Extractor™ Pro RX M00547040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729790273), received between Jun 17, 2020 and Jun 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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.

• MalfunctionJun 17, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, IT WAS NOTICED THAT A TRACE OF WATER-LIKE SUBSTANCE WAS INSIDE THE BALLOON. THERE WAS AN ATTEMPT TO INFLATE AND DEFLATE THE BALLOON; HOWEVER, THE BALLOON COULD NOT BE DEFLATED AND INSTEAD CONTINUED TO INFLATE. ADDITIONALLY, IT WAS NOTED THAT THE PHYSICIAN MIGHT HAVE ACCIDENTALLY INFLATED THE BALLOON WITH SALINE INSTEAD OF AIR BEFORE USING IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RX RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164983 ↗