GUIDELINER IPN913568Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841156100605), received between Jul 22, 2019 and Apr 2, 2025 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "WHEN DELIVERING A DEVICE INTO THE GUIDELINER, THE GUIDELINER GOT BROKEN/CUT. THEREFORE, THE GUIDELINER WAS REMOVED AND REPLACED WITH ANOTHER DEVICE OF THE OTHER COMPANY TO COMPLETE THE PROCEDURE." NO INJURY TO THE PATIENT OCCURRED. THE DEVICE THAT WAS BEING DELIVERED IN THE GUIDELINER. THE DEVICE THAT WAS REPLACED FROM THE GUIDELINER TO COMPLETE THE PROCEDURE. THE PATIENT INFORMATION (GENDER, AGE, WEIGHT, ETC.) IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751386 ↗
• InjuryJun 24, 2021Malposition of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  AS REPORTED: GUIDELINER IN LEFT CX ARTERY DISSECTED VESSEL. PER TECH: "THE PATIENT IS FINE. IT WAS A VERY TORTUOUS VESSEL LOTS OF CALCIUM WITH NO SUPPORT FROM THE GUIDE. THE STENT CAME OFF THE BALLOON. THE GUIDELINER WAS SEATED PRETTY FAR IN THE VESSEL. PATIENT WAS SENT TO SURGERY.

  Patient problems: Vascular Dissection

  MAUDE report 12060359 ↗
• InjuryApr 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A PTCA WITH RADIAL APPROACH, WITH A DIFFICULT GUIDING CATHETER CANNULATION, THE PHYSICIAN DECIDED TO USE A GUIDELINER V3 6FR INTO THE GUIDING CATHETER AND REPORTED EXCESSIVE FRICTION BUT FINALLY IT WAS DELIVERED, AND STENT WAS SUCCESSFULLY IMPLANTED. DURING THE PROCEDURE AND PUSHING MANEUVERS, PATIENT REPORTED PAIN IN THE ACCESS. REPORTED NO MEDICAL INTERVENTION AND CURRENT PATIENT CONDITION IS FINE.

  Patient problems: Intraoperative Pain

  MAUDE report 11628674 ↗
• DeathOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER MEDWATCH RECEIVED 29SEP2020 MEDWATCH UF_IMPORTER (B)(4). (B)(4) FROM STAFF: DURING CORONARY INTERVENTION A STENT WAS DEPLOYED CAUSING A TEAR IN THE VESSEL. WE ATTEMPTED THE DELIVERY OF A STENT HOWEVER WERE UNSUCCESSFUL. UPON REMOVAL OF THE COVERED PORTION OF THE STENT WAS NOT PRESENT ON THE STENT. UPON FURTHER INVESTIGATION IT IS BELIEVED TO HAVE FALLEN OFF INTO THE PATIENT'S CORONARY VESSEL WITHOUT BEING DEPLOYED. THUS, MADE FURTHER INTERVENTION IMPOSSIBLE TO HAPPEN DUE TO INABILITY TO PASS THE EQUIPMENT. FROM PHYSICIAN: PATIENT WAS RECENTLY POST CARDIAC SURGERY WITH 3 VEIN GRAFTS PLACED TO HER HEART ARTERIES, DURING SURGERY THERE WAS DAMAGE TO THE LEFT ANTERIOR DESCENDING (LAD), WHICH WAS REPAIRED IN THE OR DISTAL TO THE ATTACHMENT OF THE VEIN GRAFT. THE ARTERY DID NOT STAY OPEN AND CLOSED LIKELY THE NIGHT OF THE SURGERY, THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY UNSTABLE AND WITH VENTRICULAR TACHYCARDIA AND WITH ELECTROCARDIOGRAM CHANGES SUGGESTIVE OF A CARDIAC INFARCTION. WE TOOK THE PATIENT EMERGENTLY TO THE CATHERIZATION LAB AND NOTED THAT THE LAD SEGMENT DISTAL TO THE FRESHLY PLACED GRAFT WAS OCCLUDED, WE TRIED OPENING THE SEGMENT WITH A BALLOON, BUT THE RESULT WAS SUB

  Patient problems: Insufficient Information

  MAUDE report 10738068 ↗
• MalfunctionOct 15, 2020Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED: STARTED TO LOAD GUIDELINER V3 ONTO WIRE WHEN "HYPO TUBE" CAUGHT ON VALVE. PHYSICIAN NOTICED THAT WITH EACH PUSH, THE BACK DARK BLUE PLASTIC PIECE THAT EXTENDS FROM "TUBE" ONTO WIRE, STARTED TO COME OFF WIRE. DEVICE NEVER MADE IT INTO BODY, OR GUIDE, SO NO INTERVENTION NEEDED TO RETRIEVE ANYTHING. NO HARM DUE TO DEVICE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10686362 ↗
• InjuryJul 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ORBITAL THROMBECTOMY CASE THE DEVICE WAS LODGED. THE PHYSICIAN ATTEMPTED TO SLIDE A GUIDELINER OVER THE LODGED DEVICE WHEN THE GUIDELINER DISLODGED FROM THE PUSHROD. OTHER CHARACTERISTICS OR MEDICAL CONDITIONS; MULTIPLE STENTS WITH IN-STENT STENOSIS. INFORMATION PER MEDWATCH UF / IMPORTER (B)(4) RECEIVED 24JUN2019: DURING CORONARY INTERVENTION / ARTHRECTOMY OF RIGHT CORONARY ARTERY THE ROTABLATOR BURR BECAME LODGED IN THE ARTERY AND COULD NOT BE ADVANCED FORWARD OR BACKWARDS. IT WAS THEN DISCOVERED THAT THE BURR BROKE OFF THE DEVICE AND REMAINED LODGED IN THE ARTERY. FOR FEAR OF FURTHER INJURY TO THE ARTERY, THE PHYSICIAN DISCONTINUED RETRIEVAL ATTEMPTS AND DECIDED TO USE A GUIDELINER CATHETER TO RETRIEVE LODGED BURR. UNFORTUNATELY, THEN THE TIP OF THE GUIDELINER CATHETER BROKE OFF IN THE VESSEL AND EVENTUALLY ENDED UP IN THE ASCENDING AORTA. SURGICAL BACK UP WAS CALLED AND THE CARDIOVASCULAR SURGEON TOOK THE PATIENT TO THE OPERATING ROOM FOR A RIGHT CORONARY ARTERY BYPASS FOR REMOVAL OF THE RETAINED FOREIGN OBJECTS. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE TIME. FOLLOWING SURGERY, THE PATIENT WAS ADMITTED TO CRITICAL CARE AND IS STABLE AT THIS POINT. ADDITIONAL

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8811416 ↗