Zebra AC6074-095-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857545008158), received between Feb 10, 2026 and May 15, 2026 — classified as 2 malfunctions.

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.

• MalfunctionMay 15, 2026Break

  DURING A NEUROVASCULAR PROCEDURE, A ZEBRA 6 FR CATHETER (FG 01194-01, LOT FG250917C-02) WITH A SIM2 DISTAL CONFIGURATION WAS REPORTEDLY USED FOR VASCULAR ACCESS. DURING THE PROCEDURE, THE DISTAL SIM2 TIP SEGMENT REPORTEDLY SEPARATED FROM THE CATHETER. LIMITED PROCEDURAL DETAILS WERE AVAILABLE AT THE TIME OF MDR SUBMISSION DESPITE FOLLOW-UP ATTEMPTS WITH THE SALES REPRESENTATIVE AND PHYSICIAN. NO ADDITIONAL INFORMATION REGARDING THE EXACT PROCEDURAL SEQUENCE, RESISTANCE ENCOUNTERED, PATIENT OUTCOME, OR RETRIEVAL DETAILS WAS AVAILABLE. ONLY THE SEPARATED SIM2 DISTAL TIP SEGMENT WAS RETURNED FOR EVALUATION. RETURNED PRODUCT ANALYSIS IDENTIFIED COMPLETE SEPARATION OF THE DISTAL TIP SEGMENT WITH MEASURED ELONGATION OF APPROXIMATELY 4.5 CM RELATIVE TO NOMINAL MANUFACTURED LENGTH, CONSISTENT WITH SIGNIFICANT TENSILE LOADING PRIOR TO SEPARATION. NO EVIDENCE OF MANUFACTURING OR MATERIAL NONCONFORMANCE WAS IDENTIFIED IN THE RETURNED SEGMENT EVALUATION. THE OBSERVED DAMAGE MORPHOLOGY WAS CONSISTENT WITH MECHANICAL OVERSTRESS ENCOUNTERED DURING CLINICAL USE. AT THE TIME OF THIS REPORT, NO ADDITIONAL PATIENT INJURY INFORMATION HAD BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25191804 ↗
• MalfunctionFeb 10, 2026Insufficient Device Problem Information

  ON JANUARY 13, 2026, Q'APEL MEDICAL RECEIVED FDA MEDWATCH REPORT (B)(4). THE REPORT WAS SUBMITTED IN NOVEMBER 2025 REGARDING A NEUROLOGICAL PROCEDURE REPORTEDLY PERFORMED IN (B)(6) 2025 AT (B)(6). THE MEDWATCH NARRATIVE STATED: "A VASCULAR CATHETER WAS THREADED THROUGH AN AORTIC STENT, AND THE CATHETER TIP WAS SHEARED OFF AND RETAINED WITHIN STENT AFTER TREATMENT." Q'APEL MEDICAL INITIATED FOLLOW-UP EFFORTS UPON RECEIPT OF THE MEDWATCH REPORT. MULTIPLE GOOD-FAITH ATTEMPTS WERE MADE TO CONTACT THE REPORT AUTHOR TO OBTAIN ADDITIONAL CLINICAL DETAILS, INCLUDING CONFIRMATION OF THE REPORTED EVENT, PATIENT OUTCOME, DEVICE IDENTIFICATION (PRODUCT NAME, LOT NUMBER), AND AVAILABILITY OF THE DEVICE FOR RETURN EVALUATION. AS OF FEBRUARY 10, 2026, Q'APEL MEDICAL HAS NOT RECEIVED A RESPONSE TO THESE FOLLOW-UP REQUESTS. THE DEVICE REFERENCED IN THE MEDWATCH REPORT WAS NOT RETURNED TO Q'APEL MEDICAL. THEREFORE, NO PHYSICAL DEVICE EVALUATION, DIMENSIONAL INSPECTION, OR FAILURE ANALYSIS COULD BE PERFORMED. DUE TO LIMITED INFORMATION PROVIDED IN THE MEDWATCH REPORT AND THE LACK OF RESPONSE TO FOLLOW-UP ATTEMPTS, Q'APEL MEDICAL WAS UNABLE TO CONFIRM: THE SPECIFIC Q'APEL PRODUCT INVOLVED (IF ANY), TH

  Patient problems: Insufficient Information

  MAUDE report 24310486 ↗