EkoSonic® 6795-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00858593006301), received between Jul 14, 2017 and Sep 3, 2024 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2024Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21 AUG 2024. IT WAS REPORTED THAT THERE WAS INSUFFICIENT OUTPUT. A 135X40CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR A PERIACETABULAR OSTEOTOMY (PAO) RIGHT LEG AND SHEATH TO LEFT GROIN PROCEDURE. COOLANT WAS ADMINISTERED AT 35ML/HR AND DRUG WAS AT 1MG/HR. APPROXIMATELY 4 HOURS INTO THERAPY RUN TIME, THERE WAS A RED X MSD ALARM FOLLOWED BY AN EKOS WAVES AND RED X ALARM. THE NURSE CONFIRMED THAT THE MSD WAS PROPERLY SEATED. NO BENT PINS OR FLUID INGRESS WERE NOTED. TOGGLE SWITCH WAS TURNED OFF FOR 30 SECONDS, AND THE NURSE PRESSED START. THE ALARM RETURNED WITH BOX WITH RED X EKOS WAVES. ALL MSD GROUPS DISABLED. THE NURSE WENT THROUGH CHECKING MSD AGAIN. IT WAS DECIDED TO RUN THE CATHETER AS A PLAIN INFUSION CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE DRUG LUER WAS CRACKED AND LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129618 ↗
• MalfunctionOct 30, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EKOS DEVICE WAS LEAKING LYTIC. AN EKOSONIC ENDOVASCULAR DEVICE, 135X40CM WAS SELECTED FOR USE TO TREAT A CASE OF DEEP VEIN THROMBOSIS. THE TARGET LESION WAS ACCESSED VIA THE LEFT GROIN. AFTER OVER 17 HOURS OF EKOS THERAPY WITHOUT ISSUE, IT WAS OBSERVED THAT THERE WAS FLUID LEAKING FROM THE STRAIN RELIEF, PAST THE CATHETER MANIFOLD. AFTER THE COOLANT RATE WAS DROPPED, THE LEAK DID NOT SUBSIDE. IT WAS PRESUMED THAT THE LEAK WAS ATTRIBUTED TO LYTIC. THE PHYSICIAN ELECTED TO REMOVE THE EKOS DEVICE FROM THE PATIENT AT AROUND 9:30 AM, WHILE STILL IN THE ICU. THE TPA DRIP WAS CONNECTED DIRECTLY TO A 65CM SHEATH IN THE MID SUPERFICIAL FEMORAL ARTERY UNTIL THE PATIENT COULD BE TAKEN TO THE CATHETERIZATION LAB FOR THE SCHEDULED RECHECK. AT APPROXIMATELY 12PM, THE PATIENT WAS RETURNED TO THE CATHETERIZATION LAB. THERE WAS OBSERVED TO BE COMPLETE RESOLUTION OF THE CLOT. NO FURTHER TREATMENT WAS NEEDED, AND THE CASE WAS SUCCESSFULLY COMPLETED. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035351 ↗
• InjuryOct 25, 2023Break; Device Displays Incorrect Message; Break; Device Displays Incorrect Message

  IT WAS REPORTED THAT A BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 135X40CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CONSOLE KEPT GIVING AN ALARM. THE ULTRASONIC CORE WAS LEFT IN. DURING REMOVAL OF THE ULTRASONIC CORE, SOME OF THE DISTAL PORTION BROKE OFF. WHEN THE .035 WIRE WAS PUSHED THROUGH THE WIRE PORT, THE REMAINING PORTION OF THE UNLTRASONIC CORE WIRE WAS PUSHED OUT OF THE DISTAL END. ATTEMPTS MADE TO SNARE THE DEVICE OUT OF THE PATIENT WERE UNSUCCESSFUL. A POPLITEAL CUT DOWN WAS PERFORMED TO RETRIEVE THE FOREIGN BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18006826 ↗
• InjuryMay 31, 2023Break; Break

  IT WAS REPORTED THAT A FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. AN EKOSONIC ENDOVASCULAR DEVICE, 135X40CM WAS SELECTED FOR USE IN THE LEG. WHEN THE ULTRASONIC CORE (USC) WAS ADVANCING WITHIN THE INFUSION CATHETER (IC), RESISTANCE WAS NOTED. THE PHYSICIAN TOOK AN X-RAY AND SAW THAT THE USC HAD FRACTURED ENTIRELY WITHIN THE MICROCATHETER INSIDE OF THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PORTION OF THE USC USING A SNARE. THE ENTIRE EKOS DEVICE WAS REMOVED AND REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031887 ↗
• InjuryJun 1, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED. A 135 X 40CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR TREATMENT. A FEW MINUTES AFTER THE ULTRASOUND HAD BEEN ACTIVATED, AN ALARM WAS RECEIVED ON THE PT3B CONTROL UNIT INDICATING THE TEMPERATURE WAS TOO HIGH ON THE DEVICE. DURING TROUBLESHOOTING WITH THE EKOS HELPLINE, COOLANT FLOW WAS INCREASED UP TO 100ML/ HOUR BUT THE ERROR WAS NOT RESOLVED. THE CONTROL UNIT WAS TURNED OFF AND ON, THE CABLES WERE DISCONNECTED AND CHECKED FOR ANY MOISTURE BUT THE ALARM REMAINED UNRESOLVED. THE CATHETER WAS EVENTUALLY REPLACED AND WORKED WITHOUT ANY PROBLEMS. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566263 ↗
• MalfunctionMar 30, 2022Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE. A 135X40CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR A UNILATERAL PULMONARY ARTERY OCCLUSION PROCEDURE. DURING PLACEMENT OF THE EKOSONIC ENDOVASCULAR DEVICE, THE INFUSION CATHETER WOULD NOT TRACK CONTRALATERALLY OVER THE .035 INCH GUIDEWIRE. THE INFUSION CATHETER KEPT GETTING STUCK AND EVENTUALLY KINKED. THE DEVICE BECAME DIFFICULT TO REMOVE, AND AFTER A SHORT PERIOD OF TIME, THE WIRE AND CATHETER WERE ABLE TO BE REMOVED TOGETHER. THE WIRE AND CATHETER WERE ABLE TO BE SEPARATED AFTER REMOVAL FROM THE PATIENT; HOWEVER, A DIFFERENT WIRE AND A DIFFERENT EKOSONIC CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957347 ↗
• MalfunctionDec 13, 2019Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  ON (B)(6) 2019, EKOS DISTRIBUTOR REPORTED AN EVENT THAT ON THE THIRD DAY OF TREATMENT, TEMPERATURE TOO HIGH SIGN WAS NOTICED ON THE CONTROL UNIT (CU). THE CUSTOMER FLUSHED THE CATHETER PER HOSPITAL'S PROTOCOL BUT COULD NOT RESOLVE THE ALARM. THE SIGN WAS STILL SHOWING. NO OTHER INFORMATION WAS PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND INVESTIGATIONS ON 09 DECEMBER 2019 SHOWED A SHORT IN AN MICROSONIC DEVICE (MSD) ELEMENT THAT APPEARED TO CAUSE A BURN IN THE COOLANT SHAFT. THIS WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9469751 ↗
• InjuryApr 3, 2019Temperature Problem; Temperature Problem

