ARROW IPN000320Recalls & reported problems
Teleflex Incorporated · Class 2
Quick summary
This Teleflex Arrow intra-aortic balloon system is a heart-support pump that inflates a balloon in the aorta. Its 383 reports include 2 deaths and no injuries, and often describe console battery problems, gas or air leaks and alarms, with some reports of the pump stopping. Reports often record no patient harm. 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
- 383
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 383 adverse event reports that list this exact device (DI 30801902051715), received between Jul 12, 2018 and Jun 28, 2024 — classified as 2 deaths, 381 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (62 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 Problem62
- Gas/Air Leak55
- Device Alarm System42
- Incomplete or Inadequate Connection28
- Mechanical Problem25
- Pumping Stopped23
- Power Problem21
- No Display/Image17
Patient problems
- No Clinical Signs, Symptoms or Conditions209
- No Consequences Or Impact To Patient141
- Insufficient Information21
- No Patient Involvement9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Known Impact Or Consequence To Patient2
- Brain Injury1
- Ischemia1
Recent adverse event reports
The 25 most recent of 383 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED "FREQUENT PURGE FAILURE ALARMS". TO CONTINUE THERAPY THE IAB PUMP CONSOLE WAS EXCHANGED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19638642 ↗MalfunctionJun 21, 2024Device Alarm System; Device Alarm System
"IT WAS REPORTED THAT "WHEN SWITCHED ON AND WHEN CONNECTED TO THE MAINS, THE PUMP SIGNALS: BATTERY OPERATION ALARM". THIS ISSUE WAS FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19589297 ↗MalfunctionJun 5, 2024Computer Software Problem; Computer Software Problem
IT WAS REPORTED "PUMP SCREEN BLACK/APPEARED TO HAVE POWER BUTTONS ILLUMINATED, NO SCREEN". TO CONTINUE THERAPY THE PUMP WAS EXCHANGED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472000 ↗MalfunctionMay 22, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT "THE BPW LOOKED LIKE A SEVERE KINK AND WAS CONSISTENTLY BELOW THE BASELINE. THERE WERE NO ALARMS. THE AP WAVEFORM DID NOT SHOW ANY AUG, ONLY A "NORMAL" AP WAVEFORM. ALSO NOTED WHEN THE IAB WAS ON STANDBY, THE BASELINE OF THE BPW DID NOT GO TO THE HOME POSITION AND WAS "WAVY". WE INITIALLY DECREASED THE IAB VOLUME TO 28CC WITHOUT MUCH CHANGE IN THE WAVEFORM. I ALSO HAD HER REPOSITION THE PATIENT TO HYPER-EXTEND THE HIP WITHOUT RESOLUTION. I ASKED THE NURSE TO GET A SECOND PUMP CONSOLE AND CONNECT TO SEE IF THE SAME WAVEFORMS WERE PRESENT. THEY WERE. THE PATIENT'S PRESSURES WERE VERY LOW, AND HE WAS ON [LEVOPHED] AND [EPINEPHRIN]. I SUGGESTED SHE GET A STAT CXR AND CALL THE PROVIDER. I GAVE HER MY DIRECT NUMBER TO FOLLOW-UP. THE SURGEON CAME IN AND SUSPECTED AN AORTIC DISSECTION AND TOOK THE PATIENT TO THE OR FOR REMOVAL OF THE IAB AND REPAIR OF THE AORTA. PT HAD DISSECTION FROM THE AORTIC ROOT TO BEYOND THE RENAL ARTERIES AS WELL AS A "BLOWN" AV. THEY ALSO PERFORMED AN EXPLORATORY LAP ON HIM AND REMOVED HIS GALLBLADDER. THE PLAN IS TO GO ON CRRT POST OP. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED".
