ARROW IPN915325Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10801902161977), received between Dec 1, 2022 and Aug 27, 2026 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K981660); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Inflation Problem; Failure to Pump

  When IABP "[Intra-Aortic Balloon Pump]" was inserted, console sounded like it inflated about 5 times- alarmed- then stopped. "Helium Loss" (Red alarm). Balloon would not inflate. Physician manually inflated IABP- no issues, attempted to run IABP again- same Red "Helium Loss" error. Team checked Helium tank just in case, everything was tight as it should be. Team switched balloon out for new balloon- new balloon worked as it should. No known harm to patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465554 ↗
• MalfunctionAug 26, 2026Inflation Problem; Failure to Pump; Therapeutic or Diagnostic Output Failure

  IABP "[intra-aortic balloon pump]" inserted into body per protocol. Pump turned on and began pumping. After 30 seconds to 1 min Balloon indicating red alarm error of Helium loss. Balloon not inflating under fluoroscopy. 100 CC of air injected and aspirated into balloon manually. Reconnected to helium line and machine started. Balloon pumped for 10-15 seconds and given helium loss error again. Balloon not inflating under fluoroscopy. Physician decided to put new balloon into patient. Balloons switched and hooked up to machine. Balloon and machine properly inflating and working.====================== Manufacturer response for System, balloon, intra-aortic and control, ARROW (per site reporter).======================Issue with RediGuard IABP balloons has been identified.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461890 ↗
• MalfunctionAug 25, 2026Inflation Problem; Biocompatibility; Misassembly by Users; Intermittent Loss of Power

  Right femoral access- no difficulty. Pump turned on 5-6 times then immediately error with red "Helium Loss". Console was switch out for a new console- same error persisted. Director contacted and came in to assist-Director called Teleflex hotline spoke with rep. Rep suggested to switch EKG cables- we did this - error still persisted. Rep asked us to turn on pump and during the 5-6 inflations (prior to the error shutting pump off) to see if we could see on fluoro if the balloon was indeed inflating. It was hard to tell but it looked like the balloon was not properly inflating. Rep requested facetime the hotline and rep did not like the "spikes" on the console screen and wanted to see the insertion site- rep doubted the color of the sheath saying we are not using a proper Teleflex Arrow Balloon pump sheath. Director proceeded to show rep an unopened sheath that matched what was in the patient. Then it was decided to put in a new balloon, scrub RN went through the prepping technique with Hotline- Rep advised we are prepping balloons 100% accurately. Once the new balloon was inserted, new balloon worked properly. Hotline call was ended.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438040 ↗
• MalfunctionAug 25, 2026Device Alarm System; Complete Loss of Power

  Access to right femoral artery no complication.IABP "[Intra-Aortic Balloon Pump]" inserted with fluoro, pump turned on, visualized full inflation. After 5-6 pumps Red "High Pressure" alarm; pump stopped. Patient was tachy and physician thought maybe the fast heart rate was throwing off IABP, he suggested switching from a ratio of 1:1 to 1:2. Same issue persisted. Balloon would pump 5-6 times then throw a "High pressure" red alarm. Double check under fluoro, and balloon was inflating. Physician chose to pull the sheath and balloon back in case there was a small kink. Same error. Perfusion was called into room for troubleshooting. Perfusion worked with physician and decided to decrease volume of air delivered into balloon- same error after 5-6 pumps. Perfusion decided to again decrease volume of air delivered into the IABP- balloon pump worked for 3-4 minutes then stopped again. Attempted to resolve issue for 20 minutes- decision was made based on patient condition to transition to Impella.

  Patient problems: Tachycardia

  MAUDE report 50438036 ↗
• MalfunctionDec 6, 2024

  AFTER TERMINATION FROM CPB (CARDIOPULMONARY BYPASS), A 40CC IABP CATHETER WAS PLACED UNDER TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) GUIDANCE. THE BALLOON WAS INITIATED; HOWEVER, FILL SUPPORT WAS NOT ACHIEVED AND THE BALLOON COULD BE VISUALIZED NOT FULL INFLATING. THIS IS A KNOWN ISSUE WITH THE FDA, THOUGH AFFECTED LOT NUMBERS HAVE NOT BEEN RECALLED. THE 40CC CATHETER WAS REMOVED AND ANOTHER CATHETER WAS PLACED TO PROVIDE SUPPORT.

