Echelon 105-5091-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00836462002241), received between Nov 16, 2020 and May 5, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A NON-MEDTRONIC 1.5 MM/3 MM COIL WAS SUCCESSFULLY EMBOLIZED USING AN ECHELON 10 MICROCATHETER, HOWEVER, THE SECOND AND SUBSEQUENT NON-MEDTRONIC 1 MM/2 CM AND 1 MM/1 CM COILS GOT CAUGHT INSIDE THE EXTENSION HUB OF THE EXTENSION, AND THE COIL COULD NOT ENTER THE MICROCATHETER. IT WAS ALSO REPORTED THAT THERE WERE NO DEVICE MALFUNCTIONS. AS SUCH, ONLY ONE LEAD (COIL) WAS INSERTED, AND 3 LEADS (COILS) COULD NOT BE DELIVERED. THE PROCEDURE WAS COMPLETED BECAUSE THE IMPLANT COULD NOT BE PERFORMED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF A HEMATOCEPHALUS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED TERUMO HYDROSOFT3D (1.5 MM/3 CM) COIL (MV-01503HHTA, LOT: 0001018065), HYPERSOFT 3D (1 MM/2 CM) COIL (LOT: 0000215361), AND KANEKA ED (1 MM/1 CM) COIL 2 (LOT: KR075028, KR965283). ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE LESION CHARACTERISTICS PROVIDED WAS AN IC-C2 (INTRACRANIAL C2). THE VESSEL TO RTUOSITY WAS NORMAL. THE PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086210 ↗
• MalfunctionAug 17, 2023Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE ECHELON WAS STEAMED, AN ATTEMPT WAS MADE TO SET UP A SYNCHRO SELECT STANDARD 14 WIRE AND THE 14 WIRES WERE PERFORATED AT A POINT AROUND 1CM FROM THE DISTAL TIP OF THE ECHELON. THE ECHELON WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE ECHELON AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR ANEURYSM COIL EMBOLIZATION. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA) WITH A DIAMETER OF 4MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A SYNCHRO SELECT STANDARD 14 WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568305 ↗
• MalfunctionDec 9, 2022Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT "IC-AN" REFERRED TO AN INTERNAL CAROTID ARTERY ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15953785 ↗
• MalfunctionNov 15, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SIZE OF THE M1 DISTAL ANEURYSM WAS JUST UNDER 5MM. THE IC SIPHON REGION WAS BENT TO A NORMAL LEVEL. THE PATIENT HAD NO PROBLEMS RECOVERING FROM THE PROCEDURE AND DID NOT EXPERIENCE ANY SYMPTOMS. THE CONNECTION BETWEEN THE MARKER AND THE CATHETER BODY WAS BROKEN. THE CAUSE OF THE BREAKAGE AND RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15802730 ↗
• MalfunctionOct 18, 2022Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SHAFT OF THE ECHELON 10 MICROCATHETER WAS PERFORATED BY THE GUIDEWIRE DURING SETUP. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM LOCATED IN THE MIDDLE CEREBRAL ARTERY. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE INTERNAL CAROTID-MIDDLE CEREBRAL ARTERY, WHICH WAS 2-4MM IN DIAMETER. IT WAS REPORTED THAT THE STEAM SHAPE WAS APPLIED TO THE J MODEL OF THE ECHELON 10 FOR 30 SECONDS. AFTER THE SHAPING, AN ATTEMPT WAS MADE TO SET UP A GUIDEWIRE. THE GUIDEWIRE PERFORATED AT A POINT IN THE VICINITY OF 1 CM AT THE TIP OF THE ECHELON. A REPLACEMENT ECHELON WAS USED WITHOUT ANY PROBLEMS, AND COIL EMBOLIZATION WAS COMPLETED. THERE WAS NO RESISTANCE WHEN PASSING THE GUIDEWIRE, AND IT WAS NOT KINKED. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A SYNCHRO SELECT STANDARD 14 GUIDEWIRE AND A SOFIA 6FR GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621116 ↗
• MalfunctionSep 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT AN ECHELON CATHETER WAS NOT VISIBLE. ONLY THE TIP MARKER COULD NOT BE VISUALLY CONFIRMED WHEN IT WAS RUN ALONGSIDE THE GUIDEWIRE AND DELIVERED THE CORRESPONDING PRODUCT, ESTRON 10, TO THE FRONT OF THE LESION REGION. THE ATTENDING PHYSICIAN AS WELL AS THE SALES REPRESENTATIVE OF A DISTRIBUTOR WHO WAS PRESENT COULD NOT VISUALLY CONFIRM THE EVENT. IT WAS DETERMINED TO BE A DEFECT, SO IT WAS COLLECTED AND RESOLVED WITH THE SAME MODEL. THE DEVICE WAS PREPARED AS INDICATED IN HE PACKAGE INSERT. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT.  ANCILLARY DEVICES: CHIKAI AIN-CKI-200R LOT: 220312A01A GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474571 ↗
• MalfunctionMar 3, 2022Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED INFORMATION THAT AN ECHELON MICROCATHETER WAS PERFORATED BY GUIDEWIRE FROM THE CATHETER TIP AT THE DISTAL END OF THE SHAFT. THE PATIENT WAS UNDERGOING RUPTURED ANEURYSM COIL EMBOLIZATION TREATMENT. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE MIDDLE CAROTID ARTERY (MCA). THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS OF THE PACKAGE INSERT. HE PACKAGED MANDREL WAS USED FOR THE STEAM SHAPING. SINCE GW PENETRATED FROM TIP OF THE CATHETER DURING INSERTION, IT WAS REMOVED FROM PATIENT BODY TO CHECK, AND THEN DISPOSED. TREATMENT WAS CONTINUED WITH A NEW PRODUCT, AND AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO RESISTANCE WHEN PASSING THE GUIDEWIRE/STYLET. THERE WAS NO DAMAGE TO THE GUIDEWIRE. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: CHIKAI14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664994 ↗
• InjuryNov 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS BEING TREATED FOR A 4 MM, SACCULAR ANEURYSM OF THE RIGHT ANTERIOR COMMUNICATING (ACOM) ARTERY. IT WAS UNKNOWN HOW THE PATIENT WAS RECOVERING FROM THE PROCEDURE, BUT THERE WERE NO SYMPTOMS IMMEDIATELY AFTER TREATMENT, AND NO ADVERSE EVENTS TO REPORT AT THAT THIS TIME. THE DISLODGED MARKER BAND WAS NOT FOUND, AND NO MORE ATTEMPTS WERE MADE TO LOCATE IT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10848661 ↗

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