ARROW IPN000255Recalls & reported problems
Teleflex Incorporated · Ultra 8(R) IAB · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a Teleflex Ultra 8 intra-aortic balloon pump catheter, used to support the heart in critical care. The 32 reports mostly describe the pump alarming about high pressure and possible helium loss, along with gas, fluid or blood leaks, and in one case a rupture of the balloon membrane that required replacing the catheter. Three reports involve injuries and no deaths were reported. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801902010759), received between Mar 1, 2019 and Nov 25, 2025 — classified as 3 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (6 reports).
27 other recalls cover devices cleared under the same FDA submission (K000729); 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
- Device Alarm System6
- Gas/Air Leak6
- Fluid/Blood Leak4
- Leak/Splash4
- Inflation Problem2
- Patient Device Interaction Problem2
- Break1
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient8
- Insufficient Information2
- Calcium Deposits/Calcification1
- Death1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Pressure Problem; Pressure Problem
IT WAS REPORTED THAT " PERSISTENT HIGH PRESSURE AND POSSIBLE HELIUM LOSS ALARM 3. ALARM HISTORY ON IABP #3 SHOWED 2-3 HIGH PRESSURE AND POSSIBLE HELIUM LOSS 3 ALARMS PER MINUTE. THIS WAS THE THIRD PUMP, [PER USER] THE ALARMSWERE THE SAME ON THE OTHER TWO PUMPS FOR ~2 HOURS PRIOR.DUE TO THE IAB REMAININGMOSTLY DORMANT FOR THOSE 2 HOURS AND THE INABILITY TO PUMP THE IAB, RECOMMENDATION FOR REMOVAL MADE. THE INTENSIVIST CAME TO THE BEDSIDE". ADDITIONAL INFORMATION STATES THAT THE IAB WAS PLANNED TO BE REMOVED, HOWEVER THERE WAS NO FOLLOW UP INFORMAITON PROVIDED BY THE CUSTOMER ON PATIENT CONDITION AND THE OUTCOME OF THE REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646247 ↗MalfunctionNov 25, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED " THE IAB WAS INSERTED VIARIGHT FEMORAL ARTERY. THE IABP ISSUED "POSSIBLE HELIUM LOSS 2" ALARMS AND BLOOD WAS FOUND IN THE PROTECTIVESLEEVE OF THE IAB AND HELIUM DRIVELINE". ADDITIONAL INFORMAITON STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED DUE TO THE PATIENT BEING STABLE WITHOUT THERAPY. THE PATIENT'S CURRENT CODNITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645184 ↗MalfunctionOct 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED "IAB RUPTURE". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".
Patient problems: Insufficient Information
MAUDE report 23267244 ↗MalfunctionJun 24, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED "CONSTANT HIGH-PRESSURE ALARMS IAB REMOVED". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22321224 ↗MalfunctionJun 5, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED "FREQUENT POSSIBLE HELIUM LOSS 2 ALARMS. THEY ARE COMING EVERY 2-3 MINUTES". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER FAILED THE LEAK TEST. TELEFLEX SALES REP RECCOMENDED THAT THE IAB CATHETER SHOULD BE REMOVED. IT IS UNKNOWN IF THE IAB CATHETER WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153229 ↗MalfunctionJan 8, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED "SUSPECTED IAB MEMBRANE FAILURE". ADDITIONAL INFORMATION STATES THAT TO CONTINUE THERAPY, THE IAB CATHETER WAS REMOVED AND REPLACED. THE SECOND CATHTETER WAS INSERTED INTO THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CODNITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103049 ↗MalfunctionJan 2, 2025Device Alarm System; Device Alarm System
