AltaTrack AltaTrack Catheter BerensteinRecalls & reported problems
Philips Medical Systems Nederland B.V. · Angiographic catheter with FORS technology intended to deliver radiopaque media or lead a guidewire in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838070950), received between Jul 29, 2021 and Jul 29, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PERIPHERAL FEVAR PROCEDURE IN THE ABDOMINAL AORTA AND SIDE BRANCHES, THE ALTATRACK GUIDEWIRE (MDR #3003768277-2021-10502) AND ALTATRACK CATHETER (MDR #3003768277-2021-10501) WERE USED IN THE RIGHT RENAL ARTERY. AFTER NAVIGATION TO THE RIGHT RENAL ARTERY WITH A STEERABLE SHEATH, THE PHYSICIAN FELT RESISTANCE AND ANGIOGRAPHY SHOWED A DISSECTION OF THE RIGHT RENAL ARTERY. THE DISSECTION WAS TREATED BY PLACING A LONGER COVERED STENT THAN INITIALLY PLANNED INSIDE THE RIGHT RENAL ARTERY. THE PATIENT ENCOUNTERED NO HEMODYNAMIC INSTABILITY. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE. AFTER THE PROCEDURE, THE PHYSICIAN AND THE SURGEON INVOLVED REVIEWED THE ANGIOGRAM AND THOUGHT THE DISSECTION MIGHT HAVE BEEN CAUSED BY THE TIP OF THE GUIDEWIRE DURING CATHETERIZATION OF THE TARGET VESSEL OR MIGHT HAVE BEEN CAUSED BY THE BLUNT TIP OF THE CATHETER.
Patient problems: Vascular Dissection
MAUDE report 12249516 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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