ARROW IPN000302Recalls & reported problems
Teleflex Incorporated · Class 2
Quick summary
This Arrow IPN000302 is a balloon system used for intra-aortic balloon pumping, a machine that helps the heart pump blood. The 54 reports mostly describe power and battery trouble: the pump shutting down or the screen going black without an alarm, batteries draining quickly or failing during transport, and the device failing its power-on check. No deaths and no injuries are reported, and most events either happened before use or left care uninterrupted. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 30801902051722), received between Nov 16, 2018 and May 1, 2024 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (7 reports).
29 other recalls cover devices cleared under the same FDA submission (K060309); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem7
- Mechanical Problem7
- Failure to Run on Battery6
- Power Problem6
- Pumping Stopped5
- Unexpected Shutdown4
- Connection Problem3
- Device Alarm System3
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient12
- No Patient Involvement2
- Insufficient Information1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2024Display or Visual Feedback Problem; Power Problem; Display or Visual Feedback Problem; Power Problem
IT WAS REPORTED "IN THE PROCESS OF USING IABP, THERE WERE 2 TIMES WHEN THE INSTRUMENT SUDDENLY STOPPED WITH A BLACK SCREEN WITHOUT ANY ALARM. SUDDENLY BLACK SCREEN SHUTDOWN UNDER THE PROMPT, ABOUT 2 MINUTES AFTER RESTARTING CAN RUN NORMALLY. BECAUSE OF THE REPEATED BLACK SCREEN FAILURE OF THE DEVICE, THE PATIENT HAS BEEN REPLACED WITH A NEW DEVICE FOR TREATMENT." THE IABP WAS REMOVED AND REPLACED. NO DELAY OR INTERRUPTION TO THERAPY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226103 ↗MalfunctionMar 18, 2024Connection Problem; Connection Problem
IT WAS REPORTED "BEFORE USE, FOUND THAT THE DEVICE BATTERY IS QUICKLY FILLED, UNPLUG THE AC POWER, THE MACHINE WILL ALARM THE POWER IS LOW, THE COUNTER-BEAT QUICKLY STOPS, AND EVEN BLACK SCREEN SHUTDOWN." THIS EVENT HAPPENED PRIOR TO USE. NO PATIENT INVOLVEMENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 18921991 ↗MalfunctionFeb 15, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT DURING TRANSPORTATION OF A PATIENT ON BATTERY POWER, BATTERY POWER FAILED AND THE PUMP SHUT DOWN. ADDITIONAL IN FORMATION RECEIVED STATES THAT THE PATIENT DID NOT SUFFER ANY INJURIES. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712157 ↗MalfunctionFeb 15, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT DURING TRANSPORTATION OF A PATIENT ON BATTERY POWER, BATTERY POWER FAILED AND THE PUMP SHUT DOWN. ADDITIONAL IN FORMATION RECEIVED STATES THAT THE PATIENT DID NOT SUFFER ANY INJURIES. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712052 ↗MalfunctionFeb 15, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT DURING TRANSPORTATION OF A PATIENT ON BATTERY POWER, BATTERY POWER FAILED AND THE PUMP SHUT DOWN. ADDITIONAL IN FORMATION RECEIVED STATES THAT THE PATIENT DID NOT SUFFER ANY INJURIES. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712017 ↗MalfunctionFeb 15, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT DURING TRANSPORTATION OF A PATIENT ON BATTERY POWER, BATTERY POWER FAILED AND THE PUMP SHUT DOWN. ADDITIONAL IN FORMATION RECEIVED STATES THAT THE PATIENT DID NOT SUFFER ANY INJURIES. