NaviFlex™ Pusher M00535030Recalls & reported problems
Boston Scientific Corporation · Long Wire Pusher · Class 2 · Implant
Data updated Oct 18, 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.
Quick summary
This Boston Scientific NaviFlex Long Wire Pusher is a tool used with biliary catheters. The 26 reports mostly describe a packaging mix-up where boxes labeled for the long-wire version contained the short-wire version instead, found before use, with no deaths and no injuries. No recalls name this device, with 25 reports in the last 12 months compared with 0 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08714729856191), received between Aug 8, 2024 and Sep 29, 2026 — classified as 46 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (45 reports).
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 18, 2026.
Reports received per month
Recalls naming this device
- Sep 10, 2026Open, Classified
Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
Z-0143-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Markings/Labelling Problem45
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935762 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935402 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
It was reported to Boston Scientific Corporation that a NaviFlex LongWire Pusher was to be used during an Endoscopic Retrograde Biliary Drainage (ERBD) procedure performed on (b)(6) 2026.A different product was found inside the packaging of the purchased item. The previously used product was the "Long Wire type" where the guidewire passes straight through the inlet and outlet. However, the product received that time was identified as the "RX type," in which the guidewire exits through a port on the side of the catheter body. The product is unopened and was not used on a patient.There were no patient complications reported as a results of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935399 ↗MalfunctionSep 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935346 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216465 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216459 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216452 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216451 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216449 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216448 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214674 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214673 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211016 ↗MalfunctionAug 11, 2026Device Markings/Labelling Problem
Note: Related Naviflex Long Wire Pusher complaints are reported under records: (b)(4). It was reported to Boston Scientific Corporation that labeling discrepancy was identified: the package was labeled as a long wire pusher; however, the device inside was a short wire pusher. It was also determined that the product used had a side-hole feature. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210996 ↗MalfunctionAug 5, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144705 ↗MalfunctionJul 31, 2026Device Markings/Labelling Problem
Note: Related Naviflex Long Wire Pusher complaints are reported under records (b)(4). It was reported to Boston Scientific Corporation that a Naviflex Long Wire Pusher was to be used during an unknown procedure performed on (b)(6) 2026. During preparation for the procedure, a labeling discrepancy was identified. The package was labeled as a Long Wire Pusher; however, the device contained within the package was a Short Wire Pusher. The product previously used by the facility was a long-wire type, in which the guidewire passes directly through the inlet and outlet. The product received on this occasion was confirmed to be an RX type, in which the guidewire exits through a side port located on the outer sheath. There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098887 ↗MalfunctionJul 31, 2026Device Markings/Labelling Problem
Note: Related Naviflex Long Wire Pusher complaints are reported under records (b)(4)and (b)(4).It was reported to Boston Scientific Corporation that a Naviflex Long Wire Pusher was to be used during an unknown procedure performed on (b)(6)l 2026. During preparation for the procedure, a labeling discrepancy was identified. The package was labeled as a Long Wire Pusher; however, the device contained within the package was a Short Wire Pusher. The product previously used by the facility was a long-wire type, in which the guidewire passes directly through the inlet and outlet. The product received on this occasion was confirmed to be an RX type, in which the guidewire exits through a side port located on the outer sheath. There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098885 ↗MalfunctionJul 31, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098877 ↗MalfunctionJul 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070859 ↗MalfunctionJul 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070854 ↗MalfunctionJul 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070714 ↗MalfunctionJul 29, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070713 ↗MalfunctionJul 22, 2026Device Markings/Labelling Problem
Note: This report pertains to one of two NaviFlex LongWire Pusher device used in the same procedure.It was reported to Boston Scientific Corporation that two NaviFlex LongWire Pusher was used in the pancreatic duct to treat an obstruction during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.During the procedure, while advancing the pusher over the guidewire, the user noticed that it was a short-wire pusher. A second pusher was opened and found to be the same. The procedure was completed using a different device.There were no patient complications reported as a results of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25908078 ↗MalfunctionJul 22, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25908062 ↗MalfunctionJul 16, 2026Device Markings/Labelling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25841630 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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