  Patient problems: Insufficient Information

  MAUDE report 20864183 ↗
• MalfunctionApr 10, 2024

  MIDDLE-AGED MALE WITH ACUTE ONSET OF CHEST PAIN. PROCEDURE: HEART CATHETERIZATION. UPON INSERTION OF THE ARROW BALLOON, IT STARTED LEAKING BLOOD. DEVICE REMOVED AND ANOTHER ONE USED, WITHOUT KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR REDIGUARD IAB, REDIGUARD IAB (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078302 ↗
• MalfunctionAug 24, 2023Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT "IAB CATHETER WAS FOUND KINKED POST INSERTION AND BLOOD WAS NOTED IN THE CATHETER." 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. SEE ASSOCIATED MDR #3010532612-2023-00402.

  Patient problems: Insufficient Information

  MAUDE report 17617639 ↗
• MalfunctionAug 17, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT "DURING THE OPERATION, THE BALLOON PART OF THE AORTIC BALLOON CATHETER COULD NOT COMPLETELY PASS THROUGH THE FEMORAL ARTERY SHEATH". 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 17564093 ↗
• MalfunctionAug 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "A FEW HOURS AFTER THE CATHETER IS INSERTED, THE MACHINE SOUNDS AN ALARM. THE DEVICE WAS FOUND TO BE LEAKING BLOOD AND WAS REMOVED." AS A RESULT, 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 17563564 ↗
• InjuryAug 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ACUTE MYOCARDIAL INFARCTION. AFTER INSERTING AN IABP BALLOON CATHETER ON THE LEFT SIDE, CATHETER KINK WAS FOUND, AND THE CATHETER WAS IMMEDIATELY WITHDRAWN AND REPLACED WITH A NEW ONE". THE 2ND CATHETER WAS INSERTED AT A DIFFERENT INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541242 ↗
• MalfunctionAug 1, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED AS "IAB ABRASION/RUPTURE". THE REPORT STATES THAT BLOOD WAS NOTED IN THE HELIUM DRIVE LINE. AS A RESULT, THE IAB WAS REMOVED. A 2ND IAB WAS NOT INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435843 ↗
• MalfunctionAug 1, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THE CATHETER WAS INSERTED AND THEY NOTICED BLOOD RETURN IN THE HELIUM CONNECTION. THEY STOP THE PROCESS AND USED A NEW CATHETER BECAUSE THEY NOTICED THE TIP WAS BROKEN." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". 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 17434471 ↗
• MalfunctionJul 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER THE IAB WAS INSERTED, IT WAS FOUND TO BE KINKED. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THERAPY WAS INITIATED SUCCESSFULLY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398822 ↗
• MalfunctionJul 24, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE IAB WAS INSERTED, IABP THERAPY WAS INITIATED. AFTER 1 MINUTE OF PUMPING, IT ALARMED FOR "POSSIBLE HELIUM LEAKAGE". THE CATHETER AND INFLATION RATE WAS ADJUSTED TO 30CC BUT THE ALARMED PERSISTED. 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 17383675 ↗
• MalfunctionJul 19, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT, "CATHETER COULD NOT PASS-THROUGH GUIDE WIRE. BLOCKAGE IN CATHETER LUMEN SUSPECTED". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. 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 17354066 ↗
• MalfunctionJul 19, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PTCA WITH INITIATION OF IABP AND ECMO THERAPIES. "THE SURGEON IMPLANTED THE BALLOON THROUGH A SHEATH AND WAS UNABLE TO FULLY IMPLANT IT INTO THE IDEAL POSITION. HOWEVER, BY MOVING THE BALLOON BACK AND FORTH, IT WAS STILL UNABLE TO BE IMPLANTED INTO THE IDEAL POSITION. WITHDRAW THE BALLOON, CONNECT THE ONE-WAY VALVE, RETRACT THE EXHAUST, AND INSERT IT AGAIN, BUT IT CANNOT BE FULLY INSERTED. IMMEDIATELY WITHDRAW THE BALLOON AND DISCOVER THAT IT HAS BEEN FOLDED." AS A RESULT, A 2ND CATHETER 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 17353173 ↗
• MalfunctionMar 14, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED VIA TRANSLATION FROM ITALIAN TO ENGLISH THAT, "IABP POSITIONED ON 24.02 IN THE HEMODYNAMICS ROOM WITH MANEUVER US GUIDED AND SCOPY CONTROL IN PZ WITH SEVERE LOW FLOW RATE. THE DEVICE WAS REMOVED AFTER 72 HOURS DUE TO OCCLUSION OF THE CATHETER EVEN THE PATIENT HAS BEEN ADEQUATELY COAGULATED WITH HEPARIN SODICA E.V.". THE CATHETER WAS NOT REPLACED. NO REPORT OF PATIENT HARM OR INJURY. PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539245 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "ON (B)(6), AFTER PCI, THE PATIENT'S BLOOD PRESSURE WAS LOW, AND IABP WAS USED TO ASSIST. THE CATHETER WORKED NORMALLY. AT 8AM ON THE 18TH, THE CCU DOCTOR FOUND THAT THE BLOOD PRESSURE WAVEFORM DISPLAYED BY THE MACHINE WAS VERY LOW. AFTER CHECKING, BLOOD WAS FOUND IN THE Y PART OF THE CATHETER. AS THE PATIENT WAS IN DANGER, IT WAS NOT POSSIBLE TO STOP THE MACHINE AND REPLACE THE CATHETER. THE CCU DOCTOR CUT THE PROTECTIVE FILM TO STICK ON THE Y PART. THEN THE Y-SHAPED PART WAS WRAPPED WITH STERILE FILM, AND THE MACHINE WAS REMOVED AT 8 PM ON THE 19TH. THE PATIENT WAS IN GOOD CONDITION." NO HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438981 ↗
• InjuryFeb 21, 2023Positioning Problem; Positioning Problem

