Zebra AC6074-105Recalls & reported problems
Q'Apel Medical LLC · The Neurovascular Access System Family consists of sterile, single-use catheters and accessories that are used together to facilitate the insertion and guidance of an appropriately sized interventional device into a selected vessel in the peripheral and neurovasculature. The Neurovascular Access System is comprised of the Neurovascular Access Catheter, Peel Away Introducer and Dilator. The Neurovascular Access System Family is offered in various lengths to accommodate physician preferences and anatomical variations. The distal end of the catheter is coated with hydrophilic coating to reduce friction during use and a radiopaque marker on the distal tip that is visible under fluoroscopy. · Class 2
All models of Zebra (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857545008400), received between Aug 8, 2026 and Aug 8, 2026 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Failure to Advance1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2026Break; Failure to Advance; Material Deformation
On July 13, 2026, Q'Apel Medical became aware of a reported device malfunction involving a Q'Apel Medical Zebra Neurovascular Access Catheter, 6F x 105 cm (REF AC6074-105, Lot FG260401B-01), that occurred on (b)(6) 2026 during a left middle meningeal artery (MMA) embolization procedure at (b)(6) Hospital. Per the site report, the procedure was converted from a right radial to a femoral approach due to tortuous anatomy. While advancing a microcatheter through the subject catheter, resistance was encountered. The physician removed the subject catheter and the catheter was noted to have separated into two pieces during this removal. No additional retrieval device or intervention was required; both separated components were removed from the patient without difficulty. A replacement catheter was used and the procedure was completed without further complication. The site reported no patient injury or adverse clinical outcome; the only reported impact was a prolonged procedure.Returned product analysis identified two separated catheter shaft segments: a proximal segment measuring approximately 31 cm and a distal segment measuring approximately 80.5 cm (combined approximately 111.5 cm, app
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187258 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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