NA M0062602500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729137122), received between Oct 3, 2017 and Oct 3, 2017 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ SHEATH DILATOR SET WAS UNPACKED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, A FOREIGN OBJECT WAS NOTED TO BE PRESENT INSIDE THE STERILE PACKAGE. THEY DISCONTINUED ON USING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER AMPLATZ SHEATH DILATOR SET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED AS "NO CONSEQUENCES".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6910134 ↗