ARROW IPN915319Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10801902167733), received between Dec 19, 2022 and Jan 16, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. Apr 29, 2024Open, Classified

   Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

   Z-1878-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025

  PATIENT UNDERWENT SUCCESSFUL PCI (PERCUTANEOUS CORONARY INTERVENTION) OF THE MID RIGHT CORONARY ARTERY WITH BALLOON ANGIOPLASTY 2 DAYS PRIOR. THIS TIME, PATIENT UNDERWENT IABP (INTRA-AORTIC BALLOON PUMP) INSERTION PRIOR TO A SCHEDULED CABG (CORONARY ARTERY BYPASS GRAFT). PER CARDIAC INTERVENTIONIST NOTES: AFTER INFORMED CONSENT, THE PATIENT WAS BROUGHT TO THE CCL (CARDIAC CATHETERIZATION LAB) IN STABLE CONDITION, DRAPED AND PREPPED IN THE USUAL MANNER. THE RIGHT FEMORAL ARTERY WAS ACCESSED UNDER ULTRASOUND GUIDANCE WITH A MICROPUNCTURE NEEDLE AND WIRE. A RIGHT FEMORAL ANGIOGRAM IS PERFORMED IN THE RAO (RIGHT ANTERIOR OBLIQUE) PROJECTION TO VERIFY APPROPRIATE ACCESS LOCATION. THE SHEATH IS EXCHANGED FOR THE 8-FRENCH IABP SHEATH. THE IABP IS THEN ADVANCED UNDER FLUOROSCOPIC GUIDANCE TO THE LEVEL OF THE AORTIC KNOB. AFTER PREPPING THE BALLOON PUMP, COUNTERPULSATION IS INITIATED. ALTHOUGH THE BALLOON IS VISUALLY SEEN TO INFLATE UNDER FLUOROSCOPY, THERE IS CONTINUED ALARMING OF THE CONSOLE. THEREFORE, THE BALLOON AND SHEATH WERE REMOVED OVER WIRE AND A NEW IABP IS ADVANCED UNDER FLUOROSCOPIC GUIDANCE. COUNTERPULSATION IS INITIATED AND BALLOON INFLATION IS VERIFIED UNDER FLUOROSCOPY. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168018 ↗
• MalfunctionSep 10, 2024

  AFTER GETTING INFORMED CONSENT, THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. CORONARY ANGIOGRAPHY WAS PERFORMED USING ACCESS OBTAINED IN THE RIGHT RADIAL ARTERY. THE RIGHT FEMORAL AREA WAS INFILTRATED WITH LIDOCAINE. A SWAN-GANZ CATHETER WAS THEN ADVANCED VIA THE RIGHT FEMORAL VEIN UNDER FLUOROSCOPIC GUIDANCE TO THE RIGHT PULMONARY CAPILLARY WEDGE POSITION. PLACEMENT OF AN IABP WAS DONE THROUGH THE RIGHT FEMORAL ARTERY. WHEN IT WAS TIME TO USE THE IABP FIBEROPTIX, THE DEVICE WON'T CALIBRATE. PHYSICIAN REQUESTED ANOTHER SIMILAR DEVICE AND THEY WERE ABLE TO PROCEED WITH NO FURTHER ISSUES. NO PATIENT HARM. MANUFACTURER RESPONSE FOR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL, ARROW (PER SITE REPORTER). GIVEN TO FIELD REPRESENTATIVE BY CCL MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180330 ↗
• InjuryNov 14, 2023