Patient problems: Insufficient Information
MAUDE report 19374802 ↗MalfunctionMay 21, 2024Power Problem; Power Problem
IT WAS REPORTED " THE PATIENT WAS ADMITTED TO OUR DEPARTMENT BECAUSE OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, AND HE UNDERWENT ECMO AND IABP CARDIAC ASSISTANCE, AND ON 04-15 IABP WAS SUDDENLY SHUT DOWN, SO HE WAS FORCED TO GET OFF THE PLANE, AND THE PATIENT'S CIRCULATION FLUCTUATED, AND VASOACTIVE DRUGS WERE ADDED TO MAINTAIN HIM". ADDITIONAL INFORMATION STATES "THE DEVICE WAS WORKING NORMALLY WHEN IT SUDDENLY STOPPED WORKING AND THE CLINICIAN OBSERVED THE PATIENT'S CONDITION AND CHOSE TO UNPLUG THE IABP, STILL RETAINING THE ECMO. THE PATIENT'S CONDITION WAS STABILIZED, THE ECMO WAS SUBSEQUENTLY WITHDRAWN, AND HE HAS RECOVERED AND BEEN DISCHARGED FROM THE HOSPITAL". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 19360371 ↗MalfunctionMay 1, 2024Battery Problem; Battery Problem
IT WAS REPORTED "BATTERY NOT CHARGING DESPITE SHOWING CHARGING UNDER STATUS, IABP STILL ALARMING". THE USER SWITCHED CONSOLES. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226102 ↗MalfunctionApr 29, 2024Computer Software Problem; Computer Software Problem
IT WAS REPORTED "BLANK DISPLAY. DISPLAY WAS DROPPED WHILE PUMP WAS ON PATIENT. PUMP WAS SWAPPED AND PATIENT WAS NOT HARMED. FOUND BLANK WHITE SCREEN UPON POWER UP".
Patient problems: Insufficient Information
MAUDE report 19201539 ↗MalfunctionApr 25, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT "DOES NOT POWER ON FROM AC". THIS EVENT HAPPENED PRIOR TO USE. NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19187822 ↗MalfunctionMar 25, 2024Power Problem; Power Problem
IT WAS REPORTED " BIO-MED RECEIVED A CALL OF PUMP SHUTTING OFF, (BELIEVE LOST POWER) BEEN RUNNING IN BIO-MED WITHOUT PROBLEMS BUT WOULD LIKE PUMP CHECKED OUT." ADDITIONAL INFORMATION STATES "CHECKED VOLTAGES AND BATTERY-CHECKED POWER SWITCH AND RESET CONNECTIONS ON SWITCH. TAPPED AROUND SWITCH (NEWEST STYLE SWITCH) SHAKE TESTED, COULD NOT EVEN GET SCREEN TO FLICKER. PREFORMED FUNCTIONAL CHECKS PASS ALL. PUMP HAD BEEN LEFT TURNED ON IN BIO-MED AND NO PROBLEM SEEN." THE PUMP WAS REPLACED WITH ANOTHER PUMP TO CONTINUE THERAPY. PATIENT'S CURRENT CONDITION IS UNKNOWN. NO PATIENT HARM OR INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 18970928 ↗MalfunctionMar 21, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT "THE INTERNAL BATTERY DOESN'T WORK AND THE PUMP DOES NOT WORK DETACHED BY THE MAIN LINE". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18949913 ↗MalfunctionMar 21, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT "THE INTERNAL BATTERY DOESN'T WORK AND THE PUMP DOES NOT WORK DETACHED BY THE MAIN LINE". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18949875 ↗MalfunctionMar 18, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED "PURGE FAILURE EVEN AFTER TROUBLESHOOTING". ADDITIONALLY IT WAS REPORTED " WHEN THE USE TRIED TO INITIATE SUPPORT THEY IMMEDIATELY GOT A PURGE FAILURE ALARM. ECG AND ARTERIAL PRESSURE WAVEFORM (FROM THE FIBEROPTIC) PRESENT. THE GAS TUBING WAS CONNECTED AND HERE WAS HELIUM. THE USER DOUBLE CHECKED THAT THE HELIUM WAS TURNED ON AND IT WAS. THE USER ATTEMPTED TO INITIATE PUMPING AGAIN AND GOT A SECOND PURGE FAILURE ALARM." TO CONTINUE THERAPY THE PUMP WAS SWITCHED WITH ANOTHER AUTOCAT 2 WAVE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CURRENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922138 ↗MalfunctionMar 14, 2024Failure to Charge; Connection Problem; Failure to Charge; Connection Problem
IT WAS REPORTED THAT PRIOR TO USE ON A PATIENT, "THE INTERNAL BATTERY DOESN'T WORK AND THE PUMP DOES NOT WORK DETACHED BY THE MAIN LINE". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18908602 ↗MalfunctionFeb 9, 2024Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT "STAFF HAD DIFFICULTY ACQUIRING ECG AND AP SIGNALS AND HAD PURGE FAILURE ALARMS WHEN ATTEMPTING TO INITIATE COUNTERPULSATION. I DID NOT FIND ANYTHING WRONG WITH THE PUMP OTHER THAN THE ROTATION LATCH ASSEMBLY WAS BEND, WHICH HAS NOTHING TO DO WITH WHAT THEY EXPERIENCED. THEY SWITCHED OUT THE PUMP AND I AM NOT AWARE OF ANY PATIENT COMPLICATIONS". SEE ASSOCIATED MDR # 30105 32612-2024-00118.
