Zebra AC7087-105-20-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857545008226), received between Oct 23, 2025 and May 6, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Fracture

  DURING A NEUROVASCULAR PROCEDURE ON (B)(6) 2026, PERFORMED VIA FEMORAL ACCESS USING A 7FR SHEATH, A ZEBRA 7FR 105 CM SIM2 CATHETER WAS USED IN CONJUNCTION WITH A WINGSPAN SYSTEM. THE CATHETER WAS INSPECTED PRIOR TO USE, AND NO DEFECTS WERE OBSERVED. THE CATHETER WAS ADVANCED TO A HIGH CERVICAL POSITION; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING A MICROCATHETER AND MICROWIRE TO THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, A KINK WAS OBSERVED FLUOROSCOPICALLY IN THE AORTIC ARCH REGION. A SECOND KINK WAS SUBSEQUENTLY VISUALLY IDENTIFIED IN A SEGMENT OF THE CATHETER EXTERNAL TO THE PATIENT. SALINE LEAKAGE WAS OBSERVED AT THE LOCATION OF THE EXTERNAL KINK. THE CATHETER WAS FLUSHED FOLLOWING REMOVAL FROM THE PATIENT, CONFIRMING A LUMEN BREACH/FRACTURE CORRESPONDING TO THIS REGION. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ZEBRA CATHETER FROM THE SAME LOT, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. RETURNED PRODUCT EVALUATION CONFIRMED A LOCALIZED LUMEN BREACH/FRACTURE ASSOCIATED WITH THE EXTERNALLY KINKED REGION. MICROSCOPIC EVALUATION OF THE FRACTURE REGION DID NOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107623 ↗
• MalfunctionFeb 13, 2026Fracture

  ON JANUARY 15, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA CATHETER. DURING A RADIAL MMA EMBOLIZATION PROCEDURE, THE USER OBSERVED A KINK NEAR THE HUB TOWARD THE END OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY, AND THE DEVICE WAS REMOVED AND SET ASIDE FOR RETURN EVALUATION. THE USER REPORTED THAT NO ADDITIONAL CATHETERS WERE REQUIRED AND NO ADDITIONAL INTERVENTION WAS NECESSARY. FOLLOWING RETURNED PRODUCT EVALUATION, THE PHYSICIAN CONFIRMED THAT SALINE LEAKAGE WAS OBSERVED FROM THE KINK LOCATION DURING USE; HOWEVER, THE USER REPORTED THAT THE LEAKAGE DID NOT IMPACT THE PROCEDURE OUTCOME AND NO ADDITIONAL INTERVENTION WAS REQUIRED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A CATHETER WALL BREACH/FRACTURE LOCATED APPROXIMATELY 1 CM DISTAL TO THE STRAIN RELIEF, AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. VISUAL INSPECTION CONFIRMED A LOCALIZED KINK IN THE PROXIMAL SHAFT REGION NEAR THE HUB/STRAIN RELIEF, CONSISTENT WITH THE REPORTED COMPLAINT. ADDITIONAL KINKS WERE ALSO OBSERVED APPROXIMATELY 14-16 CM PROXIMAL TO THE DISTAL TIP. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL COIL SPACING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339712 ↗
• MalfunctionOct 23, 2025Break; Break

  ON (B)(6) 2025, DURING A RIGHT RADIAL ACCESS TO RIGHT CAROTID ARTERY STENTING PROCEDURE, SEQUENTIAL PRE-DILATION WAS PERFORMED USING A 5F SHORT SHEATH FOLLOWED BY A 6F SHORT SHEATH. A 7F ZEBRA SIM2 CATHETER WAS THEN INTRODUCED WITHOUT THE USE OF AN INTRODUCER SHEATH. A SPIDER FILTER WAS ADVANCED AND POSITIONED JUST BEYOND THE FIRST BEND IN THE PETROUS SEGMENT. A CONTEGO CAROTID STENT WAS SUCCESSFULLY DELIVERED AND DEPLOYED WITH SUPPORT FROM THE ZEBRA CATHETER. DURING RETRIEVAL OF THE STENT AND SPIDER FILTER SYSTEM, DIFFICULTY WAS ENCOUNTERED WHEN THE FILTER WIRE APPEARED TO KINK, PREVENTING PROPER CAPTURE WITHIN THE RETRIEVAL SHEATH. THE DAMAGED WIRE WAS SUBSEQUENTLY PULLED THROUGH THE DEPLOYED STENT, AND RESISTANCE WAS NOTED WHEN ALL COMPONENTS WERE WITHDRAWN THROUGH THE ZEBRA CATHETER. A CONTRAST RUN WAS THEN PERFORMED TO CONFIRM PROCEDURE COMPLETION. UPON SUBSEQUENT REMOVAL OF THE ZEBRA CATHETER, ADDITIONAL RESISTANCE WAS ENCOUNTERED, AND A SEPARATION OF THE CATHETER OCCURRED OUTSIDE OF THE PATIENT. THE CATHETER WAS SUCCESSFULLY REMOVED IN IT'S ENTIRETY. THERE WAS NO ADVERSE IMPACT TO THE DEPLOYED STENT, AND NO PATIENT HARM OR CLINICAL COMPLICATIONS WERE REPORTED. AT THE TIME OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373135 ↗