FountainRecalls & reported problems across all models

We found 7 models of Fountain by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Sep 25, 2020 and Sep 24, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Fountain recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 6, 2023Open, Classified

   The sterility of microcatheter and infusion system devices cannot be guaranteed.

   Z-0629-2024 · Root cause: Package design/selection · names 2 of these models · Recall details · FDA record ↗

Most reported Fountain problems

Fountain models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fountain® 00884450000885

  Catheter, continuous flush
  1 recall0 reports
• Fountain® 00884450006504

  Catheter, continuous flush
  1 recall0 reports
• Fountain® 00884450011676

  Catheter, continuous flush
  2 reports
• Fountain® 00884450012277

  Catheter, continuous flush
  1 report
• Fountain® 00884450023457

  Catheter, continuous flush
  1 report
• Fountain® 00884450025482

  Catheter, continuous flush
  1 report
• Fountain® Initial Release

  Catheter, continuous flush
  1 report

Recent Fountain adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Unsealed Device Packaging; Unsealed Device Packaging

  THE ACCOUNT ALLEGES THAT THE SEAL OF THE INNER PACKAGING OF THE DEVICE WAS NOT APPROPRIATELY SEALED; A BREACH IN THE PACKAGING RESULTS IN INCOMPLETE STERILIZATION OF THE CONTENTS. NO PATIENT INTERACTION OR INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294749 ↗
• MalfunctionAug 31, 2022Fracture; Material Separation; Material Twisted/Bent; Fracture; Material Separation; Material Twisted/Bent

  THE ACCOUNT ALLEGES THAT DURING AN ELECTIVE PROCEDURE FOR PERIPHERAL ARTERIAL OCCLUSION BETWEEN RIGHT FEMORAL AND POPLITEAL ARTERIES THE WIRE BROKE WHILE REMOVING. ALTHOUGH THE VESSELS HAD CALCIFICATION, NO SIGNIFICANT TORTUOSITY HAS NOT BEEN FOUND. CONTRALATERAL APPROACH FROM LEFT FEMORAL ARTERY WAS USED FOR THE PROCEDURE. AFTER THE COMPLETION OF THE INFUSION WITH THE INFLUSION CATHETER, THE OCCLUDING WIRE WAS ATTEMPTED TO BE WITHDRAWN, LEAVING THE INFUSION CATHETER IN THE VESSEL. AT THIS TIME, THE OPERATOR FELT PHYSICAL RESISTANCE AT THE VICINITY OF A Y-CONNECTOR AT THE OPERATOR'S [PROXIMAL] END OF THE PRODUCT. HOWEVER, THE OPERATOR PULLED THE WIRE OUT, AND THE WIRE GOT BROKEN OFF. THE BREAKAGE SITE WAS MORE PROXIMAL TO THE BALL AT THE TIP OF THE WIRE. THE ENTIRE PORTION OF THE WIRE WAS WITHDRAWN OUT WITH THEINFUSION CATHETER, DEEMING THAT THE BALL WITH THE BROKEN PORTION OF THE WIRE WOULD NOT TRANSFER INTO PATIENT'S BODY FROM THE CATHETER TIP. AFTER THE WITHDRAWAL, IT WAS FOUND THAT THE CATHETER HAD KINKED. THE KINK WAS NOT FOUND BEFORE USE. THE PLANNED PROCEDURE WAS COMPLETED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331357 ↗
• InjuryJun 29, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES WHILE PLACING AN INFUSION CATHETER WITHIN THE FEMORAL VEIN OF A PATIENT DIAGNOSED WITH DEEP VENOUS THROMBOSIS [DVT] THE CATHETER KINKED AND DETACHED WITHIN THE FEMORAL VEIN. THE CLINICIAN PERFORMED A CUTDOWN PROCEDURE TO SUCCESSFULLY REMOVE THE FOREIGN BODY FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861638 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT AFTER PLACING ANTICOAGULATION IN A LEFT ILIAC VENOUS INDWELLING CATHETER TO MAINTAIN VASCULAR ACCESS, THE PATIENT DEVELOPED A HIGH FEVER. BLOOD CULTURE CAME BACK POSITIVE DUE TO LONG TERM USE OF THE DEVICE. THE CATHETER WAS REMOVED AND ANTIBIOTICS ADMINISTERED.

  Patient problems: Unspecified Infection

  MAUDE report 12700111 ↗
• InjuryMay 6, 2021Fracture; Fracture

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL THROMBOLYTIC PROCEDURE ON A PATIENT DIAGNOSED WITH PERIPHERAL VASCULAR DISEASE [PVD], THE THROMBOLYTIC CATHETER TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED ARTERIAL ACCESS AND HAD SUCCESSFULLY NEGOTIATED THE PATIENTS CHALLENGING AND DISEASED VASCULATURE UNDER FLUOROSCOPY. THE THROMBOLYTIC CATHETER WAS SUCCESSFULLY PLACED WITHIN THE PATIENT'S SUPERFICIAL FEM-POP ARTERY IN AN ATTEMPT TO RESTORE PATIENT'S BLOOD FLOW TO THE LOWER PERIPHERY. DURING REMOVAL OF THE THROMBOLYTIC CATHETER FOR FOLLOW-UP IMAGING, THE TIP DETACHED WITHIN THE PATENT'S LOWER EXTREMITY. THE ACCOUNT STATES THAT AN ATTEMPT TO RETRIEVE THE FOREIGN BODY IN TOTAL, MAY NOT HAVE BEEN COMPLETELY SUCCESSFUL. POST PERIPHERAL VASCULAR INTERVENTION, THE PATIENT UNDERWENT A LOWER EXTREMITY (LE) AMPUTATION BECAUSE OF THE UNSUCCESSFUL THROMBOLYTIC THERAPY ATTEMPTS. THE ACCOUNT STATES THAT THE AMPUTATION WAS NECESSARY DUE TO THE CURRENT DISEASE STATE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787791 ↗
• InjurySep 25, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A SLOW-CONTINUOUS VASCULAR INFUSION PROCEDURE, THE OCCLUSION WIRE PLACED WITHIN THE CATHETER TO ACTIVATE THE UNIFORM DISPERSION OF THERAPEUTIC AGENTS WITHIN THE PATIENT DETACHED WITHIN THE VASCULAR SYSTEM. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FOREIGN BODY FROM THE PATIENT WITH A VASCULAR SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10587510 ↗

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