  IABP BALLOON POPPED DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18139872 ↗
• MalfunctionAug 8, 2023Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED THAT AFTER THE IAB WAS INSERTED AND PUMPING WAS STARTED, THE PUMP ALARMED FOR "HIGH PRESSURE". THE PATIENT WAS IMAGED UNDER FLUOROSCOPY, THE BALLOON DID NOT INFLATE COMPLETELY. TROUBLESHOOTING WAS ATTEMPTED HOWEVER IT WAS DETERMINED TO REMOVE THE IAB. AFTER THE IAB WAS REMOVED, IT WAS SEEN THAT BALLOON WAS "FAULTY". ANOTHER ATTEMPT WAS NOT MADE AS "NO SPARE IAC DUE TO CONSTRAINT. THE PATIENT WAS REFERRED TO A BIGGER CENTER FOR IVS RUPTURE SURGERY". NO PATIENT HARM OR INJURY. AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS OR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17483648 ↗
• InjuryMar 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO INSERT AN IAB INTO THE LEFT FEMORAL ARTERY, HOWEVER, THE IAB UNWRAPPED PREMATURELY AND WAS UNABLE TO BE ADVANCED FURTHER. AS A RESULT, A SECOND IAB WAS INSERTED AT A DIFFERENT INSERTION SITE, INTO RIGHT FEMORAL ARTERY. THE PATIENT WAS CRITICAL PRIOR TO THE EVENT. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598286 ↗
• MalfunctionFeb 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB RUPTURE, BLOOD CONFIRMED IN HELIUM DRIVELINE". AS REPORTED BY A TELEFLEX CLINICAL SUPPORT SPECIALIST, "[CLINICIAN] CALLED FOR BLOOD IN THE DRIVELINE. SOMEONE HAD TURNED THE PUMP BACK ON. I HAD THE [CLINICIAN] STOP THE PUMP, CLAMP DRIVELINE NEAR THE PATIENT, DISCONNECT DRIVELINE FROM THE PUMP. THE [CLINICIAN] CONFIRMED IT WAS A SUBCLAVIAN INSERTION SITE. FOS WAS WORKING AT TIME BLOOD WAS NOTED IN DRIVELINE. I RECOMMENDED REMOVAL OF IAB AS WELL AS QUARANTINING THE PUMP AND SEND IT TO BIOMED. I ASKED THE [CLINICIAN] TO KEEP THE CATHETER AFTER REMOVAL IN A BIOHAZARD BAG FOR RETURN, TO WHICH SHE AND PA WERE AGREEABLE AT TIME OF PHONE CALL." FURTHER INFORMATION STATES, "CT SURGEON DID NOT WANT TO REMOVE IAB D/T PATIENT CONDITION AND WILL DISCUSS NEXT STEPS WITH FAMILY. PUMP STOPPED, PROVIDERS LEAVING IAB OFF AND IN PLACE UNTIL TOMORROW. RISKS OF THIS DECISION WERE DISCUSSED. CURRENT PATIENT THERAPY CURRENTLY INCLUDES VA ECMO 'MAXED OUT' PER RN, CRRT. THIS IS PATIENT'S THIRD IAB. ALL IABS INSERTED VIA SUBCLAVIAN APPROACH". WHEN THE CLINICAL SUPPORT SPECIALIST INQUIRED FURTHER ABOUT THE EVENT, IT WAS UNKNOWN IF THE TWO PREVIOUS CATHETERS/IABS WERE TELEFLEX PRODUCTS, UNKNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427587 ↗
• MalfunctionFeb 9, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED AS "PERSISTENT HELIUM LOSS 3 ALARMS, ONE HIGH PRESSURE ALARM" AS REPORTED BY A TELEFLEX CLINICAL SUPPORT SPECIALIST, "[CLINICIAN] CALLED REGARDING REPEATED HELIUM LOSS 3 ALARMS. HE ENDORSED TEAM WOULD RESTART PUMP AND PUMP WOULD ISSUE ALARM WITHIN 3-4 BEATS. I HAD [CLINICIAN] CONFIRM THERE WERE NO VISIBLE EXTERNAL KINKS TO DRIVELINE OR CATHETER. HE ALSO DENIED ANY BLOOD IN THE DRIVELINE. RECENT XRAY AT 0200 PST VERIFIED CORRECT PLACEMENT. WE ATTEMPTED TO REPOSITION PATIENT WITHOUT ANY CHANGES TO ALARM FREQUENCY. VOLUME DECREASED TO 35CC AND 30CC WITHOUT CHANGES TO ALARM FREQUENCY. PUMP COULD BE HEARD ALARMING EACH TIME RESTART WAS ATTEMPTED. ALARM THEN BECAME "HIGH PRESSURE." ADDITIONAL XRAY WAS RECOMMENDED. WE DISCUSSED THE POSSIBILITY OF THE IAB HAVING A SEVERE KINK. MD OPTED TO REMOVE IAB". THEY DID NOT REPLACE THE IAB. NO PATIENT HARM OR INJURY, PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16336846 ↗
• MalfunctionFeb 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE IAB RUPTURED. AS A RESULT, THE IAB WAS REMOVED AND THERAPY WAS DISCONTINUED. THE PATIENT IS STABLE ON MINIMAL MEDICATION AT TIME OF EVENT. THERE IS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286739 ↗
• InjuryJan 31, 2023Material Integrity Problem; Material Integrity Problem

