Extractor™ Pro RX-S M00547320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729907176), received between Dec 10, 2018 and Aug 22, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON WAS DEFORMED WHEN IT WAS INFLATED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15267917 ↗
• MalfunctionDec 10, 2018Entrapment of Device; Problem with Sterilization; Contamination /Decontamination Problem; Entrapment of Device; Problem with Sterilization; Contamination /Decontamination Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE EXTRACTOR PRO BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON DEVICE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PART OF AN EXTRACTOR DEVICE DETACHED AND WAS MISTAKENLY LEFT INSIDE THE SCOPE. ON (B)(6) 2017, DURING A SEPARATE PROCEDURE, A FOREIGN OBJECT WAS NOTED TO BE STUCK INSIDE THE ENDOSCOPE AND BLOCKED THE PASSAGE. REPORTEDLY, THE FOREIGN OBJECT FOUND IN THE SCOPE WAS THE PART OF AN EXTRACTOR BALLOON THAT WAS USED FROM THE PREVIOUS PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147694 ↗
• MalfunctionDec 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE EXTRACTOR PRO BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RX-S RETRIEVAL BALLOON DEVICE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PART OF AN EXTRACTOR DEVICE DETACHED AND WAS MISTAKENLY LEFT INSIDE THE SCOPE. ON (B)(6) 2017, DURING A SEPARATE PROCEDURE, A FOREIGN OBJECT WAS NOTED TO BE STUCK INSIDE THE ENDOSCOPE AND BLOCKED THE PASSAGE. REPORTEDLY, THE FOREIGN OBJECT FOUND IN THE SCOPE WAS THE PART OF AN EXTRACTOR BALLOON THAT WAS USED FROM THE PREVIOUS PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147305 ↗