Extractor™ Pro RX M00547030Recalls & reported problems
Boston Scientific Corporation · Retrieval Balloon Catheter · Class 2
All models of Extractor Pro RX (6)
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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729790280), received between May 10, 2023 and May 10, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Recalls naming this device
- Aug 28, 2025Open, Classified
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Z-2618-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1
- 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.
InjuryMay 10, 2023Break; Difficult to Advance; Break; Difficult to Advance
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXTRACTOR PRO RX RETRIEVAL BALLOON WAS USED IN COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON WAS DIFFICULT TO PASS DOWN THE SCOPE. THE CATHETER WAS NOTED TO SNAP IN HALF IN THE PATIENT'S COMMON BILE DUCT. THE CUSTOMER STATED THAT THEY NEED TO SWEEP THE BALLOON FRAGMENT OUT OF THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELLED AFTER THE PATIENT HAD BEEN SEDATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16908156 ↗
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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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