AltaTrack AltaTrack GuidewireRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00884838070974), received between Jul 29, 2021 and Apr 15, 2026 — classified as 14 injuries.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ALTATRACK WIRE WAS USED FOR AN AORTIC PROCEDURE. DURING ADVANCEMENT OF THE ALTATRACK AND CATHETER, A DISSECTION WAS NOTED IN THE RIGHT RENAL ARTERY. ANGIOPLASTY WAS USED TO TREAT THE DISSECTION, AND THE PROCEDURE CONTINUED USING CONVENTIONAL TECHNIQUES. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK WAS IN USE WHEN A DISSECTION OCCURRED. THERE WAS NO ALLEGED MALFUNCTION WITH THE ALTATRACK WIRE.

  Patient problems: Vascular Dissection

  MAUDE report 24886830 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN AORTIC THERAPEUTIC PROCEDURE, AN ALTATRACK GUIDEWIRE WAS USED IN A SEVERELY TORTUOUS ANGULATED CELIAC ARTERY WITH MEDIAN ARCUATE LIGAMENT COMPRESSION. DURING USE, RESISTANCE WAS ENCOUNTERED WHEN TRYING TO PASS THE CURVE; THUS, THE GUIDEWIRE WAS REMOVED, AND A CONVENTIONAL EQUIPMENT WAS TRIED TO CANNULATE THE VESSEL. AFTER, ANGIOGRAPHY WAS PERFORMED, AND CONTRAST EXTRAVASATION WAS VISIBLE. THEREFORE, THE ARTERY WAS PLUGGED/COILED, AND A CUFF WAS PLACED INSIDE THE STENT GRAFT TO OCCLUDE THE PERFORATION. THE PATIENT WAS STABLE WITH NO FURTHER INTERVENTION REQUIRED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK GUIDEWIRE WAS IN USE WHEN A PERFORATION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE ALTATRACK GUIDEWIRE.

  Patient problems: Perforation of Vessels

  MAUDE report 21903093 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC T-BRANCH ENDOVASCULAR AORTIC REPAIRMENT PROCEDURE, AN ALTATRACK GUIDEWIRE WAS USED WITH A NON-PHILIPS ANGIOGRAPHIC CATHETER. THIS DID NOT WORK SUFFICIENTLY AS THE AIMED VESSEL DEPTH COULD NOT BE ATTAINED, AND A PROPER AND SAFE POSITIONING OF THE CATHETER COULD NOT BE ESTABLISHED BECAUSE THE CELIAC ARTERY TRUNK WAS VERY TORTUOUS AND HIGHLY CALCIFIED. THE ALTATRACK GUIDEWIRE VISUALIZATION WAS INTERMITTENTLY INTERRUPTED DUE TO BEND RADIUS ERRORS CAUSING THE GUIDEWIRE TIP TO HIT ANATOMICAL STRUCTURES AND LOSE SIGNAL. THIS REQUIRED FREQUENT INTERVALS TO CHECK THE GUIDEWIRE PLACEMENT UNDER FLUOROSCOPY. THE ALTATRACK GUIDEWIRE WAS EXCHANGED TO A CONVENTIONAL HYDROPHILIC ANGLED GUIDEWIRE (TERUMO) TO ESTABLISH A STABLE POSITION. THIS MANEUVER WAS CUMBERSOME, BUT SUCCESSFUL. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER SUPPORT FROM FORS TECHNOLOGY DUE TO THE HIGHLY CALCIFIED ANATOMIES OF THE TARGET VESSELS. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), BUT THE PATIENT'S CONDITION WORSENED SHORTLY AFTER. AN X-RAY WAS PERFORMED AND TWO HEMATOMAS WERE FOUND; ILIAC ARTERY (

  Patient problems: Perforation of Vessels

  MAUDE report 18041697 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC 4-FEVAR PROCEDURE, AN ALTATRACK GUIDEWIRE WAS USED WITH A NON-PHILIPS ANGIOGRAPHIC CATHETER. DURING NAVIGATION, FLUOROSCOPY CONFIRMED A STABLE POSITION IN THE MIDDLE OF THE VESSEL FOR A SAFE EXCHANGE TO AN INTERVENTIONAL GUIDEWIRE. THEREFORE, THE ALTATRACK GUIDEWIRE WAS REMOVED, BUT CONTRAST MEDIUM UNVEILED A SMALL DISSECTION IN THE MID CELIAC ARTERY TRUNK. THE DISSECTION WAS IMMEDIATELY CLOSED SUCCESSFULLY WITH A COVERED STENT. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK GUIDEWIRE CAUSED A DISSECTION, AND REQUIRED ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE ALTATRACK GUIDEWIRE.