  IT IS REPORTED THAT "AN IAB WAS INSERTED IN THE PATIENT WITH ST ELEVATIONS + AND VENTRICULAR EXTRASYSTOLE [PREMATURE VENTRICULAR CON TRACTIONS]. IT CAN'T BE CALIBRATED TO ZERO, SO THE PROCEDURE HAS TO BE PAUSED, VENTRICULAR ASSISTANCE IS CONTINUED. THE CATHETER IS DISPLACED POSTERIORLY, WHEN THE PATIENT IS TRANSFERRED FROM THE OPERATING TABLE TO HIS ICU BED. A TRANSESOPHAGEAL ULTRASOUND PROBE HAD TO BE INSTALLED TO RELOCATE THE BALLOON". PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273904 ↗
• MalfunctionJan 31, 2023Inflation Problem; Inflation Problem

  AS REPORTED BY A TELEFLEX SALES REPRESENTATIVE: "BALLOON WAS INSERTED INTO PATIENT AND DIDN'T FULLY OPEN DURING INFLATION. I WAS TOLD ONLY THE BOTTOM HALF OF THE BALLOON INFLATED." AS A RESULT, A NEW BALLOON WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273225 ↗
• MalfunctionJan 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "BALLOON RUPTURE". AS REPORTED BY THE CLINICAL SUPPORT SPECIALIST: "RECEIVED A CALL FROM BIOMED ABOUT POSSIBLE BLOOD BACK IN THE AC3 FROM A BALLOON RUPTURE ON (B)(6)2023. I WAS ABLE TO GET SOME FURTHER INFORMATION FROM THE CLINICAL RESOURCE IN THE UNIT ABOUT THE SITUATION. THE PATIENT HAD AN AXILLARY INSERTION OF THE BALLOON ON (B)(6) 2022. ON EARLY MORNING (B)(6) 2023 THE STAFF FOUND BLOOD IN THE HELIUM TUBING. THE PHYSICIAN WAS NOTIFIED. THE PATIENT WAS TAKEN TO THE OR LATER THAT MORNING TO REMOVE AND REPLACE THE IAB. THERE WERE NO COMPLICATIONS WITH THE REMOVAL OR THE PATIENT. A SECOND FIBEROPTIC IAB WAS PLACED AXILLARY. THE PATIENT IS STABLE." NO PATIENT INJURY OR CONSEQUENCE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184254 ↗
• MalfunctionJan 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB RUPTURED, CHECK OUT REQUESTED FOR POSSIBLE BLOOD BACK". AS REPORTED BY THE FIELD SERVICE REP, "THIS PUMP WAS OBVIOUSLY ON PATIENT, BUT NO INTERVENTION REPORTED. AS FAR AS I KNOW, THE PATIENT WAS ALREADY DISCHARGED SINCE THIS HAPPENED BEFORE CHRISTMAS. COULD NOT DETECT ANY BLOOD UPON VISUAL INSPECTION. RAN UNIT FOR 1 HOUR. PERFORMED PM, NO PROBLEMS FOUND". INQUIRIES REGARDING HOW THE ISSUE WAS RESOLVED AND IF A SECOND CATHETER WAS INSERTED WERE UNANSWERED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157062 ↗