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711944 ↗MalfunctionFeb 15, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT DURING TRANSPORTATION OF A PATIENT ON BATTERY POWER, BATTERY POWER FAILED AND THE PUMP SHUT DOWN. ADDITIONAL IN FORMATION RECEIVED STATES THAT THE PATIENT DID NOT SUFFER ANY INJURIES. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711922 ↗MalfunctionFeb 9, 2024Battery Problem; Battery Problem
IT WAS REPORTED " BATTERY FAULT REPORTED AFTER POWER-ON SELF-TEST." THE DEFECT OCCURED PRIOR TO USE ON PATIENT DURING INSPECTION/FUNCTION TESTING. NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18681714 ↗MalfunctionJan 11, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT "AFTER THE POWER OUTAGE IN THE HOSPITAL, THE EQUIPMENT COULD NOT START UP NORMALLY, AND IT WAS DETECTED AS AN I INTERNAL BATTERY FAILURE". THE BATTERY FAILURE WAS FOUND PRIOR TO USE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18497695 ↗MalfunctionJan 9, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED THAT DURING USE ON A PATIENT, "THE PUMP KEEPS RINGING AND CANNOT WORK IN THE EARLY MORNING. ACCORDING TO THE ENGINEER'S GUIDANCE, TURN OFF THE BATTERY SWITCH AND RESTORE THE PUMP TO NORMAL. AFTER 10 MINUTES, THE DEVICE REAPPEARED WITH A BLACK SCREEN AND A LONG BEEP ALARM, MAKING IT UNABLE TO FUNCTION. THE ENGINEER DETERMINED THAT THERE WAS A PROBLEM WITH THE BATTERY MODULE". THE ISSUE WAS RESOLVED BUT EXCHANGING THE PUMP FOR ANOTHER. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION NECESSARY. PER THE CUSTOMER, THE PATIENT STATUS IS REPORTED AS "UNKNOWN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18476895 ↗MalfunctionSep 6, 2023Device Alarm System; Device Alarm System
IT WAS REPORTED THAT "THE DOCTOR ON DUTY NOTICED THAT THE EQUIPMENT DISPLAYED AN ALARM OF 'HELIUM LEAKAGE (4)' AND A CRASH OCCURRED (THE SCREEN SHOWED, BUT THE BUTTONS COULD NOT PERFORM THE OPERATION FUNCTION, AND THE EQUIPMENT COULD NOT BE USED NORMALLY). THE DOCTOR IMMEDIATELY REMOVED THE EQUIPMENT AND CATHETER. THIS MALFUNCTION OCCURRED DURING THE PATIENT'S TREATMENT PROCESS". ADDITIONAL INFORMATION STATES THAT THERE WAS NO VISIBLE DEFECT TO THE CATHETER. A NEW PUMP AND CATHETER WERE NOT INSERTED AS "THE DOCTOR USED OTHER TREATMENT AFTER REMOVAL OF THE EQUIPMENT AND CATHETER". NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17690538 ↗MalfunctionJul 26, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE IABP SCREEN "SUDDENLY APPEARED A WHITE SCREEN, THE MACHINE CANNOT RUN, AND IMMED IATELY REPLACED WITH ANOTHER MACHINE TO CONTINUE TREATMENT. PATIENT CONDITION LISTED AS FINE." NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17398850 ↗MalfunctionJul 26, 2023Pressure Problem; Pressure Problem
