EkoSonic® 6795-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00858593006264), received between Jan 19, 2017 and May 22, 2024 — classified as 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 25, 2022Open, Classified

   Product may be mislabeled.

   Z-1491-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT AN ERROR CODE WAS OBSERVED, RESULTING IN THE REPLACEMENT OF THE CATHETER. THIS 135X12CM EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE IN A BILATERAL PERIPHERAL ARTERIAL OBSTRUCTION PROCEDURE. AN E311 ERROR OCCURRED ON CHANNEL B DURING TREATMENT IN THE INTENSIVE CARE UNIT. THE PATIENT WAS BROUGHT BACK TO THE CATHETERIZATION LABORATORY TO REPLACE BOTH IMPLANTED CATHETERS. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377213 ↗
• InjuryMay 22, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE LEAKING, REQUIRING INTERVENTION. THIS EKOSONIC ENDOVASCULAR DEVICE, 135X12CM WAS SELECTED FOR USE IN A BILATERAL PULMONARY EMBOLISM PROCEDURE. AFTER THE CATHETERS WERE PLACED, APPROXIMATELY ONE HOUR INTO TREATMENT, THE LUERS WERE NOTED TO BE LEAKING. THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LABORATORY TO REPLACE THE CATHETERS. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT WHEN THE LEAKING WAS OBSERVED, AN ATTEMPT WAS MADE TO TIGHTEN THE LUERS; HOWEVER, IT WAS THEN OBSERVED THAT THERE WERE HOLES AT THE LUERS. ONE CATHETER LEAKED FROM THE DRUG AND COOLANT LUER, AND ONE LEAKED FROM THE DRUG LUER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372905 ↗
• InjuryMay 22, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE LEAKING, REQUIRING INTERVENTION. THIS EKOSONIC ENDOVASCULAR DEVICE, 135X12CM WAS SELECTED FOR USE IN A BILATERAL PULMONARY EMBOLISM PROCEDURE. AFTER THE CATHETERS WERE PLACED, APPROXIMATELY ONE HOUR INTO TREATMENT, THE LUERS WERE NOTED TO BE LEAKING. THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LABORATORY TO REPLACE THE CATHETERS. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT WHEN THE LEAKING WAS OBSERVED, AN ATTEMPT WAS MADE TO TIGHTEN THE LUERS; HOWEVER, IT WAS THEN OBSERVED THAT THERE WERE HOLES AT THE LUERS. ONE CATHETER LEAKED FROM THE DRUG AND COOLANT LUER, AND ONE LEAKED FROM THE DRUG LUER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372903 ↗
• InjuryFeb 22, 2024Leak/Splash; Leak/Splash

