ARROW IPN929208Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10801902218909), received between Apr 25, 2025 and Sep 14, 2026 — classified as 1 injury, 22 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K200634); 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764491 ↗
• MalfunctionAug 31, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531005 ↗
• MalfunctionAug 19, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327467 ↗
• MalfunctionAug 11, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202556 ↗
• MalfunctionAug 10, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195240 ↗
• MalfunctionJan 26, 2026Leak/Splash

  IT WAS REPORTED "SUSPECTED IAB ABRASION". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178285 ↗
• MalfunctionJan 16, 2026Leak/Splash

  REPORTED AS "POSSIBLE IAB RUPTURE". THE REPORT FURTHER STATES, "[USER] IS CALLING FROM THE CCL. THEY HAVE A PATIENT WITH LEFT MAIN DISEASE WHO THEY HAVE JUST PLACED A 30 CC LWS IAB IN THE R FEM OF A 4 FT 11 IN / 69 KG F PT. APPROXIMATELY20 MINS AFTER INITIATING THERAPY, THEY RECEIVED 4 POSSIBLE HE LOSS 2 ALARMS. THE PROVIDER IS WONDERING IF THEY SHOULD REPLACE THE IAB. THE IABP IS CURRENTLY PAUSED AND PT IS STABLE. [USER] CONFIRMED THERE WAS NO BLOOD IN DRIVELINE, IAB POSITION LOOKS GOOD ON FLUOROSCOPY, BALLOON IS UNWRAPPED FULLY, AND CONNECTIONS ARE TIGHT. WE DISCUSSED OTHER CAUSES FOR THIS ALARM. THE PHYSICIAN OPTED TO REPLACE THE IAB AT THIS TIME. HE REQUESTED TO CONNECT ON FACETIME FOR CASE SUPPORT. I AGREED. UPON CONNECTION, IAB AND SHEATH REMOVED VIA GUIDEWIRE. ANOTHER 30 CC LWS IAB WAS REPLACED USING THE R FEM. AFTER PLACEMENT, WE DISCUSSED OCCLUSIVITY OF IAB. THE PP WAS 148 AND AUG WAS 106. PHYSICIAN AGREEABLE TO REDUCE VOLUME TO 26 CC". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096398 ↗
• MalfunctionJan 7, 2026Inflation Problem

  IT WAS REPORTED " DIFFICULTY UNWRAPPING AT THE DISTAL TIP AND WAS RESOLVED WITH MANUAL INFLATION. IABP THERAPY DISCONTINUED WITHIN 15MIN DUE TO ONGOING PATIENT HYPERTENSION WITH SYSTOLICS IN 180S-200S. NO ISSUES WITH REMOVAL REPORTED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991626 ↗
• MalfunctionJan 7, 2026Inflation Problem

  IT WAS REPORTED "DISTAL TIP FAILED TO UNWRAP". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND 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 23991324 ↗
• MalfunctionDec 29, 2025Defective Device; Defective Device

