ARROW IPN038265Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10801902144208), received between Mar 31, 2022 and Sep 16, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788318 ↗
• MalfunctionSep 2, 2026Inflation Problem

  Patient problems: Insufficient Information

  MAUDE report 50566118 ↗
• MalfunctionOct 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "BLOOD IN HELIUM TUBING". ADDITIONAL INFOMATION STATES THAT THE IAB CATHETER WAS REMOVED AND IT IS UNKNOWN IF IT WAS REPLACED. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL INFORMATION RELATED TO THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23347167 ↗
• MalfunctionAug 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "CCL - FAILURE TO UNWRAP. FAILURE TO UNWRAP WHILE PLACING". ADDITIONAL INFORMATION STATES THAT MANUAL INFLATION WAS ATTEMPTED AND UNSUCCESSFUL IN AIDING THE IAB CATHETER TO UNWRAP". ANOTHER IAB CATHETER WAS INSERTED. THE LOCATION OF THE SECOND DEVICE IS UNKNOWN. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 22849560 ↗
• InjuryJun 3, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "PERSISTENT POSSIBLE HELIUM LOSS 3 ALARMS". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REMOVED AND REPLACED. THE SECOND IAB CATHETER WAS INSERTED INTO A DIFFERENT INSERTION SITE. 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 22134092 ↗
• MalfunctionMay 27, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "BALLOON WAS NOT FULLY INFLATED AT THE TIP". THE USER REMOVED THE BALLOON AND INSERTED ANOTHER. 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 22090886 ↗
• MalfunctionMar 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "REPORTED FAILURE TO UNWRAP.HAD IMMEDIATELY RECEIVED HIGH PRESSURE ALARMS. THERE WERE NO VISIBLE KINKS IN THE LINE AND TEE VERIFIED APPROPRIATE PLACEMENT. MANUAL INFLATION NOT ATTEMPTED.INITIAL IAB REMOVED AND REPLACED WITH NO FURTHER ALARMS RECEIVED. IAB VOLUME DECREASED INCREMENTALLY TO 45CC TO MAINTAIN PLATEAU PRESSURE WITHIN 25MMHG OF AUG. PATIENT REPORTED TO HAVE REMAINED STABLE THROUGHOUT". 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 21644434 ↗
• MalfunctionSep 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED "RUPTURED BALLOON". ADDITIONAL INFORMATION STATES TO CONTINUE THERAPY, A SECOND CATHETER WAS ISERTED. THE SECOND IAB CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 20217189 ↗
• MalfunctionSep 13, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED "CCL PLACED IAB AND STARTED RECEIVING HELIUM LOSS ALARMS, DECIDED TO REMOVE THE CATHETER. UPON REMOVAL [THE USER] OBSERVED 2 KINKS IN THE SHEATH. THEY DID NOT PLACE A NEW IAB. 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 20216717 ↗
• MalfunctionDec 21, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE PUMP WAS ALARMING FOR "CATHETER ALARMS" AFTER THE PATIENT RETURNED FROM THE OR. THE PATIENT IS CRITICAL, VENTILATED, HAS ATRIAL FIBRILLATION WITH EPISODES OF V-TACH ON DOBUTAMINE AND EPINEPHRINE AT HIGH DOSES. THE USER WAS UNABLE TO ASPIRATE FROM THE CENTRAL LUMEN. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372706 ↗
• MalfunctionNov 2, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "IAB PLACEMENT ATTEMPTED ON LF, NO ISSUES OR DIFFICULTY NOTED WITH INSERTION, CONSTANT HIGH PRESSURE ALARMS ON PUMP, PUMP EXCHANGED, HIGH PRESSURE ALARMS CONTINUED. VOLUME DECREASED TO 40CC. MANUAL INFLATION NOT ATTEMPTED DUE TO LACK OF VISUAL PLACEMENT (IN OR) CXR CONFIRMED PROPER PLACEMENT. 2ND IAB INSERTED ON RF WITH SAME RESULT. 2ND IAB WAS KEPT FOR RETURN PHOTOS SHOW IAB STILL TIGHTLY WRAPPED. [THE PERFUSIONIST] STATED HE ALSO ATTEMPTED TO INFLATE IAB WITH THE PUMP IN INTERNAL TRIGGER AFTER THE IAB WAS REMOVED. HIGH PRESSURE ALARMS STILL NOTED AND IAB DID NOT UNWRAP. PATIENT WAS MEDICALLY STABILIZED AND TRANSFERRED TO THE ICU WHERE HE REMAINED STABLE WITHOUT IAB PLACEMENT". SEE ASSOCIATED MDR #3010532612-2023-00628.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057917 ↗
• MalfunctionSep 7, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "AFTER INSERTION AND CONNECTION TO THE PUMP, A HELIUM LEAKAGE WAS NOTICED, AND THE CARDIOLOGIST DECIDED TO REMOVE THIS IAB AND PLACE A NEW ONE. NO HELIUM LEAKAGE WAS FOUND, AND THE THERAPY WAS CONTINUED". THE 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 17701132 ↗
• MalfunctionJun 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE "BALLOON WOULD NOT FULLY INFLATE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND IAB WAS INSERTED. 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. ASSOCIATED MDR #3010532612-2023-00320.

  Patient problems: Insufficient Information

  MAUDE report 17100753 ↗
• MalfunctionJun 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE "BALLOON WOULD NOT FULLY INFLATE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND IAB WAS INSERTED. 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 #3010532612-2023-00319.

  Patient problems: Insufficient Information

  MAUDE report 17099225 ↗
• MalfunctionJun 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED VIA A TWITTER POST THAT THERE WERE ISSUES ENCOUNTERED WITH AN "'ARROW IAB". AFTER FOLLOW UP WITH CUSTOMER IT WAS REPORTED THAT A 50CC BALLOON CATHETER WAS NOT INFLATING. AS A RESULT, A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099222 ↗
• MalfunctionMar 31, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT THE IAB WAS INSERTED WITHOUT DIFFICULTY OR INCIDENT, WHEN THE STAFF ATTEMPTED TO INITIATE PUMPING, HIGH PRESSURE ALARMS OCCURRED X2. THERE WERE NO NOTED KINKS AND THE IAB APPEARED TO NOT UNWRAP UNDER FLUOROSCOPY. THE MD OPTED TO EXCHANGE THE IAB. A SECOND IAB WAS INSERTED IN THE SAME SITE. THERE WAS MINIMAL DELAY AND THE PATIENT REMAINED STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967116 ↗

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-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
• 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