SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) 0684-00-0576-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,541 adverse event reports that list this exact device (DI 10607567108605), received between Sep 17, 2019 and Sep 17, 2026 — classified as 33 deaths, 33 injuries, 1,475 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (477 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 23, 2023Class IIOpen, Classified

   During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

   Z-2222-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2022Class IIOpen, Classified

   Certain lots containing undersized dilator.

   Z-1686-2022 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,541 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Leak/Splash

  It was reported by the customer that Gas Loss alarm occured on a CARDIOSAVE Intra-Aortic Balloon Pump (IABP) during support with a Sensation Plus 50cc Intra-Aortic Balloon (IAB) catheter for left ventricular (LV) assist following surgery. Approximately six hours after insertion, while the patient was in the intensive care unit (ICU), a Gas Loss alarm occurred. No blood was observed in the helium tubing. IABP therapy was discontinued and the IAB catheter was removed. No patient harm or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800364 ↗
• MalfunctionSep 1, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538970 ↗
• InjuryAug 30, 2026Fluid/Blood Leak; Difficult to Remove; Material Rupture

  Patient problems: Insufficient Information

  MAUDE report 50514637 ↗
• MalfunctionAug 27, 2026Leak/Splash

  It was reported that during use of the Sensation Plus 50cc balloon catheter, the CARDIOSAVE pump generated a Gas Loss alarm, causing the Intra-Aortic Balloon Pump (IABP) therapy to stop. Intra-Aortic Balloon (IAB) fill was done by pressing IAB refill and therapy was restarted; however, the issue recurred. The IAB catheter was inspected, and no signs of perforation were observed. No blood was detected in the helium line. The helium tank was confirmed to be adequately filled and not empty. All system connections were checked and found to be secure. The patient was not tachycardic or febrile at the time of the event. No harm to the patient reported. The alarm occurred during the night before and morning of the (b)(6). The balloon pump was exchanged for a new machine on the night shift. Second pump also generated a Gas Loss alarm. The details of the first pump are not available. A Getinge Filed Service Engineer (FSE) was dispatched to evaluate the IABP used as a second unit. FSE confirmed gas loss alarms in logs. No other errors or leak were noted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472651 ↗
• MalfunctionAug 7, 2026Leak/Splash; Material Deformation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50171487 ↗
• MalfunctionMay 18, 2026Device Sensing Problem

  (B)(6), CVICU RN, CALLED INTO THE EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT WITH A FIBEROPTIC SENSOR FAILURE ON A CARDIOSAVE. SHE WAS UNABLE TO OBTAIN AN A/P WAVEFORM AND SWITCHED TO TRANSDUCING THE INNER LUMEN. ESP PERSONNEL INSTRUCTED HER TO COIL AND LABEL THE FIBEROPTIC CABLE DO NOT USE. PUMP BP WAS 59/50 WITH AN UNABLE TO UPDATE TIMING ALARM ACTIVE. TROUBLESHOOTING IDENTIFIED EXCESS PRESSURE TUBING, WHICH WAS REMOVED. (B)(6) ASPIRATED AND FLUSHED THE LUMEN, AND PROPER SETUP WAS REINFORCED. THE WAVEFORM IMPROVED AND THE ALARM RESOLVED, THOUGH PULSE PRESSURE REMAINED NARROW (MAP 64). COMPARISON SHOWED RADIAL A/P 75/61 AND PUMP A/P 66/58. IMAGE REVIEW INDICATED ELEVATED HEART RATE, NARROW PULSE PRESSURE, AND AUGMENTATION 10 ABOVE SYSTOLIC BP. X RAY SHOWED THE MARKER BELOW THE 2ND AND 3RD INTERCOSTAL SPACE. ESP PERSONNEL ADVISED PROVIDER CONSULTATION FOR CLINICAL MANAGEMENT AND BALLOON PLACEMENT EVALUATION. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25197237 ↗
• MalfunctionApr 30, 2026Obstruction of Flow