  Patient problems: Vascular Dissection

  MAUDE report 17997772 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC 4-FEVAR PROCEDURE, AN ALTATRACK GUIDEWIRE WAS USED WITH A NON-PHILIPS ANGIOGRAPHIC CATHETER. DURING NAVIGATION, THE GUIDEWIRE CAUSED A PROMINENT DISSECTION IN THE DISTAL SEGMENT OF THE RIGHT RENAL ARTERY. A NON-PHILIPS COILING DEVICE WAS USED TO CREATE AN INTENTIONAL EMBOLIZATION TO OCCLUDE THE DAMAGED VESSEL, AND STOP THE DISTAL BLEEDING. THE PROCEDURE WAS CONTINUED WITH THE SAME DEVICES WITHOUT ANY FURTHER ISSUES. THE PATIENT IS IN STABLE CONDITION. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK GUIDEWIRE LIKELY CAUSED A DISSECTION, AND REQUIRED ADDITIONAL INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE ALTATRACK GUIDEWIRE.

  Patient problems: Vascular Dissection

  MAUDE report 17119491 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC AAA REPAIR PROCEDURE, A ALTATRACK BERENSTEIN CATHETER WAS DELIVERED OVER AN .035" ALTATRACK GUIDEWIRE. AFTER NAVIGATION, THE GUIDEWIRE LIKELY CREATED A DISSECTION PLAIN IN THE SMA, REQUIRING STENT PLACEMENT. THE PROCEDURE WAS COMPLETED WITH CONVENTIONAL DEVICES AND THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED AS EXPECTED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK GUIDEWIRE LIKELY CAUSED A DISSECTION, AND REQUIRED STENT PLACEMENT. THERE WAS NO ALLEGED MALFUNCTION WITH THE ALTATRACK GUIDEWIRE.

  Patient problems: Vascular Dissection

  MAUDE report 16906303 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC PROCEDURE, A .035" ALTATRACK GUIDEWIRE WAS USED IN A FEVAR PROCEDURE. DURING NAVIGATION IN THE RIGHT RENAL ARTERY, RESISTANCE WAS ENCOUNTERED AND UNABLE TO ADVANCE; THEREFORE, THE ALTATRACK GUIDEWIRE WAS SWAPPED WITH A NON-PHILIPS GUIDEWIRE. THE NON-PHILIPS GUIDEWIRE WAS ADVANCED FURTHER INTO THE RIGHT RENAL ARTERY, AND USING ANGIO, A DISSECTION WAS NOTED. THE PHYSICIAN BELIEVES THE DISSECTION WAS CAUSED BY THE ALTATRACK GUIDEWIRE. THE PHYSICIAN THEN CONTINUED TO CANNULATE THE LEFT RENAL ARTERY WITH A NON-PHILIPS CATHETER OVER AN ALTATRACK GUIDEWIRE, BUT RESISTANCE WAS NOTED. THUS, THE ALTATRACK GUIDEWIRE WAS SWAPPED WITH A NON-PHILIPS GUIDEWIRE. ANGIO WAS PERFORMED IN THE LEFT RENAL ARTERY WHEN A DISSECTION WAS NOTICED. THE PHYSICIAN WAS UNSURE WHICH GUIDEWIRE CAUSED THE DISSECTION. BOTH DISSECTIONS IN THE LEFT AND THE RIGHT RENAL ARTERIES WERE TREATED SUCCESSFULLY WITH VARIOUS TYPES OF STENTS. THE PATIENT WAS FINE AND DISCHARGED 3 DAYS POST PROCEDURE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK GUIDEWIRE MAY HAVE CAUSED A DISSECTION, AND REQUIRED STENT PLACEMENT.