  PEERLESS STUDY. IT WAS REPORTED THAT THE EKOS DEVICE WAS LEAKING FROM BOTH THE DRUG AND COOLANT LINES, AND THE PATIENT WAS RETURNED TO THE CATHETERIZATION LAB FOR DEVICE EXCHANGE. AN EKOSONIC ENDOVASCULAR DEVICE, 135X12CM WAS SELECTED FOR USE IN THE RIGHT PULMONARY ARTERY. UPON TRANSFER TO THE CRITICAL CARE UNIT (CCU), IT WAS OBSERVED THAT THE INFUSION CATHETER IN THE RIGHT PULMONARY ARTERY WAS LEAKING FROM BOTH THE DRUG AND COOLANT LINES. THE SUBJECT WAS RETURNED TO THE CATHETERIZATION LAB AND THE EKOS DEVICE WAS EXCHANGED TO RESOLVE THE ISSUE. THERE WERE NO FURTHER PATIENT OR PROCEDURE DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763723 ↗
• InjuryMay 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  REPORTABLE BASED ON FURTHER INFORMATION RECEIVED ON 02MAY2023 AND DEVICE ANALYSIS. IT WAS REPORTED THAT THE INFUSION CATHETER (IC) WAS NOT WORKING. AN EKOSONIC ENDOVASCULAR DEVICE, 135X12CM WAS SELECTED FOR USE. THE TARGET LESION WAS LOCATED WITHIN THE RIGHT PULMONARY ARTERY. WHEN THE EKOSONIC DEVICE WAS CONNECTED TO THE CONTROL UNIT (CU), THERE WAS AN ERROR MESSAGE THAT INDICATED THE IC WAS NOT CONNECTED. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. THE EKOSONIC ENDOVASCULAR DEVICE WAS REPLACED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE MALFUNCTION, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS MISSING BOTH MARKER BANDS FROM THE IC, AND THE ROUNDED TIP FROM THE ULTRASONIC CORE (USC). THE CUSTOMER WAS ABLE TO CONFIRM THAT THE MARKER BANDS WERE PRESENT ON THE DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. THE CUSTOMER WAS UNABLE TO CONFIRM WHETHER THE USC TIP MAY HAVE DETACHED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009966 ↗
• MalfunctionFeb 3, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE PACKAGING SEAL WAS BROKEN, AND STERILITY WAS COMPROMISED. AN EKOSONIC ENDOVASCULAR DEVICE, 135X12CM WAS SELECTED FOR THE PULMONARY EMBOLISM PROCEDURE. DURING DEVICE PREPARATION, IT WAS DISCOVERED THAT THE OUTER BOX WAS DAMAGED, AS THOUGH THE CORNER HAD BEEN CRUSHED. ADDITIONALLY, THE SEAL OF THE DEVICE PACKAGING WAS TORN. THE DEVICE STERILITY WAS QUESTIONED, AND THE DEVICE WAS DISCARDED. THE PROCEDURE WAS COMPLETED USING A NON-BSC MECHANICAL THROMBECTOMY DEVICE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294354 ↗
• InjuryMar 10, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THROMBUS OCCURRED. AN EKOSONIC CATHETER WAS SELECTED FOR USE TO TREAT A THROMBUS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE UNDERLYING MEDICAL CONDITION OF THE PATIENT WAS ACUTE THROMBUS. HEPARIN WAS GIVEN AT 12MG/HR AND LYTIC AT 1 MG/HR OVER THE COURSE OF 24 HOURS. DURING TREATMENT OF THE THROMBUS WITH THE EKOSONIC CATHETER, THE CLOT WAS NOT CLEARED UP, AND IT INCREASED IN SEVERITY WHILE THE CATHETER WAS IN PLACE. THE PHYSICIAN OBSERVED THAT THE PULSE WAS LOST IN THE FOOT. THE INCREASE IN THROMBUS WAS ATTRIBUTED TO A CATHETER MALFUNCTION BY THE PHYSICIAN. THE PROCEDURE WAS THEN COMPLETED THE FOLLOWING DAY WITH A CDT CATHETER. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13727002 ↗
• InjuryOct 19, 2021Device Alarm System; Obstruction of Flow; Defective Device; Device Alarm System; Obstruction of Flow; Defective Device

  IT WAS REPORTED THAT A DRUG OCCLUSION OCCURRED RESULTING IN CATHETER REPLACEMENT. AN EKOSONIC ENDOVASCULAR DEVICE WAS SELECTED FOR USE DURING A BILATERAL PULMONARY EMBOLISM THROMBOLYSIS PROCEDURE. AFTER CATHETER PLACEMENT, THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU). SHORTLY AFTER ARRIVAL TO THE ICU, THE HOSPITAL SUPPLIED INFUSION PUMP ALARMED WITH A DOWNSTREAM OCCLUSION TO THE DRUG LINE ON BOTH INFUSION PUMPS. STOPCOCKS AND ROLLER CLAMPS WERE REPORTED TO BE OPEN. NO CATHETER KINKS WERE NOTED. THE USER FLUSHED THE LINE WITH A 10C AND A 3CC SYRINGE FOR NO RESOLUTION. THE DRUG INFUSION PUMP WAS ALSO REPLACED AND THE ALARM CONTINUED. ALL TROUBLESHOOTING STEPS WERE EXHAUSTED. THE PHYSICIAN DECIDED TO BRING THE PATIENT BACK TO THE CATHETERIZATION LAB FOR CATHETER REPLACEMENT. NO FURTHER ISSUES WERE REPORTED. NO PATIENT CONSEQUENCES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12660517 ↗
• MalfunctionAug 13, 2021Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  IT WAS REPORTED A DRUG OCCLUSION OCCURRED AND REQUIRED AN ADDITIONAL PROCEDURE. TWO EKOSONIC KIT 106CM 12CM TZ CATHETERS WERE PLACED IN THE GROIN THROUGH AN UNSPECIFIED 6F SHEATH FOR THE TREATMENT OF A BILATERAL PULMONARY EMBOLISM CASE. AFTER SEVEN HOURS OF THERAPY, THE COOLANT PUMP WAS ALARMING ON ONE OF THE CATHETERS. TROUBLESHOOTING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. WHILE TRYING TO FIX THE COOLANT OCCLUSION ISSUE, THE CATHETER IN THE OTHER PULMONARY ARTERY STARTED ALARMING ON THE DRUG PORT. AGAIN TROUBLESHOOTING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE CATHETERS WERE REMOVED AND THE PATIENT STILL HAD RESIDUAL CLOT SO A SECOND EKOS THERAPY PROCEDURE HAD TO BE PERFORMED THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318748 ↗
• MalfunctionJul 22, 2021Electrical /Electronic Property Problem; Leak/Splash; Electrical /Electronic Property Problem; Leak/Splash