Patient problems: Insufficient Information
MAUDE report 18681399 ↗MalfunctionFeb 9, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT "STAFF HAD DIFFICULTY ACQUIRING ECG AND AP SIGNALS AND HAD PURGE FAILURE ALARMS WHEN ATTEMPTING TO INITIATE COU NTERPULSATION. I DID NOT FIND ANYTHING WRONG WITH THE PUMP OTHER THAN THE ROTATION LATCH ASSEMBLY WAS BEND, WHICH HAS NOTHING TO DO WITH WHAT THEY EXPERIENCED. THEY SWITCHED OUT THE PUMP AND I AM NOT AWARE OF ANY PATIENT COMPLICATIONS". SEE ASSOCIATED MDR #30105 32612-2024-00117.
Patient problems: Insufficient Information
MAUDE report 18681390 ↗MalfunctionFeb 8, 2024Battery Problem; Battery Problem
IT WAS REPORTED " ALARM: LOW BATTERY ALSO CONNECTED TO THE ELECTRICITY MAINS" IT IS REPORTED THAT THE DEFECT WAS DISCOVERED DURING IDENTIFIED DURING INCOMING INSPECTION/INVENTORY REVIEW. NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18672295 ↗MalfunctionJan 25, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT "ABNORMAL NOISE AND CONSEQUENT HELIUM LOSS SIGNAL BLOCK AND SUDDEN SHUTDOWN". AS A RESULT, THE PUMP WAS EXCHANGED FOR ANOTHER PUMP. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580902 ↗MalfunctionJan 11, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT "'HELIUM LOSS' ALARM DETECTED DURING PREVENTIVE MAINTENANCE". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18493349 ↗MalfunctionJan 10, 2024Power Problem; Power Problem
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE PUMP SUSTAINED A "SYSTEM 3 MALFUNCTION". AS A RESULT, THE PUMP WAS EXCHANGED FOR ANOTHER. ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT HARM OR INJURY, AND NO MEDICAL INTERVENTION NECESSARY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18486592 ↗MalfunctionJan 3, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT SYSTEM ERROR 7 AND HELIUM LOSS ALARMS WERE DETECTED DURING PREVENTIVE MAINTENANCE. NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 18439868 ↗MalfunctionNov 21, 2023Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT "[THE USER] CALLED THE HOTLINE TO DISCUSS THAT THE PUMP WAS FOUND TO BE IN THE OFF POSITION WITH NO ALARMS NOTED. THERE ARE NO ALARM STRIPS. SHE STATED UPON ENTERING THE PATIENT'S ROOM THE PUMP WAS FOUND TO BE IN THE OFF POSITION, POWER WAS STILL ON. SHE RESUMED PUMPING WITHOUT ISSUE BUT WANTED TO DISCUSS HOW LONG THE PUMP HAD BEEN DOWN AND THE POTENTIAL FOR CLOT FORMATION. [THE USER] STATED THAT AS BEST AS SHE CAN TELL BASED ON THE MONITOR INFORMATION AND THE AP WAVEFORM, THE PUMP WAS OFF FOR JUST UNDER 20 MINUTES THE PATIENT REMAINED STABLE THROUGHOUT. I DISCUSSED THE TIME LIMIT FOR IABC DORMANCY IN THE IFU AND SUGGESTED SHE DISCUSS THIS WITH THE MD. SHE ALSO STATED SHE WOULD LIKE TO SWITCH THE PUMP JUST IN CASE AND SEND IT TO BIOMED, ALTHOUGH IT IS CURRENTLY PUMPING WITHOUT ISSUE. SECOND CALL TO THE HOTLINE TO ASSIST WITH EXCHANGING THE PUMP AT 0329 EST". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18185977 ↗MalfunctionSep 28, 2023Device Alarm System; Device Alarm System