  (B)(6) RN CALLS FROM THE ICU STATING THEY JUST RECEIVED A PATIENT TRANSFERRED FROM AN OUTLYING HOSPITAL TO (B)(6). HE STARTS TO (B)(6) RN CALLED INTO THE EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT FROM THE ICU, STATING THEY HAD JUST RECEIVED A PATIENT TRANSFERRED FROM AN OUTLYING HOSPITAL TO (B)(6). HE BEGAN TO DESCRIBE THAT THEY HAD TRANSFERRED THE THERAPY TO THEIR ARROW IABP AT (B)(6) WHEN (B)(6) RN FROM TRANSPORT JOINED THE CALL. (B)(6) STATED HE WANTED TO VERIFY WHAT TELEFLEX HAD ALREADY COMMUNICATED REGARDING A CLOTTED INNER LUMEN OF THE SENSATION PLUS 8FR 50CC IAB. HE WANTED TO CONFIRM THAT THE CATHETER DID NOT NEED TO BE REMOVED DUE TO THE CLOTTED INNER LUMEN. ESP PERSONNEL VERIFIED THAT INFORMATION AS ACCURATE AND REVIEWED MANAGEMENT OF THE CLOTTED INNER LUMEN WITH HIM. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044263 ↗
• MalfunctionApr 24, 2026Leak/Splash

  DURING USE, INTRA-AORTIC BALLOON (IAB) CATHETER INSERTED INTO PATIENT, THERE WAS BLOOD OBSERVED IN THE HELIUM LINE. BALLOON WAS EXPLANTED, NEW BALLOON INSERTED AND WAS OPERATIONAL. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980012 ↗
• MalfunctionApr 23, 2026Material Perforation; Device Contamination with Body Fluid; Gas/Air Leak

  THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER (REGISTERED NURSE) TO THE EMERGENCY SUPPORT PROGRAM. IT WAS REPORTED BY THE THAT WHILE USING SENSATION PLUS 50CC INTRA AORTIC BALLOON (IAB) THE REPORTER CALLED IN WITH A BALLOON PERFORATION. THE REPORTER STATED THE ONLY ALARM THEY HAD WITH THE PERFORATION WAS GAS LOSS AND THE BLOOD DID REACH THE CONSOLE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24962002 ↗
• MalfunctionApr 20, 2026Leak/Splash; Gas/Air Leak

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930981 ↗
• MalfunctionApr 16, 2026Device Sensing Problem

  (B)(6) RN CCU CALLED FOR ASSISTANCE WITH A FIBER OPTIC SENSOR FAILURE ALARM ON A CARDIOSAVE DURING USE. (B)(6) DENIED ANY KINK OR FOLD IN THE FO CABLE AND STATED THAT SHE HAD ALREADY UNPLUGGED AND RE PLUGGED THE FO SENSOR CABLE ONCE BEFORE. ESP PERSONNEL ASKED HER TO REPEAT THE STEP VERIFYING THAT IT WAS ARROW TO ARROW AND SEATED APPROPRIATELY. ESP PERSONNEL THEN REVIEWED THE STEPS TO TRANSITION FROM FO TO TRANSDUCER AS THE PRESSURE SOURCE AND REQUESTED SHE COIL TAPE AND LABEL THE FO CABLE AS FIBER OPTIC SENSOR FAILURE DO NOT USE. COMPLAINT INFORMATION OBTAINED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902767 ↗
• MalfunctionApr 16, 2026Failure to Sense; Device Sensing Problem

  IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT SENSATION PLUS 50CC HAD FIBER OPTIC (FO) SENSOR FAILURE ALARM DURING USE. NURSE DENIED ANY KINK OR FOLD IN THE FO CABLE AND STATED THAT SHE HAD ALREADY UNPLUGGED AND RE PLUGGED THE FO SENSOR CABLE ONCE BEFORE. ESP PERSONNEL ASKED HER TO REPEAT THE STEP, VERIFYING THAT IT WAS ARROW TO ARROW AND SEATED APPROPRIATELY. ESP PERSONNEL THEN REVIEWED THE STEPS TO TRANSITION FROM FO TO TRANSDUCER AS THE PRESSURE SOURCE AND REQUESTED SHE COIL, TAPE AND LABEL THE FO CABLE AS FIBER OPTIC SENSOR FAILURE. DO NOT USE. MINIMAL COMPLAINT INFORMATION OBTAINED AS NURSE DID NOT WISH TO RETRIEVE ALL THE INFORMATION. SHE WAS APPRECIATIVE OF THE SUPPORT AND DENIED ANY ADDITIONAL NEEDS. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895176 ↗
• MalfunctionApr 16, 2026Device Sensing Problem

  IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT THE INTRA AORTIC BALLOON (IAB) SENSATION PLUS 50CC HAD A FIBER OPTIC SENSOR FAILURE ALARM. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893108 ↗
• MalfunctionApr 15, 2026Device Sensing Problem

  A COMPLAINT WAS RECEIVED VIA DIRECT CALL TO THE EMERGENCY SUPPORT PROGRAM REGARDING A SENSATION PLUS 50CC INTRA AORTIC BALLOON (IAB) OPTICAL SENSOR FAILURE ALARM. A NURSE REPORTED THE ALARM AND REQUESTED ASSISTANCE. TROUBLESHOOTING WAS PERFORMED, INCLUDING REMOVAL AND REINSERTION OF THE FO CABLE WITH PROPER ARROW ALIGNMENT. HOWEVER THE ALARM PERSISTED. NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884409 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED BY THE CUSTOMER VIA EMERGENCY SUPPORT PROGRAM LINE, THAT THE INTRA AORTIC BALLOON (IAB) SENSATION PLUS 50CC HAD LEAK, BLOOD IN TUBING & BALLOON RUPTURE. THERE WERE NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871792 ↗
• MalfunctionApr 13, 2026Pacing Problem; Device Sensing Problem

  (B)(6) AN ICU RN CALLED INTO THE EMERGENCY SUPPORT PROGRAM LINE ON BEHALF OF (B)(6) FELLOW REQUESTING ASSISTANCE FOR A DAMPENED ARTERIAL WAVEFORM. SHE REPORTED THAT THE PUMP WAS USING THE TRANSDUCER AS THE AP SOURCE DUE TO A FO SENSOR FAILURE. A SCREENSHOT OF THE IABP MONITOR REVEALED THE PUMP WAS IN SEMIAUTO MODE USING PRESSURE TRIGGER AN ECG WAVEFORM WITH SIGNIFICANT ARTIFACT AND AN ARTERIAL WAVEFORM WITH SIGNIFICANT ARTIFACT. (B)(6) STATED SHE HAD TROUBLESHOT THE ARTERIAL WAVEFORM BY FLUSHING EVERY FOUR HOURS AND HAD SUCCESSFULLY ASPIRATED AND REPLACED THE ENTIRE TRANSDUCER SETUP WITHOUT IMPROVEMENT. ESP PERSONNEL RECOMMENDED OBTAINING A CHEST X RAY TO ENSURE THE DISTAL MARKER WAS POSITIONED BETWEEN THE SECOND AND THIRD INTERCOSTAL SPACE. FOR THE ECG WAVEFORM ESP PERSONNEL RECOMMENDED REPLACING THE ECG ELECTRODES APPLYING DOPPLER GEL TO THE BACK OF EACH ELECTRODE OPTIMIZING ELECTRODE PLACEMENT TO IMPROVE CONDUCTION AND CONSIDERING A SWITCH BACK TO AUTOMODE. (B)(6) THE DAYSHIFT CHARGE RN LATER SENT A SCREENSHOT OF THE MOST RECENT CHEST X RAY WHICH SHOWED THE DISTAL MARKER IN THE FOURTH INTERCOSTAL SPACE. ESP PERSONNEL EXPLAINED GETINGE RECOMMENDED POSITIONING OF THE RADIOPAQUE MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24856460 ↗
• MalfunctionApr 13, 2026Pacing Problem; Device Sensing Problem

  THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER REGISTERED NURSE TO THE EMERGENCY SUPPORT PROGRAM IT WAS REPORTED THAT WHILE USING SENSATION PLUS 8FR 50CC INTRAAORTIC BALLOON IAB THE REPORTER CALLED FOR ASSISTANCE FOR FO SENSOR ALARM AND REPORTED THE BALLOON CATHETER HAD BEEN INSERTED SUCCESSFULLY IN THE CATH LAB THE REPORTER STATED HE HAD TROUBLESHOT THE ALARM BY REMOVING AND REINSERTING THE FO CABLE MULTIPLE TIMES WHICH DID NOT RESOLVE THE ALARM HE THEN SWITCHED TO THE INNER LUMEN SUCCESSFULLY AND REPORTED APPROPRIATE WAVEFORMS NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854411 ↗
• MalfunctionApr 13, 2026Leak/Splash; Material Rupture