IT WAS REPORTED "PERSISTENT HELIUM LOSS 2 ALARMS'. ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED DUE THE PATIENT NO LONGER NEEDING IAB SUPPORT. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 21054987 ↗MalfunctionNov 26, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED "SUSPECTED IAB ABRASION". ADDITIONAL INFORMATION STATES THE CATHETER WAS REMOVED AND NOT REPLACED AND THAT " PATIENT WILL BE MANAGED MEDICALLY". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20779892 ↗InjuryNov 4, 2024Device Alarm System; Detachment of Device or Device Component; Noise, Audible; Device Alarm System; Detachment of Device or Device Component; Noise, Audible
IT WAS REPORTED THAT: "IAB HUB DISCONNECTED FROM STERILE COVERING, DRIPPING NOISE FROM IAB. INITIAL CALL TO HOTLINE AT 2138 FOR "DRIPPING NOISE" FROM IAB. THERAPY APPROPRIATE, NO BLOOD OR CONDENSATION IN DRIVELINE. CONDENSATION DRAIN EMPTIED AND DRIVELINE PURGED WITH NO CHANGE. 2200 XRAY VERIFIED PLACEMENT. NOISE STOPS WHEN THERAPY PAUSED. NO KNOWN VALVE ISSUES I.E. INSUFFICIENCY, STENOSIS. NO RECENT ECHO AVAILABLE. NO KNOWN ANEURYSMS. VISUALIZED MUCUS BUILDUP IN INLINE ETT SUCTION AND RECOMMENDED CLEARING THE LINE. NO FURTHER REPORTS OF THE NOISE FROM THE IAB. ADDITIONAL CALL AT 0630 (B)(6) 2024 D/T HELIUM ALARMS. BY 0630, REPORTED NOISE NO LONGER AUDIBLE. STAFF EXPERIENCING REPEATED HELIUM LOSS 2 AND 3 ALARMS WITHIN SECONDS OF ATTEMPTING TO RESUME IABP THERAPY. ON FACETIME, PATIENT'S HIP REMAINS HYPEREXTENDED. NO BLOOD IN DRIVELINE. BPW APPEARS SQUARED OFF. PER THE RN, THERE WERE OCCASIONAL HELIUM ALARMS PRIOR TO THE PATIENT'S BATH, BUT ALARMS BECAME "NEARLY CONSTANT" AFTERWARDS. KYLE MENTIONED THE IAB APPEARED LOW ON THE XRAY FROM (B)(6) MORNING. I ASKED TO SEE THE IAB SITE AND VISUALIZED THE HUB HAD DISCONNECTED FROM THE STERILE COVERING AND BEEN PULLED DISTALLY. STAFF WAS UNAB
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20596912 ↗MalfunctionFeb 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED " IAB RUPTURE". ADDITIONALLY IT WAS REPORTED THAT THE USER NOTED "BLOOD SPECKS" IN THE DRIVELINE. THE USER ALSO NOTED A SINGLE HELIUM LOSS ALARM AND PURGE FAILURE ALARMS NOTED AS HAVING OCCURED RIGHT AFTER INSERTION. THERAPY WAS STOPPED AND IAB DISCONTINUED. PATIENT WAS REVALSCULARIZED IN THE OR VIA PLANNED CABG. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CURRENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18744048 ↗MalfunctionFeb 8, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT "FREQUENT HELIUM LOSS 2 ALARMS POSSIBLE IAB ABRASION". ADDITIONALLY, IT WAS REPORTED " PERSISTENT HELIUM ALARM LOSS 2 ALARMS OCCURRING EVERY 60 SECONDS OR LESS. THE IAB WAS JUST INSERTED IN THE CCL, THERE IS NO BLOOD NOTED IN THE TUBING. THEY HAD ALREADY BEGAN SWITCHING OUT THE PUMP PRIOR TO [CALLING SUPPORT]. THE ALARM CONTINUED ON THE SECOND PUMP. FACETIME ASSESSMENT NOTED ONLY SLIGHT PARTIAL OBSTRUCTION ON BPW, NSR, DECREASED IAB VOLUME TO 35CC AN ATTEMPTED 1:2, HELIUM ALARMS PERSISTED, MD AGREED WITH IAB REMOVAL. IAB WAS REMOVED WITHOUT INCIDENCE OR DIFFICULTY AND REPLACED WITH A SECOND IAB. NO ADDITIONAL ALARMS AFTER REPLACEMENT. PATIENT TRANSFERRED TO ICU, NO ADDITIONAL ALARMS." NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CURRENT CONDITION REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18672192 ↗MalfunctionJan 9, 2024Burst Container or Vessel; Burst Container or Vessel
THE REPORT STATES "POSSIBLE IAB MEMBRANE FAILURE". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18479826 ↗MalfunctionNov 30, 2023Inflation Problem; Inflation Problem