IT WAS REPORTED THAT "HIGH BASELINE ALARM, PRELIMINARY JUDGMENT OF CORE COMPONENT MOTOR FAILURE, REQUIRING REPLACEMENT OF MOTOR COMPONENTS. FOLLOW THE REPAIR PROCESS ACCORDING TO THE HOSPITAL'S PROCEDURE. THE MACHINE ALARM HIGH BASELINE WAS FOUND BEFORE USED ON THE PATIENT." NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17398471 ↗MalfunctionMay 1, 2023Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "THE PUMP WAS FOUND HELIUM LOSS, AND THE ENGINEERS IN THE HOSPITAL HAVE REPAIRED IT AND IT CAN BE USED NORMALLY." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIVED 10-MAY-2023 INDICATES NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16846055 ↗MalfunctionFeb 20, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIAC ARREST ON (B)(6) 2022 AND WAS PLACED ON ECMO. ON (B)(6) 2023 AN IAB WAS INSERTED. THE IABP ALARMED "SYSTEM ERROR 3" 6-10 TIMES EVERY DAY. THE MEDICAL STAFF RESTARTED THE IABP IN AN ATTEMPT TO FIX THE ALARM. ON (B)(6) 2023, THE IABP WAS SWAPPED OUT. THERE IS NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16403948 ↗MalfunctionFeb 14, 2023Complete Loss of Power; Complete Loss of Power
WHILE IN USE ON A PATIENT, THE REPORT STATES THAT "THE MACHINE STOPPED OPERATING SUDDENLY AND COULD NOT BE RESTARTED TO WORK NORMAL. AFTER THAT, THE DOCTOR DECIDED TO REMOVE THE CATHETER. THE PATIENT'S CONDITION DID NOT DETERIORATE SIGNIFICANTLY AFTER THE WITHDRAWAL OF THE MACHINE AND THE PATIENT'S FAMILY DECIDED TO GIVE UP THE TREATMENT AND DISCHARGED THE PATIENT FROM THE HOSPITAL. THE ENGINEER CHECK, THE MAIN ISSUE IS SYSTEM FAILURE DUE TO AGING OF VALVE SET COMPONENTS". FURTHER INFORMATION STATES THAT AFTER THE PATIENT WAS DISCHARGED, THE PATIENT DIED AT HOME. THE HOSPITAL DID NOT HAVE INFORMATION REGARDING THE DATE AND TIME OF DEATH. THE REPORTED CAUSE OF DEATH IS HEART FAILURE. DUE TO PATIENT PRIVACY, THE HOSPITAL WAS NOT ABLE TO DISCLOSE THE PATIENT'S MEDICAL HISTORY OR UNDERLYING MEDICAL CONDITIONS. ADDITIONAL INFORMATION STATES THAT WHEN THE STOP OPERATING, IT STOPPED PUMPING AND COMPLETELY SHUT OFF. IT ALSO STATES THAT THE PUMP WAS PLUGGED INTO A WALL OUTLET WHEN THIS EVENT OCCURRED. THE CUSTOMER IS UNABLE TO PROVIDE THE PUMP LOG FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16371610 ↗MalfunctionJan 12, 2023No Display/Image; No Display/Image
THE REPORT STATES THAT "THE PATIENT WAS ADMITTED AT 02:50 ON (B)(6) 2022. THE WHITE SCREEN APPEARED ABOUT 20 TO 30 MINUTES AFTER THE NORMAL IMPLANTATION. THE WHITE SCREEN LASTED ABOUT 20 TO 30 MINUTES. THE ENGINEER CHECKED THE INTERFACE, AND THEN RESTART THE PUMP, IT CAN WORK NORMALLY. THE PATIENT DIED AT 06:30 ON (B)(6) 2022." ADDITIONAL INFORMATION STATES THAT THE PHYSICIAN DOES NOT BELIEVE THAT THE PUMP CONTRIBUTED TO THE PATIENT'S DEATH. AFTER THE PUMP DISPLAYED A WHITE SCREEN, THE PUMP WAS ULTIMATELY SWAPPED OUT FOR A NON-TELEFLEX PUMP, THEN THE PATIENT EXPIRED. THE UNDERLYING DISEASE OF THE PATIENT'S CONDITION WAS HEART DISEASE. PER THE CUSTOMER, THE HOSPITAL DID NOT PROVIDE THE CAUSE OF DEATH. NO AUTOPSY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16150426 ↗MalfunctionDec 8, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT "ON (B)(6) 2022, IN THE DEPARTMENT OF CARDIOVASCULAR MEDICINE, AS THE PATIENT HAD AN ACUTE HEART [MYOCARDIAL] INFARCTION WITH SYMPTOMS OF CARDIOGENIC SHOCK, THE PHYSICIAN PREPARED TO INSERT A STENT IN THE INTRA-AORTIC BALLOON, AND IN THE PROCESS OF USE, THE MACHINE SUDDENLY STOPPED WORKING AND ALARMED". IT WAS DECIDED TO "ASSESS THE PATIENT'S CONDITION, IMMEDIATELY CHECK THE PATIENT AND THE LINE FOR ABNORMALITIES, CALL THE PHYSICIAN TO EXAMINE THE PATIENT, MONITOR CHANGES IN