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853928 ↗
• MalfunctionApr 13, 2026Migration or Expulsion of Device; Pressure Problem

  THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM. TROUBLESHOOTING WAS PERFORMED WITH THE NURSE AND DETERMINED THAT THE CATHETER WAS WORKING AS INTENDED. NO PATIENT HARM OR INJURY WAS NOTED. TROUBLESHOOTING IDENTIFIED THE NATURE OF THE ALLEGED ISSUE AND REVIEWED THAT THE CATHETER WAS FUNCTIONING APPROPRIATELY GIVEN THE PATIENT¿S CLINICAL PICTURE AND POSITION OF THE BALLOON. THE ALLEGED ISSUE WAS NOT RELATED TO A DEVICE MALFUNCTION, RATHER USER ERROR. AN RN IN THE CVICU, CALLED WITH LOW BLOOD PRESSURE AND HIGHER AUGMENTATION. SHE STATED THE PATIENT HAD JUST ARRIVED FROM THE CATH LAB A SHORT TIME AGO. SHREYA EXPLAINED THE PATIENT¿S BLOOD PRESSURE SEEMED LOWER THAN SHE WOULD EXPECT DESPITE THE MEAN BEING OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853852 ↗
• MalfunctionApr 11, 2026Device Sensing Problem

  IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT THE SENSATION PLUS 50CC HAD FIBER OPTIC (FO) SENSOR FAILURE ALARM OCCURRED IMMEDIATELY AFTER CATHETER PLACEMENT. ESP PERSONNEL INSTRUCTED AGGIE TO REMOVE THE FO CABLE FROM THE PUMP, AND TO REINSERT THE CABLE ENSURING THE ARROW ON THE FO CABLE AND THE ARROW ON THE PUMP ALIGN. AGGIE FOLLOWED THE INSTRUCTIONS MULTIPLE TIMES, HOWEVER THIS DID NOT RESOLVE THE ALARM. ESP PERSONNEL RECOMMENDED SWITCHING TO THE INNER LUMEN FOR THE AP SOURCE. AGGIE STATED SHE WOULD FOLLOW THESE RECOMMENDATIONS. SHE WAS UNABLE TO PROVIDE THE SN AT THE TIME OF CALL DUE TO PATIENT PRIORITIZATION. ESP PERSONNEL STATED HE WOULD FOLLOW UP WITH HER TO COLLECT THE INFORMATION. SHE APPRECIATED THE SUPPORT PROVIDED AND HAD NO OTHER QUESTIONS. ESP PERSONNEL FOLLOWED UP WITH AGGIE MULTIPLE TIMES AND WAS ABLE TO OBTAIN PRODUCT SURVEILLANCE INFORMATION ON THE BALLOON CATHETER. SHE STATED THE PHYSICIAN OPTED TO REMOVE THE SENSATION PLUS 50CC AND INSERT A MEGA 40CC. ESP PERSONNEL EXPLAINED THAT A BIOHAZARD KIT WOULD BE SENT TO THE MANAGER TO RETURN THE SENSATION PLUS 50CC BALLOON CATHETER BACK TO GETINGE DUE TO THE FO SENSOR FAILURE. NO HARM OR INJURY T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851471 ↗
• MalfunctionApr 10, 2026Leak/Splash

