Expo™ H74908526221Recalls & reported problems
Boston Scientific Corporation · Angiographic Catheter · Class 2
All models of Expo (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729366638), received between Dec 5, 2023 and Dec 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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 16, 2026.
Reports received per month
Recalls naming this device
- 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-1655-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 18268285 ↗
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- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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