Echelon 145-5091-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00836462002340), received between Jan 4, 2021 and Jan 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K093750); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHILE INSERTING THE AXIUM PRIME BARE 3D COIL INTO THE ECHELON 45° CATHETER, AN UNUSUAL RESISTANCE WAS NOTED. SIMILAR RESISTANCE WAS ALSO FELT DURING THE REMOVAL. COIL RESISTANCE/STUCK WITHIN SHEATH WAS ALSO REPORTED. UPON INSPECTION AFTER REMOVAL, THE FORMATION OF A KNOT-LIKE STRUCTURE WAS OBSERVED. THE COIL WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANTERIOR COMMUNICATING ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED: ASAHI FUBUKI GUIDECATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201434 ↗
• MalfunctionSep 10, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE GUIDEWIRE PUNCTURE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185522 ↗
• MalfunctionAug 5, 2024Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER WAS PUNCTURED WITH THE GUIDEWIRE/STYLET IN THE DISTAL SECTION. THE PATIENT WAS UNDER COIL TREATMENT FOR A DURAL ARTERIOVENOUS MALFORMATION. THE ACCESSED VESSEL WAS THE EXTERNAL JUGULAR VEIN WITH A DIAMETER OF 1 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING TREATMENT FOR THE DURAL ARTERIOVENOUS SPUTUM, THE WIRE PROTRUDED FROM THE TIP MARKER OF THE CATHETER BEFORE INSERTION OF THECOIL DUE TO TAE, AND IT WAS DEEMED ABNORMAL, SO IT WAS REPLACED. IT WAS REPORTED CATHETER PERFORATION (WITH GUIDEWIRE/STYLET) OCCURRED IN THE DISTAL SHAFT. THERE WAS NO RESISTANCE WHEN PASSING THE GUIDEWIRE/STYLET. THERE WERE NO KINKED OR OTHER DAMAGE ON THE GUIDEWIRE, COIL, OR STYLET. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906432 ↗
• MalfunctionMay 10, 2024Difficult to Advance; Material Integrity Problem; Unintended Movement; Physical Resistance/Sticking; Difficult to Advance; Material Integrity Problem; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT VESSEL TORTUOSITY WAS MODERATE. THE PATIENT HAD NO PROBLEMS RECOVERING FROM THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287348 ↗
• MalfunctionMay 4, 2022Leak/Splash; Device Dislodged or Dislocated; Material Deformation; Leak/Splash; Device Dislodged or Dislocated; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT A ECHELON CATHETER TIP WAS TORN DURING SETUP WHEN SHAPING THE TIP. NO PATIENT WAS INVOLVED WITH THIS EVENT. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS RUPTURED AT THE DISTAL SHAFT. THE PRODUCT BOX WAS NOT DAMAGED. THERE WAS NO TRACES OF THE PRODUCT BEING OPENED PRIOR TO USE. THERE WAS NO RESISTANCE DURING INJECTION. THERE WAS NO ADHESION OR STUCK OF THE CATHETER TIP. NO VASOSPASM. IT WAS NOT STUCK IN THE GUIDING CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14275414 ↗
• MalfunctionJan 4, 2021Device Damaged by Another Device; Physical Resistance/Sticking; Device Damaged by Another Device; Physical Resistance/Sticking

  MEDTRONIC RECEIVER A REPORT THAT THE MICROCATHETER WAS PROMINENT, WITH IT FOUND THAT THERE WAS A HOLE IN THE DISTAL MARK OF THE DEVICE. IT WAS NOT CONFIRMED IF THE PUNCTURE WAS RELATED TO THE GUIDEWIRE, BUT THE GUIDEWIRE WAS PROTRUDING FROM THE HOLE. THE PATIENT WAS UNDERGOING TREATMENT OF AN ANEURYSM. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MODERATE AND THAT THE DEVICES WERE PREPARED AND FLUSHED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. THERE WAS NO OTHER DAMAGE SEEN TO THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108466 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093750. One submission often covers many models, so check the product and lot details in each record.

• Z-1557-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
• Z-1556-2022 · Jun 30, 2022 · Open, Classified
  Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only