VITAL SIGNS, ASK THE PATIENT IF HE/SHE HAS ANY SYMPTOMS OF DISCOMFORT, PAY ATTENTION TO THE PATIENT'S HEMODYNAMICS. SUSPEND THE USE OF THE MACHINE AND REPORTED TO THE MEDICAL INSTALLATION OFFICE AT THE SAME TIME. AFTER RESTARTING THE PUMP, THE MACHINE CAN START NORMALLY". PATIENT CONDITION IS REPORTED AS "FINE". MULTIPLE ATTEMPTS WERE MADE TO THE ASK THE CUSTOMER CLARIFYING INFORMATION REGARDING THE ALARM THAT THE PUMP GAVE, IF THERE WERE ANY MEDICAL INTERVENTIONS, ETC. THE CUSTOMER DID NOT RESPOND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15939217 ↗MalfunctionNov 7, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT "THE BATTERY FAILED BATTERY LOAD TEST IN ACCORDANCE WITH SERVICE MANUAL (VOLTAGE LOWER THAN 11.8 V AFTER 60 MIN) DURING PREVENTATIVE MAINTENANCE. THE FAULTY BATTERY HAS BEEN PREVIOUSLY REPLACED IN 2021 (B)(6) 2021). THE BATTERY HAS BEEN REPLACED. THE MACHINE WAS RETURNED TO SERVICE. FAULTY BATTERY NOT AVAILABLE (DISPOSED BY HOSPITAL)". NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15746365 ↗MalfunctionOct 26, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT PRIOR TO USE THE MACHINE CANNOT BE STARTED. THE BATTERY CANNOT BE CHARGED. AFTER CHECK, THE BATTERY IS DAMAGED AND NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15673912 ↗MalfunctionSep 16, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "ON THE EVENING OF (B)(6) , THE EQUIPMENT WAS PUT INTO USE. ON THE MORNING OF AUGUST 13, IT WAS FOUND THAT THERE WAS NO GAS IN THE HELIUM CYLINDER. THE HOSPITAL URGENTLY BORROWED A BOTTLE OF HELIUM FROM (B)(6) HOSPITAL FOR REPLACEMENT, AND THE AGENT (B)(4) . ALSO SENT SOMEONE TO DRIVE A BOTTLE FROM (B)(6) FOR STANDBY. THE DEVICE WAS STOPPED FOR ABOUT 1 HOUR. AT ABOUT 5:00 P.M. ON AUGUST 13, THE DOCTOR FOUND THAT THE PRESSURE OF THE HELIUM GAS REPLACED IN THE MORNING HAD DROPPED TO LESS THAN 100PSI. HE CHECKED THE GASKET OF THE GAS CYLINDER AND THE GAS TRANSFER VALVE OF THE HELIUM CYLINDER, AND NO PROBLEM WAS FOUND. AFTER REPLACING THE WHOLE BOTTLE OF HELIUM, HE FOUND THAT THE GAS DROPPED RAPIDLY, AND IT WAS SUSPECTED THAT THE GAS PRESSURE REDUCING VALVE WAS FAULTY. AT 1:00 P.M. ON AUGUST 14, THE ENGINEERS OF NANJING QUANKANG TRADING CO., LTD. A RRIVED AT THE HOSPITAL AND REPLACED THE PRESSURE REDUCING VALVE ON THE HOSPITAL MACHINE WITH THE PRESSURE REDUCING VALVE ON THE COMPANY'S SAMPLE MACHINE. AFTER TESTING FOR 1 HOUR, THE GAS PRESSURE DROPPED BY 2PSI, WHICH WAS WITHIN THE NORMAL RANGE. WHEN THE EQUIPMENT WAS WORKING UNTIL NOON ON THE 14TH, THE GAS PRESSURE D
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15442701 ↗MalfunctionAug 22, 2022Device Alarm System; Device Alarm System
IT WAS REPORTED THAT "AT 17:00 ON JUNE 27 THE PATIENT RETURNED TO THE WARD AFTER PCI DUE TO ACUTE MYOCARDIAL INFARCTION, AND THE IABP WORK NORMALLY. THE PERIPHERAL BLOOD PRESSURE WAS ABOUT 100/70MMHG, AND THE HEART RATE WAS ABOUT 110 BEATS. AFTER ON JUNE 30 AT 20:00, THE MACHINE WAS STOPPED BY ALARM. THE INSPECTION DID NOT FIND ANY PROBLEMS. THE MACHINE WAS SHUT DOWN AND THEN RESTART TO WORK NORMALLY. UNTIL 13.30 ON JULY 1, THERE WAS AN ALARM. THE MACHINE COULD NOT BE RESTARTED AFTER BEING SHUT DOWN. THE MACHINE WAS REPLACED IMMEDIATELY". NO PATIENT INJURY, HARM, OR CONSEQUENCE. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15266972 ↗MalfunctionAug 22, 2022Device Alarm System; Mechanical Problem; Connection Problem; Device Alarm System; Mechanical Problem; Connection Problem
