Expo™ H74908526401Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729366713), received between May 27, 2020 and Jan 27, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A THROMBUS PRESENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 24MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. 10,00 UNITS OF HEPARIN WAS GIVEN PRIOR TO THE TRANSEPTAL PUNCTURE. THE TRANSSEPTAL PUNCTURE WAS THEN COMPLETED AND THE PHYSICIAN POSITIONED THE WAS IN THE LAA OF THE PATIENT. A SECOND DOSE OF 10,000 UNITS OF HEPARIN WAS GIVEN AFTER THE TRANSSEPTAL PUNCTURE. THE WDS WAS PREPARED, AND THE EXPO PIGTAIL CATHETER WAS REMOVED BUT CAME OUT WITH A THROMBUS PRESENT. THE PHYSICIAN REMOVED THE WAS AND ALL PRODUCTS FROM THE PATIENT. AN ADDITIONAL 10,000 UNITS OF HEPARIN WAS GIVEN TO THE PATIENT, AND THE PROCEDURE WAS CONTINUED WITH ALL NEW PRODUCTS. THE PROCEDURE WAS COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WILL BE OBSERVED FOR SIX (6) HOURS POST PROCEDURE AND THEN BE DISCHARGED HOME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21242082 ↗
• MalfunctionMay 27, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS OBSERVED A MODEL 5F WAS PREPPED FOR USE TO VIEW THE TARGET LESION. PHYSICIAN NOTICED CATHETER HAD A PLASTIC PIECE ADHERED TO THE HUB. THEY WERE UNABLE TO USE IT. IT DID NOT GO INTO THE BODY, AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10092175 ↗