  THE REPORT STATES, "SPLENIC AND RENAL EMBOLIZATION (CONFIRMED BY ABDOMINAL TAC SCAN) WITH SEVERE DEVELOPMENT OF ACUTE KIDNEY INJURY, OCCURRED 9 DAYS AFTER CATHETER PLACEMENT." AS A RESULT, THE IAB WAS REMOVED. ANOTHER IAB WAS NOT INSERTED. ADDITIONAL INFORMATION STATES THAT "THERE IS NOT A SPECIFIC ISSUE OF THE CATHETER, THEY HAD NEVER SEEN ALL THE PHYSICAL ALTERATIONS WHILE USING AN IAB CATHETER". THE CURRENT PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16408543 ↗
• InjuryFeb 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "DURING USE, SUDDEN BLEEDING FROM THE CATHETER INTRODUCER WITH EVIDENCE OF INTRODUCER RUPTURE." ADDITIONAL INFORMATION STATES THAT THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT A DIFFERENT INSERTION SITE. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388655 ↗
• InjuryFeb 15, 2023Break; Break

  "DURING INSERTION INTO THE AORTA, THE PEEL-AWAY OF THE CATHETER BROKE AND ANOTHER CATHETER HAD TO BE USED." ADDITIONAL INFORMATION STATES THAT A SECOND IAB WAS INSERTED AT A DIFFERENT INSERTION SITE. NO REPORTED HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 16380423 ↗
• MalfunctionFeb 15, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "ONLY THE BOTTOM PORTION OF THE BALLOON WAS INFLATING. REMOVED THE SHEATH AND BALLOON TOGETHER." AS A RESULT, THE IAB WAS REMOVED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THE IAB WAS NOT REPLACED. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380270 ↗
• MalfunctionFeb 7, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED AS "IAB REMOVED-POSSIBLE ABRASION". "[CLINICIAN] CALLED THE HOTLINE FOR ASSISTANCE WITH PERSISTENT HELIUM LOSS 2 ALARMS, THEY HAVE CONFIRMED PLACEMENT VIA X-RAY, CHANGED THE HELIUM TANK, THERE ARE NO NOTED CONNECT ISSUES OR LEAKS, NO BLOOD NOTED IN THE TUBING. THE PATIENT IS IN SINUS RHYTHM, AUTOPILOT MODE, ECG TRIGGER. ALARM HISTORY NOTED ONLY HELIUM LOSS 2 ALARM OCCURRING APPROXIMATELY EVERY 3 MINUTES. REQUESTED ALARM STRIP AND IT SHOWS NO NOTED KINKING, PARTIAL OBSTRUCTION, OR LARGE LOSS OF BASELINE. RN REPORTED THAT A 9F SHEATH 'NOT FROM THE IAB KIT' WAS USED FOR [RIGHT FEMORAL] INSERTION EARLIER IN THE DAY. SHE IS UNSURE WHY THIS SHEATH WAS USED. I EXPLAINED TO THE [CLINICIAN]THAT BASED ON THE BPW, THIS APPEARS TO BE A LEAK. WE DISCUSSED AND THEN PERFORMED A LEAK TEST (FACETIME