EchelonTM 190-5091-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00847536006294), received between Aug 29, 2018 and Sep 28, 2026 — classified as 1 death, 34 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K042187, K051990, 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924272 ↗
• MalfunctionMar 18, 2026Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE, THE MICROGUIDE WAS INSERTED, AND UPON REACHING THE DISTAL SEGMENT OF THE ECHELON 10 90° PRE-SHAPED TIP MICROCATHETER, THE GUIDE CAME OUT THROUGH THE SIDE. THE MICROCATHETER WAS REMOVED, AND ANOTHER ECHELON 10 90° WAS USED WITHOUT INCIDENT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, THE EVENT DID NOT LEADTO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL VESSEL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634049 ↗
• MalfunctionFeb 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT DISCHARGED. THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. THE AVIGO WAS STUCK INSIDE AND THERE IS A RESISTANCE FELT. THE GUIDEWIRE TIP WAS NOT SHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322691 ↗
• MalfunctionJan 23, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE PUNCTURE WITH THE GUIDEWIRE WAS THE WALL OF MICROCATHETER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216732 ↗
• MalfunctionOct 31, 2024Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577441 ↗
• DeathSep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT DEATH. THE PATIENT WAS UNDERGOING ANEURYSM TREATMENT, IMPLANTED SPRING COIL AND BLOOD FLOW DIVERSION DENSE MESH STENT. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNKNOWN ANEURYSM. ANEURYSM DIMENSIONS, BLOOD FLOW AND TORTUOSITY WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. IT WAS UNKNOWN IF DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS UNKNOWN. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DATE OF DEATH WAS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH WAS UNKNOWN. NO EQUIPMENT MALFUNCTION DURING THE OPERATION WAS IDENTIFIED. IT WAS UNKNOWN IF THE PATIENT FOLLOWED THE DOCTOR'S INSTRUCTIONS AND TAKE RELEVANT MEDICATIONS AFTER THE OPERATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN INTERNAL CAROTID ARTERY ANEURYSM NEAR THE INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY. THE CAUSE OF DEATH WAS UNKNOWN. THE FULL PROCEDURE, COMPLICATIONS DURING THE PROCEDURE AND WHEN THE PATIENT DIED WAS UNKNOWN. THE PO

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 20213600 ↗
• MalfunctionJul 12, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AN ECHELON MICROCATHETER TIP WAS BROKEN. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A SMALL ANEURYSM OF LEFT OPHTHALMIC ARTERY. THE VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (5.2 MM DIAMETER). AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE TIP OF THE MICROCATHETER WAS BROKEN AND COULD NOT BE USED NORMALLY. THERE WERE NO P ATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. ADDITIONAL INFORMATION RECEIVED THAT THERE WAS PREPARATION COMPLETED PRIOR TO NOTICE THE CATHETER DAMAGE; IT WAS FOUND DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731361 ↗
• MalfunctionJun 7, 2024Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE FOR HYDRATION, IT WAS FOUND THAT THE PROXIMAL END OF THE MICROCATHETER WAS LEAKING WATER. REPLACING THE PRODUCT TO COMPLETE THE SURGERY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 7MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483368 ↗
• MalfunctionFeb 29, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER WAS FOUND TO HAVE A LEAK AT THE HUB. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 3 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE PREOPERATIVE PREPARATION, THE MICROCATHETER WAS OPENED. WHEN FLUSHING, WATER LEAKAGE WAS FOUND AT THE CONNECTION BETWEEN THE HUB AT THE PROXIMAL END OF THE CATHETER AND THE MICROCATHETER, MAKING IT UNUSABLE. THIS PROBLEM WAS ELIMINATED WHEN REPLACING WITH ANOTHER MICROCATHETER, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. 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. ADDITIONAL INFORMATION RECEIVED THAT LARGE ANEURYSM IN THE C4. THE CATHETER LEAK WAS NOT MAN-MADE BUT THE CAUSE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812515 ↗
• MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD A LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM. AFTER THE CATHETER LEAK WAS NOTICED, IT WAS REMOVED IMMEDIATELY. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797059 ↗
• MalfunctionFeb 26, 2024Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON CATHETER'S TIP RUPTURED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION. THE ACCESSED VESSEL WAS THE RADIAL ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE ECHELON CATHETER TIP END MARKER POINT WAS BROKEN. IT WAS REPORTED THE CATHETER RUPTURED (INTACT). THE RUPTURED LOCATION WAS THE DISTAL SECTION. ASIDE FROM THE RUPTURE, THERE WAS NO OTHER DAMAGE TO THE CATHETER. THE INJECTION RATE WAS NORMAL SPEED. 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. ANCILLARY DEVICES INCLUDE A 6F NAVIEN GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18783312 ↗
• MalfunctionJan 5, 2024Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED A REPORT THAT THE PACKAGE WAS OPENED AND THE DEVICE WAS RINSED WITH HEPARIN. IT WAS NOTED THAT WHEN THE MICROCATHETER WAS SHAPED AND THE ACCESS WAS ESTABLISHED, THE GUIDEWIRE PASSED OUT FROM THE SIDE CLOSE TO THE TIP END OF THE MICROCATHETER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER 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 COIL EMBOLIZATION SURGERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 8MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455341 ↗
• MalfunctionAug 14, 2023Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN ECHELON 10 CATHETER TIP HAD A STITCH ON IT. WHILE PREPARATION OF THE CATHETER (FLUSHING THE CATHETER), THERE WAS A LITTLE STITCH COMING OUT OF THE CATHETER. THE CATHETER WAS FLUSHED AS PER INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS PER IFU. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17542094 ↗
• MalfunctionJul 17, 2023Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER PUNCTURE WAS OBSERVED ON THE PREPARATION BENCH PRE-OPERATIVELY. IT WAS NOTED THAT THE DEVICE DID NOT ENTER THE PATIENT. THE PROCEDURE WAS COMPLETED BY REPLACING THE ECHELON 10 WITH ANOTHER ECHELON 10 AND COMPLETED PROCEDURE WITH NO ADVERSE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332902 ↗
• MalfunctionJun 2, 2023Incomplete or Missing Packaging; Device Dislodged or Dislocated; Incomplete or Missing Packaging; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ANOTHER ECHELON WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052161 ↗
• MalfunctionMay 5, 2023Loss of or Failure to Bond; Patient-Device Incompatibility; Physical Resistance/Sticking; Loss of or Failure to Bond; Patient-Device Incompatibility; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE HYDROPHILIC COATING ON AN ECHLON CATHETER WAS DAMAGED IN THE PROXIMAL SECTION. THE CATHETER WAS DIFFICULT TO PUSH FORWARD. THERE WAS RESISTANCE IN THE PROXIMAL SECTION. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE PATIENT WAS UNDERGOING COILING TREATMENT. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA) WITH A DIAMETER OF 3MM. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE HYDORPHLIC COATING WAS DAMAGED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876540 ↗
• MalfunctionMar 17, 2023Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE CATHETER WAS DAMAGED.  THE PATIENT WAS UNDERGOING ANEURYSM EMBOLIZATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH 5.5MM DIAMETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE OPERATOR PERFORMED ANEURYSM TREATMENT AND NEEDED A MICROCATHETER OF MODEL 190-5091-150. AFTER THE PRODUCT WAS TAKEN OUT OF THE PACKAGE, THE TIP WAS FOUND TO BE BROKEN. THE OPERATOR THOUGHT IT WAS A PRODUCT QUALITY PROBLEM AND ASKED TO RETURN IT FOR IDENTIFICATION. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT PART OF THE CATHETER FRACTURED AND SEPARATED FROM THE REST. THE CATHETER WAS NOT KINKED/CRUSHED ETC., AFTER TAKING THE CATHETER OUT OF THE PACKAGING, THE TIP BROKE OFF AND FELL TO THE GROUND. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING; THE DEVICE WAS PACKAGED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565811 ↗