  A COMPLAINT WAS RECEIVED VIA A DIRECT CALL TO THE EMERGENCY SUPPORT PROGRAM REGARDING A GAS LOSS ALARM ON A CARDIOSAVE INTRA AORTIC BALLOON PUMP IABP. NO PATIENT INJURY OR ADVERSE OUTCOME WAS REPORTED.CLINICAL STAFF QUESTIONED WHETHER THE ALARM COULD BE RELATED TO A POTENTIAL BALLOON CATHETER PERFORATION. TROUBLESHOOTING GUIDANCE WAS PROVIDED, INCLUDING ASSESSMENT FOR SIGNS OF PERFORATION, POSSIBLE CLINICAL CONTRIBUTORS TO THE ALARM, INSTRUCTIONS TO RESTART THERAPY USING THE IAB FILL AND START KEYS, AND CONFIRMATION THAT THE HELIUM EXTENDER TUBING SHOWED NO BLOOD OR DISCOLORATION PRIOR TO RESUMING THERAPY.AT THE BEDSIDE, THE PATIENT WAS REPORTED TO BE NON INTUBATED AND MOVING FREQUENTLY, WITH VISIBLE PULSATION AT THE SHEATH INSERTION SITE. A CHEST X RAY WAS RECOMMENDED TO VERIFY BALLOON CATHETER POSITIONING. FOLLOW UP CONFIRMED THE X RAY SHOWED THE BALLOON CATHETER WAS MALPOSITIONED AND REQUIRED REPOSITIONING.PUMP IDENTIFICATION AND PATIENT INFORMATION WERE COLLECTED FOR PRODUCT SURVEILLANCE. CATHETER IDENTIFICATION COULD NOT BE CONFIRMED DUE TO DRESSING COVERAGE, THOUGH IT WAS NOTED TO BE AN FO IAB, 50 CC, BASED ON EXTENSION TUBING. THE EVENT WAS INTERNALLY REPORTED FOR AWARENESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838909 ↗
• MalfunctionApr 10, 2026Pacing Problem; Device Sensing Problem

  (B)(6), CVICU CALLED INTO EMERGENCY SUPPORT PROGRAM LINE TO REQUEST ASSISTANCE WITH A FIBER OPTIC SENSOR FAILURE ALARM ON A CARDIOSAVE CONSOLE DURING USE. (B)(6) REPORTS REMOVING THE FO SENSOR CABLE IN RESPONSE TO THE ALARM, AFTER WHICH THE TRANSDUCED ARTERIAL PRESSURE DISPLAYS A WAVEFORM WITH NO NUMERICAL VALUES. SHE ATTEMPTS INITIAL TROUBLESHOOTING PRIOR TO CONTACTING THE CLINICAL SUPPORT LINE BY SWITCHING TO A DIFFERENT PUMP, HOWEVER, THE ARTERIAL WAVEFORM IS FLAT WITH NO NUMERIC VALUES. ESP PERSONNEL GUIDE (B)(6) THROUGH ASPIRATING AND FLUSHING THE INNER LUMEN, WHICH DOES NOT IMPROVE THE AP WAVEFORM. ESP PERSONNEL THEN WALK HER THROUGH TROUBLESHOOTING THE TRANSDUCER SETUP USING A NEW CABLE AND ENSURING ALL CONNECTIONS ARE PROPERLY SECURED. THERE IS NO CHANGE IN AP WAVEFORM. ESP PERSONNEL RECOMMEND REPLACING THE TRANSDUCER SETUP ENTIRELY. (B)(6) CONFIRMS THE PRESSURE VALUES AND WAVEFORMS ARE NOW RESTORED AND APPROPRIATE FOLLOWING THIS INTERVENTION. THE BEDSIDE TEAM AGREES TO SECURE, COIL, AND LABEL THE FO CABLE WITH DO NOT USE AND RETURN THE CATHETER WHEN NO LONGER NEEDED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838384 ↗
• MalfunctionApr 7, 2026Inflation Problem; Leak/Splash; Pacing Problem