IT WAS REPORTED THAT "DURING USE, THE SYSTEM ERROR 3 ALARM, THE DRIVE BOARD IS POORLY CONNECTED, AND THE ENGINEER REPLACES THE DRIVE BOARD". ADDITIONAL INFORMATION RECEIVED STATED THAT THE PUMP WAS CHANGED. NO PATIENT HARM, INJURY, OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15266894 ↗MalfunctionAug 8, 2022Power Problem; Power Problem
IT WAS REPORTED THAT "THE DOCTOR FOUND THE PUMP CAN'T START UP NORMALLY, CAUSED BY POWER SUPPLY". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15189242 ↗MalfunctionJul 28, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT "DURING TRANSPORT, IT WAS FOUND THAT THE MACHINE BATTERY DID NOT SUPPLY POWER. AFTER THE PATIENT IS TRANSFERRED TO THE WARD, IABP USES AC POWER TO CONTINUE AUXILIARY SUPPORT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH". PATIENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15127110 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060309. One submission often covers many models, so check the product and lot details in each record.
- Z-0445-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
- Z-0446-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
- Z-0432-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
- Z-0429-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
- Z-0451-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
- Z-0449-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
- Z-0430-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
- Z-0453-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
- Z-0452-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
- Z-0448-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
- Z-0428-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
- Z-0450-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
- Z-0427-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
- Z-0454-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
- Z-0456-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
…and 14 more.
Other System, balloon, intra-aortic and control devices
- CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53Datascope Corp. · System, Balloon, Intra-Aortic And Control21 recalls39 deaths10,316 reports
- CS300 Intra-Aortic Balloon Pump, English, 110V 0998-00-3023-53Datascope Corp. · System, Balloon, Intra-Aortic And Control12 deaths3,164 reports
- CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls8 deaths1,686 reports
- CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls5 deaths1,181 reports
- CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52Datascope Corp. · System, Balloon, Intra-Aortic And Control19 recalls2 deaths1,157 reports
- SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) 0684-00-0576-01Datascope Corp. · System, Balloon, Intra-Aortic And Control2 recalls33 deaths1,541 reports
- CARDIOSAVE RESCUE 0998-00-0800-83Datascope Corp. · System, Balloon, Intra-Aortic And Control26 recalls167 reports
- CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls3 deaths456 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.