• MalfunctionJan 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "AXILLARY INSERTION BLOOD FLECKS NOTED IN GAS LINE". AS REPORTED BY THE CLINICAL SUPPORT SPECIALIST: "[PHYSICIAN] CALLED THE HOTLINE FOR ASSISTANCE TROUBLESHOOTING HELIUM LOSS ALARMS. IAB INSERTED YESTERDAY AFTERNOON VIA AXILLARY INSERTION AFTER REMOVING A FEMORALLY INSERTED IAB, HELIUM LOSS ALARM RECENTLY STARTED. I DISCUSSED THE ANGLE OF INSERTION AND DECREASING VOLUME TO IMPROVE GAS SPEED. ADDITIONAL DISCUSSION DETERMINED THERE IS BLOOD NOTED IN THE GAS LINE. (INFORMATION NOT INITIALLY PROVIDED). I DISCUSSED WITH THE [PHYSICIAN] THAT THE IAB SHOULD BE REMOVED AS THIS MEANS AN ABRASION IN THE IAB. WE DISCUSSED THAT THE AMOUNT OF BLOOD IS NOT RELEVANT, AND THAT THERE COULD BE LARGER AMOUNTS IN THE IAB AND RESULT IN CATHETER ENTRAPMENT. HE STATED HE WOULD DISCUSS WITH THE ATTENDING. FOLLOW UP CALLS WITH RNS, IAB WAS NOT REMOVED. STATED THAT THE MD CHOSE TO CONTINUE PUMPING AND THAT THE BLOOD WAS FROM INSERTION. I EXPLAINED THAT THIS IS NOT BLOOD FROM INSERTION, THAT THERE IS AN ABRASION OF THE IAB MEMBRANE AND EXPLAINED THE RISKS AGAIN. THE RN REPORTED THAT THEY DECREASED THE VOLUME TO 38CC AND THERE HAVE BEEN NO ADDITIONAL ALARMS. I EXPLAINED THAT THE RISK REMAINS THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137139 ↗
• MalfunctionJan 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB ABRASION CATHETER REMOVED". AS REPORTED BY THE CLINICAL SUPPORT SPECIALIST: "[CLINICIAN] CALLED THE HOTLINE FOR RE COMMENDATIONS ON ACTIONS WITH AN IAB ABRASION/RUPTURE. BLOOD WAS NOTED IN THE HELIUM DRIVE LINE AFTER AN ALARM OCCURRED ON THE PUMP. THE PATIENT WAS TRANSFERRED IN FROM JOHN MUIR WALNUT CREEK LAST NIGHT FOR SURGICAL EVALUATION. DURING OUR CONVERSATION, THE CATHETER WAS DISCONNECTED FROM THE PUMP, THERE APPEARS TO BE NO BLOOD BACK TO THE MACHINE, THE CATHETER WAS REMOVED IMMEDIATELY WITHOUT DIFFICULTY OR COMPLICATION. ANOTHER IAB IS NOT GOING TO BE INSERTED AT THIS TIME. DISCUSSED MONITORING FOR COMPLICATIONS POST REMOVAL. THE PATIENT REMAINED STABLE. FOLLOW UP CALL TO ACCOUNT, IAB NOT REINSERTED AT THIS TIME." PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086311 ↗
• InjuryJan 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED "WAS CALLED BY THE CLINICAL EDUCATOR AT 9:45 AM MT. HE STATED THAT HE HAD A BALLOON THAT RUPTURED AND THERE WAS DIFFICULTY REMOVING THE BALLOON. QUESTIONED IF THERE WAS ANY MATERIAL LEFT IN THE PATIENT, SO THE PATIENT WAS SENT TO THE OR FOR EXPLORATION. PATIENT IS CURRENTLY IN THE OR. THE PATIENT DID NOT HAVE ANY PRESSORS INFUSING PRIOR TO OR. THE PATIENT WAS STABLE." THE IAB WAS NOT REPLACED.