IT WAS REPORTED THAT "IAB CATHETER DID NOT APPEAR TO FULLY INFLATE". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18237011 ↗MalfunctionNov 8, 2023Inflation Problem; Inflation Problem
REPORTED AS "DISTAL 1/3 OF IAB FAILED TO UNWRAP, VISUALIZED ON FLUOROSCOPY". THE REPORT STATES " THE IAB WAS NOT UNWRAPPING AT THE D ISTAL END AFTER INSERTION. MANUAL INFLATION COMPLETED AND SUCCESSFUL. THEY RE-INITIATED. IAB TO REMAIN IN PLACE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18096754 ↗MalfunctionAug 25, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT APPROXIMATELY 60 HOURS INTO PATIENT BEING ON THE PUMP, THE BALLOON RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED. A 2ND CATHETER WAS NOT INSERTED AS THE PATIENT NO LONGER NEEDED IABP THERAPY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17625009 ↗MalfunctionAug 22, 2023Failure to Pump; Failure to Pump
REPORTED AS "BALLOON FAILED TO UNWRAP". THE REPORT STATES THAT WHILE ATTEMPTING TO INITIATE PUMPING IMMEDIATELY AFTER INSERTION, "[COMPETITOR PUMP] WOULD ALARM FOR 'FAILURE TO AUTOFILL' WHENEVER THEY WOULD ATTEMPT TO PUMP. THE TECH ASSISTING WITH INSERTION STATED THAT THEY HAD ALREADY TRIED TO MANUALLY INFLATE THE BALLOON TWICE, BUT HE WAS MEETING RESISTANCE WHEN ATTEMPTING TO DO SO. [THE DOCTOR] CHOSE TO REMOVE THE IAB AND REPLACE IT WITH ANOTHER SUCCESSFULLY. HOWEVER THE [COMPETITOR PUMP] AGAIN WAS GIVING THEM AN ALERT FOR 'FAILED AUTOFILL'. THEY THEN GOT A SECOND PUMP, AND THIS PUMP WORKED WITHOUT ANY ISSUES AND THERAPY WAS INITIATED". NO PATIENT HARM OR INJURY. THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17599285 ↗MalfunctionMay 9, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT THE STAFF RECEIVED POSSIBLE HELIUM LOSS ALARMS. THERE WAS A DROP TO THE BASELINE OF THE BPW WHEN IT ALARMS; HOWEVER, THE BPW OTHERWISE LOOKED NORMAL. THERE WAS NO BLOOD IN THE GAS TUBING AND ALL THE CONNECTIONS WERE WELL SECURED. THE IAB DID FAILED THE LEAK TEST. AS A RESULT, THE IAB WAS REMOVED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14336461 ↗InjuryApr 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE STAFF RECEIVED A HIGH-PRESSURE ALARM. THERE WERE "NO OBVIOUS KINKS OR EVIDENCE OF COMPROMISED CATHETER. PUMP RESTARTED, AND HIGH-PRESSURE ALARM TRIGGERED AGAIN A FEW MINUTES LATER." IT WAS NOTED THAT THERE WAS A LIGHT SPECK OF BLOOD OBSERVED IN THE GAS DRIVELINE. AS A RESULT, THE PUMP WAS STOPPED, AND THE CATHETER WAS REMOVED BY THE SURGEON. PATIENT IS NOW HEMODYNAMICALLY STABLE BUT DEPENDENT ON INOTROPES AND INVASIVE VENTILATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978700 ↗MalfunctionMar 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT HIGH PRESSURE ALARMS OCCURRED INTERMITTENTLY BEFORE BLOOD WAS NOTICED COMING DOWN THE HELIUM DRIVELINE. AS A RESULT, THE CATHETER WAS REMOVED. IT WAS NOTED THAT THE PATIENT IS STABLE ON ECMO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13949911 ↗InjuryMar 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT THE BALLOON RUPTURED. THE STAFF HAD CALLED ABOUT DRAIN TASK INCOMPLETE ALARMS (APPROX. EVERY 20 MINUTES), WHICH WAS NOT RESOLVED WITH CYCLING THE PUMP'S POWER. THE CONDENSATION COLLECTION BOTTLE HAD VERY LITTLE CONDENSATE IN IT, AND THE STAFF NOTED BLOOD IN THE HELIUM DRIVELINE TUBING. IT WAS STATED THAT THE REMOVAL WAS DIFFICULT, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR FEMORAL REPAIR. THEY HAD TO PLACE A PATCH AT THE FEMORAL BIFURCATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13869472 ↗MalfunctionMar 19, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT HELIUM LOSS ALARMS OCCURRED DURING USE ON PATIENT. AS A RESULT, THE IAB WAS REPLACED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13825836 ↗MalfunctionJul 9, 2021Failure to Reset; Failure to Reset
IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON (IAB) WAS PLACED, THE CAL KEY READ "DEFECTIVE". THE USER TRIED TO TAKE IT OUT AND CLEAN IT OFF, REPLACE, FLIP OVER, ETC. BUT COULD NOT CLEAR THAT ALARM. AS A RESULT, THE PHYSICIAN REMOVED THE CATHETER AND CONSIDERED ANOTHER CATHETER BUT THEN WENT WITH THE IMPELLA DEVICE INSTEAD. THERE WAS NO REPORT OF DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12143826 ↗MalfunctionJun 3, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) CATHETER WAS NOTED KINK DURING PROCEDURE. THE IAB WAS UNABLE TO BE INSERTED. AS A RESULT, THE HOSPITAL STAFF OPEN UP A NEW IAB CATHETER AND THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11928968 ↗MalfunctionApr 14, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS FOUND LEAKING AFTER INSERTION. AS A RESULT, A NEW IAB WAS USED TO COMPLETE THE TREATMENT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11663891 ↗MalfunctionOct 5, 2020Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
IT WAS REPORTED THAT WHEN THE PATIENT ARRIVED FROM THE OR AND THE STAFF EXPERIENCED HELIUM LOSS 2 ALARMS. THE STAFF NOTED BLOOD IN THE TUBING AND THE INTRA-AORTIC BALLOON (IAB) WAS REMOVED. THERE WAS NO DIFFICULTY IN REMOVING THE IAB AND THE PATIENT WAS STABLED AFTER REMOVAL AND DISCHARGED FROM THE HOSPITAL. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10631181 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K000729. One submission often covers many models, so check the product and lot details in each record.
- Z-1880-2024 · Apr 29, 2024 · Open, ClassifiedArrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
- Z-1879-2024 · Apr 29, 2024 · Open, ClassifiedArrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
- Z-1060-2016 · Feb 10, 2016 · TerminatedUltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
- Z-1056-2016 · Feb 10, 2016 · TerminatedUltra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
- Z-1058-2016 · Feb 10, 2016 · TerminatedUltra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
- Z-1062-2016 · Feb 10, 2016 · TerminatedPercutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
- Z-1059-2016 · Feb 10, 2016 · TerminatedUltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
- Z-1065-2013 · Nov 27, 2012 · TerminatedArrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation th
- Z-1064-2013 · Nov 27, 2012 · TerminatedArrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation t
- Z-0792-2011 · Oct 11, 2010 · TerminatedFiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
- Z-0793-2011 · Oct 11, 2010 · TerminatedFiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
- Z-0791-2011 · Oct 11, 2010 · TerminatedArrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
- Z-0790-2011 · Oct 11, 2010 · TerminatedArrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
- Z-0969-2011 · Oct 11, 2010 · TerminatedPercutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
- Z-1212-2009 · Feb 2, 2009 · Terminated8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the a
…and 12 more.
Other System, balloon, intra-aortic and control devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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