Expo™ H74908526211Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729366607), received between Aug 16, 2019 and Apr 29, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 21, 2024Open, 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-1653-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE END PIECE IS BREAKING LOOSE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209852 ↗
• MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE END PIECE IS BREAKING LOOSE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209842 ↗
• MalfunctionApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE END PIECE IS BREAKING LOOSE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209836 ↗
• MalfunctionFeb 8, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN THE DEVICE. AN EXPO DIAGNOSTIC CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS ADVANCED IN PATIENT. HOWEVER, AN ATTEMPT TO LOAD THE WIRE, THE WIRE WAS NOT SUCCESSFUL DUE TO A WHITE PLASTIC PIECE BEING LODGED IN THE CATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667814 ↗
• MalfunctionJan 12, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE DEVICE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS UNABLE TO ADVANCE THROUGH THE CATHETER. FURTHERMORE, A PIECE OF PLASTIC WAS NOTED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502504 ↗
• MalfunctionJan 12, 2024Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE DEVICE. AN EXPO GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO LOAD THE WIRE, IT WAS NOTED THAT THE WIRE WAS UNABLE TO ADVANCE THROUGH THE CATHETER. FURTHERMORE, A PIECE OF PLASTIC WAS NOTED BLOCKING INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502129 ↗
• MalfunctionDec 27, 2023Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE DEVICE. TWO 5F EXPO GUIDE CATHETERS WERE SELECTED FOR USE. DURING THE PROCEDURE, BEFORE THE CATHETER ENTERED THE PATIENT, IT WAS NOTED THAT THE GUIDEWIRE WOULD NOT LOAD THRU THE DIAGNOSTIC CATHETER. THE GUIDEWIRE WAS GETTING STUCK IN THE MIDDLE OF THE BODY OF THE CATHETER. A SECOND CATHETER WAS OPENED, AND THE SAME ISSUE OCCURRED. THE CATHETERS WERE THEN CUT OPEN AND A WHITE PLASTIC FOREIGN MATERIAL WAS FOUND TO BE OCCLUDING THE LUMEN OF THE CATHETERS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406515 ↗
• MalfunctionDec 27, 2023Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE DEVICE. TWO 5F EXPO GUIDE CATHETERS WERE SELECTED FOR USE. DURING THE PROCEDURE, BEFORE THE CATHETER ENTERED THE PATIENT, IT WAS NOTED THAT THE GUIDEWIRE WOULD NOT LOAD THRU THE DIAGNOSTIC CATHETER. THE GUIDEWIRE WAS GETTING STUCK IN THE MIDDLE OF THE BODY OF THE CATHETER. A SECOND CATHETER WAS OPENED, AND THE SAME ISSUE OCCURRED. THE CATHETERS WERE THEN CUT OPEN AND A WHITE PLASTIC FOREIGN MATERIAL WAS FOUND TO BE OCCLUDING THE LUMEN OF THE CATHETERS. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406509 ↗
• MalfunctionDec 5, 2023Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS PRESENT IN THE DEVICE LUMEN. A5F EXPO FL3.5 DIAGNOSTIC CATHETER WAS SELECTED FOR USE. A 0.035-INCH NON-BOSTON SCIENTIFIC (NON-BSC) WIRE WAS INTRODUCED THROUGH THE CATHETER OUTSIDE THE PATIENT, BUT THE WIRE WOULD NOT ADVANCE NEAR THE FIRST AND SECOND DEVICE CURVES. WHEN MORE EFFORT WAS APPLIED, SUDDENLY THE WIRE ADVANCED OUT THE TIP OF THE EXPO CATHETER AND A LARGE WHITE CHUNK OF PLASTIC DEBRIS EXITED THE CATHETER. THE SAME THING OCCURRED WITH A 5F EXPO FL4 DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268269 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISSECTION. THE TARGET LESION WAS LOCATED IN LEFT HEART. A 5F EXPO GUIDE CATHETER WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IMAGING WAS PERFORMED AND EVERYTHING LOOKED FINE. THE 5F EXPO GUIDE CATHETER WAS USED. WHEN THE SECOND SET OF IMAGING WAS COMPLETED AFTER USING THIS DEVICE, A DISSECTION WAS OBSERVED. INTERVENTION WAS PERFORMED WITH BALLOONS AND STENTS. THE PROCEDURE WAS COMPLETED WITH MEDICAL INTERVENTION. THE CASE WAS COMPLETED AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 8901391 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISSECTION. THE TARGET LESION WAS LOCATED IN LEFT HEART. A 5F EXPO GUIDE CATHETER WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IMAGING WAS PERFORMED AND EVERYTHING LOOKED FINE. THE 5F EXPO GUIDE CATHETER WAS USED. WHEN THE SECOND SET OF IMAGING WAS COMPLETED AFTER USING THIS DEVICE, A DISSECTION WAS OBSERVED. INTERVENTION WAS PERFORMED WITH BALLOONS AND STENTS. THE PROCEDURE WAS COMPLETED WITH MEDICAL INTERVENTION. THE CASE WAS COMPLETED AND THE PATIENT WAS FLOWN TO ANOTHER HOSPITAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 8901390 ↗