• MalfunctionFeb 27, 2023Break; Packaging Problem; Break; Packaging Problem

  NEW INFORMATION RECEIVED. THE CATHETER RUPTURED DURING HYDRATION AND FLUSHING. THE CATHETER WAS TAKEN OUT OF THE PACKAGE AND HYDRATED. IT WAS NOT EXPECT IT TO BE DAMAGED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443069 ↗
• MalfunctionNov 29, 2022Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A ECHELON CATHETER HAD RESISTANCE AND A REMOVAL OF THE COATING. IT WAS DIFFICULT TO PUSH THE ECHELON FORWARD, WHEN YOU FEEL OUTSIDE OF THE PATIENT THE CATHETER SURFACE YOU FEEL NO LONGER THE HYDROPHILIC COATING. WITH A NEW ECHELON THERE WAS NO PROBLEMS. THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. THE DEVICES WERE PREPARE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING ANEURYSM COILING. VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA) WITH A DIAMETER OF 3MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882429 ↗
• MalfunctionNov 21, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE KINKED MARKSMAN WAS UNCERTAIN. THE STENT COULD NOT BE PUSHED OUT IN THE BODY, AND THE STENT WAS WITHDRAWN OUTSIDE THE BODY AND IT WAS FOUND TO BE KINKED. IT WAS POSSIBLE THAT THE PATH WAS TORTUOUS AND THE RESISTANCE WAS TOO LARGE. THE RESISTANCE WAS IN THE DISTAL SOFT SEGMENT OF THE MARKSMAN, AND THE PIPELINE PUSHWIRE WAS NOT DAMAGED. THE ECHELON HAD DISCONNECTED SUDDENLY, AND THE REASON FOR THIS WAS NOT FOUND AFTER POSTOPERATIVE REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839571 ↗
• MalfunctionMay 18, 2022Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT WHEN THE ECHELON 10 CATHETER PACKAGE WAS OPEN THE CATHETER WAS FOUND TO HAVE A KINK AT THE DISTAL END. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NOT ANY DAMAGE TO THE DEVICE PACKAGING IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431207 ↗
• MalfunctionApr 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN COULDN'T VISUALIZE THE RADIOPAQUE TIP OF THE ECHELON 10 MICROCATHETER AS IT DID NOT HAVE A MARKER. THE CATHETER WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION OR HOSPITALIZATION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162493 ↗
• MalfunctionFeb 7, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT WHEN OPENING, DISTAL PART OF ECHELON MICROCATHETER HAD BEEN TORN BY USER. THERE IS NO PATIENT OR PHYSICIAN INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476650 ↗
• MalfunctionJan 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ECHELON MICROCATHETER TIP MARKER THAT WAS NOT VISIBLE DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING AN INTRACRANIAL ANEURYSM EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE ECHELON CATHETER WAS PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). WHEN THE ECHELON CATHETER WAS DELIVERED, THE DEVELOPING POINT AT THE TIP END WAS NOT OBVIOUS. WHEN ENTERING THE ANEURYSM, THE TIP POSITION COULD NOT BE DETERMINED. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13334147 ↗
• MalfunctionSep 29, 2021Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ECHELON CATHETER THAT HAD WIRE DRAWING DAMAGE. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE GUIDE CATHETER WAS IN PLACE. THE ECHELON-10 MICROCATHETER WAS OPENED AND WAS FOUND TO HAVE WIRE DRAWING DAMAGE AT THE DISTAL TIP. THE CATHETER WAS REPLACED AND THE REPLACEMENT CATHETER WAS USED TO SUCCESSFULLY PLACE 3 COILS TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DAMAGE WAS NOTICED AS SOON AS THE PACKAGE WAS OPENED. AFTER THE SURGEON OPENED THE PACKAGE AND FOUND THE PROBLEM, THEY DID NOT USED IT AND REPLACED IT WITH A NEW MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042187, K051990, 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