REPORTED AS "DRAIN FAILURE ALARMS X3 UNRESOLVED WITH TROUBLESHOOTING". THE REPORT STATES THAT THE USER CALLED "REGARDING 2 PURGE FAILURE ALARMS. HE ENDORSED THERE WAS NO EXCESSIVE CONDENSATION IN THE DRIVELINE, DRAIN BOTTLE HAD 1-2 CC AND WAS EMPTIED, AND DENIED BLOOD IN THE DRIVELINE. HE VERIFIED THE CONNECTIONS TO THE ARROW IAB AND DID NOT NOTE ANY VISIBLE KINKS OR CORRELATION WITH ECTOPY. DURING THE ALARMS, HE HAD NO CHANGES TO HIS ECG OR AP WAVEFORMS WITH THE IABP IN AUTOPILOT. HE ENDORSED THE HELIUM AS 'NEARLY FULL' WITH THE KNOB IN THE HELIUM COMPARTMENT FULLY OPEN. HE VERIFIED THERE WAS NO CONDENSATION BUILDUP IN THE DRIVELINE. MANUAL PURGE X2 ATTEMPTED. ON FACETIME, A THIRD AND FOURTH 'DRAIN FAILURE' ALARM ISSUED. NO ECTOPY AT THIS TIME AND PATIENTS HR 90-100. I ASKED IF THE PATIENT WAS TACHYCARDIC FOR ALL ALARMS AND HE STATED THE FIRST ALARM OCCURRED WITH THE HR 85-90 BPM. ECG AND AP WAVEFORMS APPROPRIATE WITH TRIGGER ACCEPTANCE NOTED. DRAIN BOTTLE EMPTY AND NO VISIBLE KINKS TO DRIVELINE OR EXTERNAL DRAIN TUBING. PATIENT LYING FLAT AND STILL WHEN ALARMS ISSUES WITH NO INDICATION OF A KINK IN THE BPW. I ASSISTED HIM IN MOVING CONNECTIONS TO THE SECOND IABP, WHICH RESOLVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17836079 ↗MalfunctionSep 28, 2023Output Problem; Output Problem
REPORTED AS "CONTINUED ECG INTERFERENCE". THE REPORT STATES THAT "THE IABP WAS DROPPING BEATS AND THEY HAD TO GO TO OPERATOR TO RESOLVE THIS, BUT IS NOW UNSURE OF THE TIMING. PATIENT IS IN AFIB WITH HR 55-90. MAP CAL COMPLETED TO ENSURE ACCURACY OF HEMODYNAMICS. MANUAL TIMING IN OPERATOR ATTEMPTED AND RESULTED IN REPEATED TIMING ERRORS, INCLUDING EARLY INFLATIONS/LATE DEFLATIONS WITH ARRYTHMIA. PUMP PLACED IN AUTOPILOT, WHICH CONTINUED TO HAVE DROPPED BEATS D/T VARIABLE QRS HEIGHTS. WE DISCUSSED THIS AND ITS IMPACT ON TIMING/THERAPY. LEAD SET ANALYSIS IS POOR AND WE DISCUSSED WHAT THIS MEANS. ECG STICKERS REPLACED AND MOVED ON PATIENT. TRUNK CABLE EXCHANGED. THE ACCOUNT DID NOT HAVE ANOTHER SET OF IABP ECG LEADS TO ATTEMPT. THERE WAS NO NOTABLE CHANGE TO THE LEAD SIGNAL OR ANALYSIS. SIGNALS MOVED TO SECOND IABP WITH IMPROVEMENT IN LEAD SET ANALYSIS AND WAVEFORM. IABP DROPPING BEATS WITH LESS FREQUENCY AND LEAD SET ANALYSIS IMPROVED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17835936 ↗MalfunctionSep 14, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT, "ERROR DETECTED BY HOSPITAL SERVICE ENGINEERS DURING CHECK. 'SYSTEM RUNNING ON BATTERY' ALARM WHEN SWITCHED ON EVEN IF CONNECTED TO THE MAIN; GREEN LED DOESN'T SWITCH ON POWER SUPPLY FAILURE". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17749481 ↗MalfunctionSep 12, 2023Power Problem; Power Problem
IT WAS REPORTED THAT "ERROR DETECTED BY HOSPITAL SERVICE ENGINEERS DURING EQUIPMENT ORDINARY CHECK. THE PUMP DISPLAYS 'SYSTEM RUNNING ON BATTERY' WHEN SWITCHED ON EVEN IF CONNECTED TO THE MAIN; GREEN LED DOESN'T SWITCH ON POWER SUPPLY FAILURE". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17731562 ↗
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-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-0456-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), 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-0431-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
- Z-0455-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), 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-0428-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), 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-0453-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
- Z-0426-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), 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-0452-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
- Z-0444-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
- Z-0451-2023 · Oct 17, 2022 · Open, ClassifiedArrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), 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.