UNAVAILABLE). HELIUM LOSS 3 ALARMS WITH LEAK TEST AT PUMP, PUMP EXCHANGED, LOW CONFIDENCE THAT LEAK TEST WAS PERFORMED ACCURATELY. I EXPLAINED A LEAK IN THE PUMP IS RARE BUT THAT EXCHANGING THE PUMP WOULD ENSURE THE ISSUE WAS NOT PUMP RELATED, THE HELIUM LOSS ALARMS CONTINUED ON THE SECOND PUMP. I EXPLAINED TO THE [CLINICIAN] THAT THIS CONFIRMS THE ISSUE IS CATHETER RELATED. I DISCUSSED THAT AL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313244 ↗
• MalfunctionFeb 7, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT "AFTER PCI, THE PATIENT'S BLOOD PRESSURE WAS LOW, INSERTED AN IAB FOR ASSISTANCE. WHEN THE CATHETER WAS INSERTED INTO THE BODY, THERE WAS RESISTANCE. WHEN THE PUMPING STARTED, IT WAS FOUND THAT THERE IS NO BLOOD PRESSURE WAVEFORM DISPLAY, CHECKED THE CENTRAL CAVITY CONNECTION IS CORRECT, AND THEN REPLACED THE CATHETER WITH ANOTHER IAB-S730C. THE CATHETER ENTERS THE BODY SMOOTHLY, THE EQUIPMENT WORKS NORMALLY, THE BLOOD PRESSURE WAVEFORM DISPLAY IS NORMAL, AND THE PATIENT'S CONDITION IS STABLE." NO PATIENT HARM OR INJURY, PATIENT STATUS REPORTED AS "FINE". THE SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE. SEE ASSOCIATED MDR 3010532612-2023-00084

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311871 ↗
• MalfunctionFeb 7, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT "AFTER PCI, THE PATIENT'S BLOOD PRESSURE WAS LOW, INSERTED AN IAB FOR ASSISTANCE. WHEN THE CATHETER WAS INSERTED INTO THE BODY, THERE WAS RESISTANCE. WHEN THE PUMPING STARTED, IT WAS FOUND THAT THERE IS NO BLOOD PRESSURE WAVEFORM DISPLAY, CHECKED THE CENTRAL CAVITY CONNECTION IS CORRECT, AND THEN REPLACED THE CATHETER WITH ANOTHER IAB-S730C. THE CATHETER ENTERS THE BODY SMOOTHLY, THE EQUIPMENT WORKS NORMALLY, THE BLOOD PRESSURE WAVEFORM DISPLAY IS NORMAL, AND THE PATIENT'S CONDITION IS STABLE." NO PATIENT HARM OR INJURY, PATIENT STATUS REPORTED AS "FINE". THE SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE. SEE ASSOCIATED MDR 3010532612-2023-00083.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981660. One submission often covers many models, so check the product and lot details in each record.

• Z-1063-2016 · Feb 10, 2016 · Terminated
  Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during dia
• Z-1061-2016 · Feb 10, 2016 · Terminated
  RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto