Expo™ H74908526021Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729366461), received between Mar 18, 2019 and Apr 3, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 21, 2024Class IOpen, Classified

   An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

   Z-1639-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING PREPARATION, WHILE PASSING THE WIRE THROUGH THE EXPO CATHETER, A WHITE PIECE CAME OUT FROM CATHETER AND ATTACHED TO DISTAL PORTION OF THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034431 ↗
• InjuryApr 1, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER BROKE OFF IN THE PATIENT AND THEY REQUIRED SURGICAL INTERVENTION TO REMOVE IT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DISTAL HALF TO TWO THIRDS OF THE SEPARATED CATHETER WERE WHAT WAS STUCK INSIDE THE PATIENT'S ARM JUST ABOVE THE BRACHIAL AREA UP THROUGH THE SUBCLAVIAN ARTERY AREA. THE DEVICE BECAME SO TWISTED BUT IT APPEARS TO HAVE DETACHED UPON ATTEMPTS TO REMOVE IT FROM THE BODY. AFTER WHICH IT BROKE OFF AND HAD TO BE SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015890 ↗
• MalfunctionNov 13, 2023Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 5F EXPO DIAGNOSTIC GUIDE CATHETER WAS SELECTED FOR USE IN A DIAGNOSTIC ANGIOGRAM PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE WAS STUCK INSIDE THE CATHETER AND CAUSED THE CATHETER TO FRAY. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18128070 ↗
• MalfunctionNov 13, 2023Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 5F EXPO DIAGNOSTIC GUIDE CATHETER WAS SELECTED FOR USE IN A DIAGNOSTIC ANGIOGRAM PROCEDURE. DURING THE PROCEDURE, THE GUIDEWIRE WAS STUCK INSIDE THE CATHETER AND CAUSED THE CATHETER TO FRAY. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18128068 ↗
• MalfunctionOct 11, 2023Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS NOTED. A 5F EXPO DIAGNOSTIC GUIDE CATHETER WAS SELECTED FOR USE IN A DIAGNOSTIC ANGIOGRAM PROCEDURE. DURING PREPARATION, THE PHYSICIAN WAS NOT ABLE TO ADVANCE A STARTER GUIDEWIRE THROUGH THE CATHETER. WHEN THEY DECIDED TO BACKLOAD THE WIRE, A PLASTIC PIECE WAS LODGED INSIDE THE CATHETER. THEY WERE ABLE TO PUSH THE PLASTIC OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914623 ↗
• InjuryJan 19, 2022Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT CATHETER BREAK AND VASCULAR DISSECTION OCCURRED. THE PATIENT PRESENTED FOR LEFT HEART CATHETERIZATION. THE EXPO GUIDE CATHETER WAS ENTERED RIGHT ANTECUBITAL. WHEN THE EXAM WAS COMPLETED AND THE CATHETER WAS BEING WITHDRAWN THERE WAS A LOSS OF WAVEFORM AND A POSSIBLE KINK WAS NOTICED. SEVERAL WITHDRAWAL ATTEMPTS WERE MADE AND IT WAS THEN NOTICED THE CATHETER WAS OUT OF THE ARTERY. THE CATHETER HAD BROKEN OFF AND PUNCTURED THE ARTERY. THE PATIENT WAS IMMEDIATELY TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE DEVICE FRAGMENT FROM THE RIGHT BRACHIAL ARTERY. A CUTDOWN WAS PERFORMED AND THE SAPHENOUS VEIN BYPASS REVERSED. THE CATHETER WAS RETRIEVED AND THE PATIENT DISCHARGED THE NEXT MORNING.

  Patient problems: Vascular Dissection

  MAUDE report 13297118 ↗
• InjuryDec 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE DIAGNOSTIC EXPO FR4 DISTAL SEPARATED FROM MAIN SHAFT IN THE SHEATH. A MODEL-5F EXPO FR4 (5PK) EXPO GUIDE CATHETER WAS ADVANCED FOR TREATMENT; HOWEVER, THE CATHETER SEPARATED WHILE IN THE SHEATH. MULTIPLE SNARES WERE ATTEMPTED TO REMOVE THE FRAGMENT. THE CATHETER FRAGMENT REMAINED IN THE PATIENT'S ARM. THE PATIENT WAS TAKEN TO SURGERY AND A BYPASS GRAFT IN THE ARM WAS PLACED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13017969 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING A DIAGNOSTIC HEART CATHETERIZATION AS THEY WERE SHOOTING THE LEFT INTERNAL MAMMARY ARTERY (LIMA), FLOW LIMITING DISSECTION OCCURRED. STENTS WERE USED TO TREAT THE DISSECTION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 8429728 ↗