  IT WAS REPORTED THAT A LEAK OCCURRED AND AN ERROR MESSAGE DISPLAYED. AN EKOSONIC CATHETER WAS SELECTED FOR USE IN A UNILATERAL PULMONARY EMBOLISM PROCEDURE. DURING THE PROCEDURE, A SIGNIFICANT FLUID LEAK OCCURRED AT THE HUB OF THE DEVICE. ADDITIONALLY, THE CONTROL UNIT DISPLAYED AN E322 ALARM INDICATING ALL THERMOCOUPLES INVALID. AT THIS TIME, TREATMENT HAD BEEN RUNNING OVER 29 HOURS. THE PHYSICIAN TURNED OFF THE COOLANT TO SEE IF THE FLUID LEAK WAS SALINE OR THROMBOLYTIC (TPA). THE LEAK WAS CONFIRMED TO BE TPA AS THE LEAK CONTINUED AFTER THE SALINE COOLANT WAS TURNED OFF. THE PHYSICIAN STATED THE CATHETER WOULD BE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12212088 ↗
• MalfunctionDec 11, 2018Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A PATIENT WITH A RIGHT UPPER ARM EXTREMITY DVT WAS TREATED WITH EKOS ON (B)(6) 2018. DURING THERAPY, ALARM CODE 'ALL MSD FAILURE' OCCURRED. EKOS WAS DISCONTINUED AND TREATMENT WAS CONTINUED AS STANDARD CDT (CATHETER DIRECTED THROMBOLYSIS). THE PATIENT WAS REPORTED AS BEING NONCOMPLIANT WITH THE INSTRUCTIONS/ADVICE OF THE STAFF AND PHYSICIAN. THE PATIENT WAS GETTING UP, WALKING AROUND THE ROOM, SITTING UP BEDSIDE AND "THRASHING ARM ABOUT" DURING THERAPY. THE PATIENT DID RECEIVE THE FULL DOSE OF THERAPY AND IS DOING VERY WELL. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153567 ↗
• MalfunctionJul 24, 2017Bent; Fracture; Device Handling Problem; Bent; Fracture; Device Handling Problem

  A 135 CM/12 CM EKOSONIC CATHETER WAS USED TO TREAT A PATIENT WITH A PULMONARY EMBOLI ON (B)(6) 2017. THE INFUSION CATHETER (PART OF THE EKOSONIC CATHETER) AND ULTRASOUND CORE WIRE (MICROSONIC DEVICE, MSD) WERE INITIALLY PLACED SUCCESSFULLY IN THE PATIENT. AFTER 1 HOUR AND 45 MINUTES OF THERAPY, THE CONTROL UNIT HAD A TEMPERATURE ALARM. THE EVENT LOG OF THE ORIGINAL CONTROL UNIT SHOWED ARTIFICIAL TEMPERATURE READINGS AND IT WAS REQUESTED TO HAVE THE ARTIFICIAL CATHETER SET RETURNED. THE CATHETER SET WAS EVALUATED ON (B)(6) 2017. IT WAS FOUND THAT THE MSD WAS DAMAGED AND TWISTED 4 CM-15.5 CM FROM THE PROXIMAL END OF THE STRAIN RELIEF AND THE DAMAGE BROKE THROUGH THE PROTECTIVE TUBING AND EXPOSED SOME RF WIRES. FRACTURED MATERIAL FROM THE MSD POLYIMIDE/STAINLESS STEEL BRAIDED SHEATH TUBING WAS FOUND IN THE IDDC COOLANT LUMEN. UPDATE FROM THE SALES REPRESENTATIVE ON 7/3/2017 STATED THE PATIENT RECEIVED A FULL DOSE OF THROMBOLYTICS AND IS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6736683 ↗
• MalfunctionJan 19, 2017Detachment Of Device Component; Device Dislodged or Dislocated; Detachment Of Device Component; Device Dislodged or Dislocated

  PHYSICIAN CALLED COMPANY REPRESENTATIVE ON (B)(6) 2016 TO LET HIM KNOW "HE HAD AN ISSUE WHEN REMOVING THE CATHETER FROM THE SHEATH. THE EKOS CATHETER GOT CAUGHT WITHIN THE SHEATH AND THE DISTAL MARKER SHEARED OFF. FORTUNATELY, THE MARKER STAYED WITHIN THE SHEATH AND THE PHYSICIAN WAS ABLE TO RETRIEVE IT." THE PHYSICIAN PERFORMED A FOLLOW-UP X-RAY TO ENSURE THERE WASN'T ANY OTHER PIECES LEFT AFTER THE REMOVAL. THE PATIENT IS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6265474 ↗