  Patient problems: Vascular Dissection

  MAUDE report 16686824 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ALTATRACK GUIDEWIRE WAS USED IN A PERIPHERAL EVAR PROCEDURE. DURING NAVIGATION, A DISSECTION OCCURRED AND PERFORATED THE DISTAL LEFT RENAL ARTERY. THE DISSECTION RESOLVED ITSELF; THEREFORE, NO STENT PLACEMENT WAS REQUIRED. THE PATIENT WAS DISCHARGED AS NORMAL. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A DISSECTION OCCURRED. THERE WAS NO ALLEGED MALFUNCTION WITH THE ALTATRACK GUIDEWIRE.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 16576915 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC PROCEDURE, AN ALTATRACK CATHETER WAS LOADED OVER AN .035" ALTATRACK GUIDEWIRE USED IN A COMPLEX FEVAR PROCEDURE IN THE ABDOMINAL AORTA PLUS SIDE BRANCHES. DURING NAVIGATION OF THE RIGHT RENAL ARTERY, A DISSECTION OCCURRED, AND A SIGNIFICANT DECREASE IN BLOOD FLOW TO THE UPPER AND MIDDLE PORTION OF THE RIGHT KIDNEY WAS OBSERVED. TO TREAT THE DISSECTION, A BARE METAL STENT WAS IMPLANTED DISTAL TO THE COVERED STENT WITH IMPROVED BLOOD FLOW. THE PATIENT WAS DISCHARGED AS EXPECTED, 3 DAYS POST-PROCEDURE. THE PHYSICIAN CONFIRMED THAT THE DISSECTION WAS RELATED TO THE GUIDEWIRE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK GUIDEWIRE CAUSED A DISSECTION, AND REQUIRED STENT PLACEMENT.

  Patient problems: Vascular Dissection

  MAUDE report 16524215 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COMPLEX AORTIC ANEURYSM REPAIR (FEVAR) PROCEDURE, A CONVENTIONAL CATHETER WAS LOADED OVER AN ALTATRACK GUIDEWIRE. DURING ADVANCEMENT, THE GUIDEWIRE KINKED. WHILE CANNULATING IN THE CELIAC TRUNK, A MILD DISSECTION OCCURRED, AND COVERED WITH A STENT. THE PATIENT WAS DISCHARGED AS EXPECTED. IT WAS NOTED THAT THE KINK DID NOT CONTRIBUTE TO THE DISSECTION. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A DISSECTION OCCURRED AND REQUIRED STENT PLACEMENT.

  Patient problems: Vascular Dissection

  MAUDE report 15891068 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AN ALTATRACK GUIDEWIRE WAS USED IN A BEVAR PROCEDURE IN THE ABDOMINAL AORTA PLUS SIDE BRANCHES. THE ALTATRACK GUIDEWIRE WAS USED ALONG WITH NON-PHILIPS CONVENTIONAL GUIDEWIRES IN COMBINATION WITH CONVENTIONAL CATHETERS. NO PATIENT INJURY OR DEVICE MALFUNCTION WAS REPORTED AT THE TIME OF THE PROCEDURE. HOWEVER, 8 DAYS POST PROCEDURE ON (B)(6) 2021, A DISSECTION WAS NOTED IN THE DESCENDING AORTA (CELIAC TRUNK, STENOTIC >50%, NOT CALCIFIED <50%), BUT NO INTERVENTION WAS PERFORMED. THIS ADVERSE EVENT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION BECAUSE IT COULD NOT BE DETERMINED IF THE ALTATRACK GUIDEWIRE CAUSED OR CONTRIBUTED TO THE DISSECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 15846300 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC PROCEDURE, A ALTATRACK BERENSTEIN CATHETER WAS LOADED OVER AN ALTATRACK GUIDEWIRE. WHILE CANNULATING IN THE LEFT RENAL ARTERY, A DISSECTION OCCURRED. THE LESION WAS WIRED WITH AN 0.014" NON-MANUFACTURER'S'S SUPPORT WIRE AND COVERED WITH A STENT. THERE WAS NO DEVICE MALFUNCTION REPORTED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE A DISSECTION OCCURRED AND REQUIRED STENT PLACEMENT.

  Patient problems: Vascular Dissection

  MAUDE report 15677316 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL THERAPEUTIC PROCEDURE, A ALTATRACK BERENSTEIN CATHETER WAS LOADED OVER AN ALTATRACK GUIDEWIRE. DURING ADVANCEMENT, RESISTANCE WAS ENCOUNTERED WHILE CANNULATING IN THE RIGHT RENAL ARTERY. A DISSECTION WAS NOTED, WHICH WAS THEN COVERED WITH A STENT. THE PHYSICIAN STATED THAT THE GUIDEWIRE CAUSED THE DISSECTION, BUT THERE WAS NO DEVICE MALFUNCTION. THE PATIENT WAS PRESUMED IN STABLE CONDITION AND DISCHARGED FROM THE HOSPITAL. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE ALTATRACK GUIDEWIRE CAUSED A DISSECTION AND REQUIRED STENT PLACEMENT.

  Patient problems: Vascular Dissection

  MAUDE report 15601895 ↗
• 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 12249559 ↗