  ON (B)(6) 2019, A PHYSICIAN CONTACTED EKOS INFORMING THAT HE PERFORMED A VENOUS CASE AND FOUND THE PATIENT TO BE IN EXCRUCIATING PAIN AFTER PLACEMENT OF EKOS CATHETER. THE PAIN WAS FROM THE ACCESS SITE IN THE POPLITEAL ALL THE WAY UP THE PATIENT LEG. HE REPORTED THAT THE PATIENT'S MOTOR FUNCTION IN THE LEG HAD GOTTEN WORSE WHILE THE CATHETER WAS IN THE PATIENT. THE PHYSICIAN DECIDED TO REMOVE THE CATHETER. HE TURNED THE US OFF AND REMOVED THE CATHETER AND FOUND IT TO BE EXTREMELY HOT BUT NOBODY SUSTAINED ANY BURNS. AFTER REMOVAL, THE PATIENT'S PAIN WENT FROM A "9" DOWN TO A "3". TREATMENT WAS DISCONTINUED AND NO FURTHER ACTION WAS NEEDED OR EXECUTED. THERE WERE NO PATIENT SEQUALA REPORTED.

  Patient problems: Pain

  MAUDE report 8478008 ↗
• MalfunctionMar 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERIAL OCCLUSION (PAO) CASE, THE DOCTOR USED A 40 CM TREATMENT LENGTH EKOS CATHETER AND A 7 (B)(6) INTRODUCER SHEATH. THE BIFURCATION WAS REPORTEDLY VERY TORTUOUS. THE PHYSICIAN PLACED THE 40 CM EKOS WITH A LOT OF DIFFICULTY. UPON COMPLETION OF THERAPY, THE PAO OCCLUSION WAS COMPLETELY CLEARED AND THE PATIENT WAS REPORTEDLY STABLE. THE PHYSICIAN REPORTED THE CORE WIRES WERE SHREDDED AFTER THE DEVICE WAS PULLED. THERE IS NO PATIENT SEQUELA REPORTED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441950 ↗
• MalfunctionAug 31, 2018Fracture; Electrical Shorting; Material Deformation; Fracture; Electrical Shorting; Material Deformation

  IT WAS REPORTED THAT A 40 CM EKOS CATHETER WAS USED TO TREAT A PATIENT WITH A PERIPHERAL ARTERIAL OCCLUSION ON (B)(6) 2018. THE CATHETER RAN FOR 7 HOURS AND 17 MINUTES WHEN AN 'ALL MSD FAILURE' ALARM OCCURRED. THE TREATMENT WAS CONTINUED WITHOUT ULTRASOUND AS A STANDARD CDT THERAPY WITHOUT ANY PATIENT IMPACT. UPON INVESTIGATION OF THE RETURNED DEVICE ON 06 AUG 2018, DEVICE DAMAGE WAS CONFIRMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837517 ↗
• MalfunctionOct 9, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A 135CM/40CM EKOSONIC CATHETER, S/N (B)(4), WAS USED TO TREAT A PATIENT ON (B)(6) 2017. THE PHYSICIAN SUCCESSFULLY PLACED THE INFUSION CATHETER (IDDC, PART OF THE EKOSONIC CATHETER) IN THE PATIENT AND SUBSEQUENTLY PLACED ULTRASOUND CORE (MSD, MICROSONIC DEVICE) INSIDE THE IDDC. IT WAS REPORTED TO EKOS THAT FLUID WAS LEAKING FROM THE CATHETER. THEY DESCRIBED THE MANIFOLD SECTION (WHERE THE MSD AND IV FLUIDS MEET) OF CATHETER AS THE SOURCE OF THE LEAK. THE NURSE NOTIFIED THE PHYSICIAN THE CATHETER WOULD NEED TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6930207 ↗
• MalfunctionJul 14, 2017Bent; Device Inoperable; Device Handling Problem; Bent; Device Inoperable; Device Handling Problem

  THIS IS A FOLLOW UP REPORT TO CORRECT THE ASSESSMENT MADE IN THE INITIAL REPORT. REFER TO INITIAL MDR 3001627457-2017-00023 FOR EVENT DESCRIPTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6714257 ↗