Zebra AC6074-095-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857545008189), received between Mar 24, 2026 and May 21, 2026 — classified as 1 injury, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Break

  DURING AN MMA EMBOLIZATION PROCEDURE PERFORMED VIA FEMORAL ACCESS ON (B)(6) 2026, RESISTANCE WAS REPORTEDLY ENCOUNTERED BY THE PHYSICIAN DURING WITHDRAWAL OF A ZEBRA 6F 95 CM CATHETER WITHIN TORTUOUS ILIAC ANATOMY. THE PHYSICIAN REPORTED ASSOCIATED VESSEL SPASM, AFTER WHICH THE CATHETER REPORTEDLY KINKED, TWISTED, AND SEPARATED DURING REMOVAL ATTEMPTS. THE SEPARATED CATHETER SEGMENTS WERE REPORTEDLY RETRIEVED USING A SNARE, AND NO FRAGMENTS WERE REPORTED TO REMAIN IN THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING RETRIEVAL OF THE CATHETER SEGMENTS. THE PRODUCT WAS RETURNED IN FOUR SHAFT SEGMENTS. EVALUATION IDENTIFIED MULTIPLE FRACTURE/SEPARATION LOCATIONS. THE COMBINED SEGMENT LENGTHS WERE CONSISTENT WITH THE MANUFACTURED DEVICE LENGTH SPECIFICATION, AND NO SIGNIFICANT ELONGATION WAS IDENTIFIED. VISUAL AND MICROSCOPIC EVALUATION IDENTIFIED TWISTING, FLATTENING, PINCHING, AND LOCALIZED COMPRESSION DAMAGE ACROSS MULTIPLE REGIONS OF THE CATHETER. THE FRACTURE MORPHOLOGY APPEARED TORN AND IRREGULAR, CONSISTENT WITH MECHANICAL STRESS DURING DEVICE REMOVAL AND RETRIEVAL. FEED GAP SPACING AND REINFORCEMENT PATTERN WERE OBSERVED TO BE UNIFORM THROUGHOUT THE EVALUATED REGIONS

  Patient problems: Insufficient Information

  MAUDE report 25239303 ↗
• MalfunctionMar 24, 2026Fracture

  ON (B)(6), 2026, Q'APEL MEDICAL BECAME AWARE OF A REPORTED ZEBRA 6F 95 CM BERNSTEIN CATHETER FRACTURE THAT OCCURRED DURING A PIPELINE EMBOLIZATION PROCEDURE. THE DEVICE WAS INTRODUCED VIA A MERIT 22 CM 7F SHEATH AND ADVANCED TO THE HIGH PETROUS CAROTID THROUGH TORTUOUS ANATOMY, INCLUDING A 360-DEGREE CERVICAL CAROTID LOOP. THE CATHETER WAS INSPECTED PRIOR TO USE AND NO DEFECTS WERE OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY. DURING WITHDRAWAL OF THE ZEBRA CATHETER THROUGH THE STATIONARY SHEATH, WHICH WAS NOT RETRACTED, RESISTANCE WAS ENCOUNTERED IN THE CERVICAL CAROTID REGION. THE PHYSICIAN REPORTED THAT THE CATHETER WAS NOT ROTATED, NO VASOSPASM OCCURRED, AND NO EXCESSIVE FORWARD PRESSURE WAS APPLIED. THE PHYSICIAN INDICATED THE MALFUNCTION LIKELY OCCURRED DURING WITHDRAWAL. FOLLOWING REMOVAL, A KINK WAS OBSERVED AND FLUID LEAKAGE WAS NOTED AT THE KINK SITE. NO MULTIPLE REPOSITIONING ATTEMPTS WERE REQUIRED, AND NO TIP MODIFICATION WAS PERFORMED. THE DEVICE WAS REMOVED FROM THE PATIENT AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6), 2026. RETURNED PRODUCT ANALYSIS CONFIRMED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676979 ↗