  IT WAS REPORTED " PER THE BPW ASSESSMENT, IAB APPEARED TO BE MINIMALLY INFLATING WITH SIGNIFICANT KINK NOTED. MOST RECENT CXR ~10 HOURS PRIOR. RECOMMENDED A STAT CXR TO CONFIRM IAB PLACEMENT. MADE THE RECOMMENDATION TO HYPEREXTEND THE PATIENT'S HIP TO SEE IF THERE WAS ANY IMPROVEMENT TO THE BPW MORPHOLOGY...BPW SHOWS MODERATE KINK WITH SLOW RETURN TO BASELINE. ". ADDITIONAL INFORMATION STATES THAT THE IABP CONSOLE WAS SWAPPED TO CONTINUE THERAPY AND THE IAB VOLUME WAS DECREASED TO CONTINUE THERAPY. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDR#: 3010532612-2025-01290, 3010532612-2025-01296.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909118 ↗
• MalfunctionDec 5, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "POSSIBLE HELIUM LOSS 3 ALARMS; IAB VOLUME SET TO 10CCS (33%)". ADDITIONAL INFORMATION STAES THAT THE IAB CATHETER WAS REMOVED AND NO 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 23728331 ↗
• MalfunctionNov 5, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "HELIUM 2 LOSS ALARM ON IABP. SWITCHED THE CONSOLE ON AND OFF AGAIN AND STILL WOULDN'T WORK. IT WASN'T RUPTURED AS WE REMOVED IT AND INFLATED IT MANUALLY TO CHECK FOR LEAKS. THIS HAPPENED ONCE WE HAD PLACED IT IN THE PATIENT BUT UNFORTUNATELY DUE TO THE ALARM, THE SURGEON REMOVED THE CATHETER AND DIDN'T WANT TO REPLACE IT". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475833 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "CATHETER DID NOT WORK, ENDED UP INSERTING ANOTHER CATHETER THAT WORKED FINE. THEY WERE GETTING HIGH PRESSURE ALARMS WITH THE FIRST. CHECKED CONNECTIONS AND DID NOT SEE ANY KINKS IN THE TUBING". 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 23414700 ↗
• MalfunctionOct 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED " IAB RUPTURE". ADDITIONAL INFORMAITON STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED DUE TO MD DISCRETION. 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 23413024 ↗
• MalfunctionAug 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "LEAKING SHEATH AND BALLOON WOULDN'T GO THROUGH". IT IS UNKNOWN FROM THE CUSTOMER AS HOW THIS ISSUE WAS RESOLVED. THE PATIENT'S CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 22700424 ↗
• MalfunctionJul 25, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "HELIUM LEAK, WOULD NOT HOLD GAS". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND 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 22609147 ↗
• MalfunctionJul 14, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "CLOTTED CATHETER" ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. 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 22493234 ↗
• MalfunctionJul 9, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT "CONCERN FOR CLOTS AFTER NOT MOVING FOR 30MIN. [NURSE] CALLED TO TROUBLESHOOT ALARMS ON GETINGE IABP. THEY HAD EXCHANGED THE CONSOLE PRIOR TO CALL AND GETINGE RECOMMENDED CALLING TELEFLEX D/T THINKING ALARMS WERE IAB RELATED. ON THE ALTERNATE GETINGE CONSOLE, ALARMS PERSISTED. PATIENT STILL AND FLAT. NO BLOOD IN THE DRIVELINE AND CONNECTIONS TIGHT. ALARMS ISSUED WITHIN 5S OF ATTEMPTS TO RESTART THE CONSOLE. [NURSE] TO REPORT THAT HAD NOT BEEN ABLE TO GET THE GETINGE PUMP STARTED AND THE MD OPTED TO DISCONTINUE THE IAB DUE TO THE RISK OF CLOT FORMATION ON THE MEMBRANE. PATIENT REMAINED STABLE AND NO ISSUES REPORTED WITH REMOVAL." NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462144 ↗
• MalfunctionJun 2, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "PERSISTENT POSSIBLE HELIUM LOSS 2 ALARMS. THEY ARE COMING EVERY 2-3 MIN". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND 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 22126387 ↗
• MalfunctionMay 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "IAB RUPTURE". WHAT WAS DONE AFTER THE NOTICE OF THE RUPTURE TO CONTINUE THERAPY IS UNKNOWN. 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 22090873 ↗
• MalfunctionMay 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "SUSPECTED IAB FAILURE". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. THE SECOND IAB CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055986 ↗
• MalfunctionApr 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "SUSPECTED FAILED IAB MEMBRANE". THE IAB CATHETER WAS REMOVED. ADDITIONAL INFORMATION STATES "PATIENT WAS ALSO ON ECMO. MD OPTED NOT TO INSERT ANOTHER." 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 21934353 ↗
• InjuryApr 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "30CC BALLOON RUPTURE. BLOOD WAS VISIBLE IN THE HELIUM DRIVE-LINE TUBING". THE IAB CATHETER WAS REMOVED AND REPLACED. THE SECOND CATHETER WAS INSERTED INTO A DIFFERENT INSERTION SITE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200634. One submission often covers many models, so check the product and lot details in each record.

• Z-1878-2024 · Apr 29, 2024 · Open, Classified
  Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS