BREACH/FRACTURE LOCATED APPROXIMATELY 9 CM DISTAL TO THE STRAIN RELIEF, AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. VISUAL INSPECTION CONFIRMED A LOCALIZED KINK IN THE SHAFT AT THIS SAME LOCATION, CONSISTENT WITH THE REPORTED COMPLAINT. ADDITIONAL KINKS WERE ALSO OBSERVED APPROXIMATELY 5 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL COIL SPACING OR PITCH VARIATION, AND THE DISTAL TIP SHOWED NO ABNORMALITIES. THE OBSERVED DAMAGE PATTERN WAS CONSISTENT WITH LOCALIZED MECHANICAL DEFORMATION/STRETCHING. NO EVIDENCE OF A DESIGN ANOMALY OR MANUFACTURING DEFECT WAS OBSERVED WITHIN THE SCOPE OF THE RETURNED PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24357076 ↗
• MalfunctionFeb 10, 2026Fracture

  ON (B)(6) 2025, DURING A RADIAL ACCESS CAROTID STENT PROCEDURE, THE USER OBSERVED A KINK AND A SMALL HOLE ON A ZEBRA CATHETER AFTER COMPLETION OF THE PROCEDURE AND FOLLOWING REMOVAL OF THE DEVICE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT REPORTED PATIENT INJURY, AND THE DEVICE WAS SET ASIDE FOR RETURN EVALUATION. THE USER REPORTED THAT NO RESISTANCE OR TORQUING WAS ENCOUNTERED DURING USE. EVALUATION OF THE RETURNED DEVICE CONFIRMED A CATHETER BREACH/FRACTURE APPROXIMATELY 12 CM FROM THE HUB, AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. THREE KINK LOCATIONS WERE IDENTIFIED ALONG THE CATHETER SHAFT; HOWEVER, ONLY ONE LOCATION EXHIBITED A CONFIRMED BREACH/FRACTURE, WITH THE REMAINING KINK REGIONS SHOWING NO VISIBLE BREACH CHARACTERISTICS. MICROSCOPIC AND VISUAL INSPECTION OF THE FRACTURE REGION SHOWED UNIFORM REINFORCEMENT CUT SPACING WITH NO INDICATION OF REINFORCEMENT FRACTURE. THE OBSERVED DAMAGE PATTERN WAS CONSISTENT WITH LOCALIZED OVERSTRETCHING BETWEEN REINFORCEMENT CUTS RESULTING IN SHEARING OF THE OUTER JACKET AND A SLIGHT OPENING OF THE INTERNAL PTFE LINER. NO EVIDENCE OF DESIGN OR MANUFACTURING NONCONFORMANCE (E.G., IMPROPER LAMINATION, ABNORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310855 ↗
• MalfunctionJun 23, 2025Fracture; Fracture

  ON (B)(6) 2025, DURING AN ISCHEMIC STROKE THROMBECTOMY PROCEDURE, A 7F ZEBRA CATHETER WAS USED TO TRACK OVER A 6F PENUMBRA SIM2 SELECT CATHETER INTO THE INTERNAL CAROTID ARTERY. FOLLOWING THE WITHDRAWAL OF THE SIM2, A PENUMBRA RED 72 ASPIRATION CATHETER WAS INTRODUCED FOR ADVANCEMENT THROUGH THE ZEBRA. UPON ADVANCEMENT INTO THE BRACHIOCEPHALIC ARTERY, RESISTANCE WAS ENCOUNTERED, AND THE ZEBRA CATHETER WAS SUSPECTED TO HAVE KINKED, PREVENTING FURTHER ADVANCEMENT OF THE RED 72. A SUBSEQUENT ATTEMPT USING A RED 62 CATHETER WAS ALSO UNSUCCESSFUL. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A BMX 81 AND RED 62 CATHETER. NO PATIENT HARM OR ADVERSE EVENTS WERE REPORTED. THE DEVICE WAS RETURNED AND RECEIVED BY THE MANUFACTURER WITH NO PARTS VISUALLY MISSING. FAILURE ANALYSIS OF THE REPORTED WAS PERFORMED. VISUAL INSPECTION OF THE RETURNED ZEBRA CATHETER REVEALED A FRACTURE-RATHER THAN A KINK-WITH THE DEVICE SEPARATING INTO TWO SEGMENTS DURING REMOVAL OF THE RED 62 CATHETER. THE PROXIMAL AND DISTAL SEGMENTS OF THE RETURNED LCT CATHETER WAS KINK TESTED AND MET THE DEFINED PERFORMANCE SPECIFICATIONS. BASED ON THE COMPLAINT DETAILS, PROCEDURAL CONTEXT, AND VISUAL FINDINGS, THE MOST PROBABLE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307452 ↗