  Patient problems: Laceration(s)

  MAUDE report 16086255 ↗
• MalfunctionDec 22, 2022Inflation Problem; Inflation Problem

  AS REPORTED BY THE CLINICAL SUPPORT SPECIALIST: "CALLED BECAUSE THE DISTAL 1/3 OF THE BALLOON WAS NOT INFLATING DURING PUMPING. THE PATIENT IS GOING FOR CABG SURGERY TOMORROW. THE PATIENT'S HEART RATE IS 79 BPM. THERE WAS NO DIFFICULTY WITH INSERTION. WE TRIED TO DO SEVERAL MANUAL INFLATION AND DEFLATIONS. THERE WAS NO CHANGE. STILL COULD NOT SEE THE DISTAL 1/3 OF BALLOON INFLATING. THERE ARE NOT ALARMS ON THE PUMP, BUT THE BPW IS FAIRLY SQUARED. PHYSICIAN OPTED TO EXCHANGE THE BALLOON FOR ANOTHER BALLOON. SECOND BALLOON INSERTED WITHOUT DIFFICULTY. THEY USED THE SAME INSERTION SITE." NO REPORT OF PATIENT HARM OR INJURY. PATIENT CONDITION REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036097 ↗
• MalfunctionDec 19, 2022Gas/Air Leak; Gas/Air Leak

  REPORTED AS "FREQUENT, PERSISTENT HELIUM LOSS 2 ALARMS". "CALL PATCHED IN FROM SPEEDEZ. THE [CLINICIAN] CALLED THE HOTLINE FOR HELP WITH TROUBLESHOOTING MULTIPLE, PERSISTENT HELIUM LOSS 2 ALARMS. SHE SAID THAT THEY HAD JUST PLACED THE IAB IN THE CATH LAB A SHORT TIME AGO. THE PUMP IMMEDIATELY STARTED ALARMING FOR POSSIBLE HELIUM LOSS. THEY INITIALLY REDUCED THE VOLUME IN THE BALLOON FROM 50CC TO 40CC IN THE CATH LAB. THIS DID NOT CHANGE THE FREQUENCY OF THE ALARMS. THEY THEN TRIED SWITCHING TO A DIFFERENT PUMP. THE SECOND PUMP IMMEDIATELY STARTED ALARMING WITH THE SAME MESSAGE AS THE ORIGINAL PUMP. THEY THEN TRANSPORTED THE PATIENT TO THE CARDIAC ICU. THIS IS WHEN [THE CLINICIAN] CALLED THE HOTLINE. WE DISCUSSED THE FREQUENCY OF THE ALARMS. SHE SAID THAT THEY HAVE BEEN EVERY 3-5 MINUTES. THE PUMP WAS ALARMING IN THE BACKGROUND AND THE FREQUENCY, WHILE I WAS ON THE PHONE WITH HER, WAS CLOSER TO EVERY MINUTE. I ASKED IF WE COULD FACETIME, BUT THE PATIENT IS IN ISOLATION RELATED TO COVID. SHE DID SEND ME A PICTURE OF THE BPW WITH THE MOST RECENT ALARM. THE BPW APPEARED GROSSLY NORMAL WITH A VERY SLIGHTLY LOW BASELINE, WHICH APPEARED TO BE RIGHT AT ZERO. I EXPLAINED TO HER THAT MOST LI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16009324 ↗