  (B)(6) RN CALLED INTO THE EMERGENCY SUPPORT PROGRAM LINE TO REQUEST SUPPORT FOR REVIEW OF AN AUTO R WAVE DEFLATE NOTIFICATION ON THE CARDIOSAVE DURING USE. WHEN ASKED WHETHER ANY ADDITIONAL ALARMS HAD BEEN PRESENT RECENTLY (B)(6) STATED THAT A GAS LOSS ALARM AND AN AUGMENTATION BELOW SET LIMIT ALARM HAD ALSO OCCURRED. SHE REQUESTED REVIEW OF POSSIBLE REASONS FOR ALL ALARMS. (B)(6) STATED SHE HAD VERIFIED NO BLOOD IN THE HELIUM TUBING AND THAT ALL CONNECTIONS WERE SECURE. SHE STATED THAT THE PATIENT WAS INTUBATED AND ON A PEEP OF 10 ON MULTIPLE MEDICATION DRIPS AND THAT THE PUMP WAS CURRENTLY PROVIDING THERAPY. ESP PERSONNEL REVIEWED POSSIBLE CLINICAL SCENARIOS THAT COULD CAUSE THE ALARMS AND WALKED HER THROUGH USE OF THE IAB FILL AND START KEYS TO RESTART THERAPY SHOULD A GAS LOSS ALARM OCCUR AGAIN. UPON COMPLETION OF THE REVIEW AND TROUBLESHOOTING AN UNABLE TO UPDATE TIMING ALARM SOUNDED. (B)(6) STATED THE PATIENT HAD A FIBER OPTIC CATHETER IN PLACE AND THAT IT WAS BEING TRANSDUCED. SHE STATED THE FO AP WAS THE CURRENT SOURCE OF ARTERIAL PRESSURE ON THE CARDIOSAVE. ESP PERSONNEL INSTRUCTED HER TO RECALIBRATE THE FIBER OPTIC SENSOR HOWEVER, THIS DID NOT IMPROVE AP QUALITY. ESP PERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799343 ↗
• MalfunctionApr 7, 2026Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT NURSE REQUESTING ASSISTANCE FOR A POSSIBLE BALLOON PERFORATION. NURSE REQUESTED REVIEW A SCREENSHOT WHICH REVEALED DISCOLORATION IN THE HELIUM TUBING. ESP PERSONNEL RECOMMENDED REMOVING THE HELIUM TUBING FROM THE PUMP, NOTIFYING THE PHYSICIAN AND TO PREPARE FOR BALLOON CATHETER REMOVAL. ESP PERSONNEL ALSO VISUALIZED A VIDEO THAT SHOWED BLOOD REACHING THE PUMP. ESP PERSONNEL TO NURSE THAT THE BALLOON CATHETER SHOULD NOT REMAIN INACTIVE FOR GREATER THAN 30 MINUTES DUE TO POTENTIAL RISK OF THROMBUS. ESP PERSONNEL WAS UNABLE TO COLLECT PRODUCT SURVEILLANCE AT THE TIME OF CALL DUE TO NURSE NEEDING TO PRIORITIZE PATIENT CARE AND ASKED HER TO KEEP THE CATHETER AND PUMP AT THE BEDSIDE. ESP PERSONNEL PROVIDED NURSE WITH HIS PHONE NUMBER AND ASKED HER TO CALL DIRECTLY SHOULD SHE HAVE ANY OTHER QUESTIONS OR THE NEED FOR TROUBLESHOOTING ASSISTANCE. ESP PERSONNEL FOLLOWED UP WITH NURSE, AND SHE REPORTED THE BALLOON CATHETER AND SHEATH HAD BEEN REMOVED SUCCESSFULLY. ESP PERSONNEL COLLECTED PRODUCT SURVEILLANCE AND EXPLAINED THAT A BIOHAZARD KIT WOULD BE SENT TO HER MANAGER AND REQUESTED THE CATHETER BE RETURNED TO GETINGE. ES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797091 ↗
• MalfunctionApr 6, 2026Failure to Calibrate

  TATUM, A PERFUSIONIST IN THE OR, CALLED FOR NO NUMBERS ON THE PUMP AFTER PLACING THE IABP IN THE OR. SHE STATED THAT THE PUMP DISPLAYED AN ¿UNABLE TO CALIBRATE¿ ALARM WITH NO NUMERICAL VALUES FOLLOWING INSERTION, ALTHOUGH PUMPING WAS CONFIRMED BY THE BALLOON WAVEFORM. THE ISSUE OCCURRED WHILE THE PATIENT WAS COMING OFF BYPASS AND RESOLVED AFTER APPROXIMATELY 30 MINUTES AS THE PATIENT¿S HEMODYNAMICS IMPROVED, WITH NUMERICAL VALUES RETURNING. BASED ON THE CLINICAL CONDITIONS, THE ISSUE WAS MOST LIKELY RELATED TO LOW PULSE PRESSURE RATHER THAN A DEVICE MALFUNCTION; NO OTHER ISSUES WERE REPORTED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788631 ↗