ARROW IPN929210Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10801902218923), received between Dec 20, 2024 and Sep 21, 2026 — classified as 3 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (19 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842960 ↗
• MalfunctionSep 21, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842833 ↗
• MalfunctionSep 17, 2026Gas/Air Leak

  Patient problems: Insufficient Information

  MAUDE report 50808876 ↗
• MalfunctionSep 14, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763804 ↗
• MalfunctionSep 3, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595625 ↗
• MalfunctionSep 2, 2026Inflation Problem

  Patient problems: Insufficient Information

  MAUDE report 50563908 ↗
• MalfunctionSep 1, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548020 ↗
• MalfunctionAug 21, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374297 ↗
• MalfunctionAug 19, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327336 ↗
• MalfunctionAug 13, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241008 ↗
• MalfunctionAug 12, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223438 ↗
• MalfunctionAug 7, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176611 ↗
• MalfunctionJul 29, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070312 ↗
• MalfunctionJul 29, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070249 ↗
• MalfunctionApr 22, 2026Material Twisted/Bent

  REPORTED AS "SEVERE KINK, POSSIBLE UNWRAPPING ISSUE UNRESOLVED WITH TROUBLESHOOTING". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS PLACED IN 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 24955752 ↗
• MalfunctionApr 21, 2026Inflation Problem

  REPORTED AS "FAILURE TO UNWRAP". THE REPORT FURTHER STATES, "CCL TEAM IS CALLING DUE TO HIGH PRESSURE ALARMS BEING ISSUED AFTER PLACEMENT OF 50 CCLWS IAB IN L FEM. ON FLUOROSCOPY, THE IAB'S DISTAL TIP WAS NOT FULLY UNWRAPPING. I WALKED THE CARDIOLOGIST THROUGH MANUAL INFLATION X2 THAT WAS UNSUCCESSFUL. IT WAS THEN DECIDED TO REMOVE THE IAB. ANOTHER 50 CC LWS IAB PLACED USING SAME INSERTION SITE SUCCESSFULLY AND THERAPY INITIATED. FOS MANUALLY ZEROED DUE TO SAME IABP BEING USED. FOS STATUS: OK". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942353 ↗
• MalfunctionApr 9, 2026Inflation Problem

  IT WAS REPORTED "IAB FAILURE TO UNWRAP". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. 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 24831536 ↗
• MalfunctionApr 2, 2026Difficult to Insert

  IT WAS REPORTED "DIFFICULTY PASSING CATHETER OVER THE GUIDEWIRE. REPLACED THE IAB FOR ANOTHER 50 CC FIBEROPTIC SC IAB. ONCE THE IAB WAS IN PLACE, THEY INITIATED THE THERAPY AND GOT A HIGH PRESSURE ALARM. THEY ALSO HAD DIFFICULTY SEEING THE BALLOON FULLY INFLATE. THEY WATCHED THE IAB FOR A FEW MINUTES AND IT SEEMED TO BE SUPPORTING THE PATIENT, BUT THEY CONTINUED TO GIVE HIGH PRESSURE ALARMS. THEY NOTED THAT THE TIP SEEMED TO BE FULLY INFLATING NOW. THE PATIENT WAS NOT ON ANY VASOPRESSORS. THE PHYSICIAN DECIDED TO REPLACE THE BALLOON USING THE SAME SITE. REPLACED THE BALLOON WITH A SECOND 50 CC FIBEROPTIC SC. THEY WERE ABLE TO GET BALLOON PLACED WITHOUT ANY DIFFICULTY. WHEN THEY INITIATED THERAPY, THEY GOT HIGH PRESSURE ALARMS AGAIN. THE TIP WAS SLOW TO FULLY INFLATE. THE PATIENT WAS GETTING SUPPORT. THEY DECIDED TO REDUCE THE BALLOON VOLUME TO 40 CC. THERE WERE NO FURTHER ALARMS". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDR#'S: 3010532612-2026-00382, 3010532612-2026-00274 & 3010532612-2026-00381.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764700 ↗
• MalfunctionApr 1, 2026Inflation Problem

  IT WAS REPORTED "DIFFICULTY PASSING CATHETER OVER THE GUIDEWIRE. REPLACED THE IAB FOR ANOTHER 50 CC FIBEROPTIC SC IAB. ONCE THE IAB WAS IN PLACE, THEY INITIATED THE THERAPY AND GOT A HIGH-PRESSURE ALARM. THEY ALSO HAD DIFFICULTY SEEING THE BALLOON FULLY INFLATE. THEY WATCHED THE IAB FOR A FEW MINUTES AND IT SEEMED TO BE SUPPORTING THE PATIENT, BUT THEY CONTINUED TO GIVE HIGH PRESSURE ALARMS. THEY NOTED THAT THE TIP SEEMED TO BE FULLY INFLATING NOW. THE PATIENT WAS NOT ON ANY VASOPRESSORS. THE PHYSICIAN DECIDED TO REPLACE THE BALLOON USING THE SAME SITE. REPLACED THE BALLOON WITH A SECOND 50 CC FIBEROPTIC SC. THEY WERE ABLE TO GET BALLOON PLACED WITHOUT ANY DIFFICULTY. WHEN THEY INITIATED THERAPY, THEY GOT HIGH PRESSURE ALARMS AGAIN. THE TIP WAS SLOW TO FULLY INFLATE. THE PATIENT WAS GETTING SUPPORT. THEY DECIDED TO REDUCE THE BALLOON VOLUME TO 40 CC. THERE WERE NO FURTHER ALARMS". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDR#'S: 3010532612-2026-00274 & 3010532612-2026-00381.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752914 ↗
• MalfunctionMar 30, 2026Delivered as Unsterile Product

  IT WAS REPORTED "FOREIGN BODY IN DRIVELINE. SMALL PIECE OF CLEAR PLASTIC IN THE DRIVELINE. ADVISED TEAM TO TEMPORARILY PAUSE PUMP REMOVE DRIVELINE FROM PUMP AND PULL ADAPTER OFF TO CLEAR THE DRIVELINE OF THE FOREIGN OBJECT. [PHYSICAN] DECLINED STATING THE CCL TEAM WOULD BE COMING IN TO REPLACE THE DRIVELINE WITH A DRIVELINE FROM A NEW KIT". 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 24712938 ↗
• MalfunctionMar 25, 2026Material Integrity Problem

  IT WAS REPORTED "BALLON DID NOT INFLATE". 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: Insufficient Information

  MAUDE report 24687130 ↗
• MalfunctionMar 25, 2026Material Integrity Problem

  IT WAS REPORTED "BALLOON FAILED TO INFLATE. MANUAL INFLATION PREFORMED, BALLOON STILL DID NOT FULLY INFLATE". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION 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: Insufficient Information

  MAUDE report 24687109 ↗
• MalfunctionMar 17, 2026Inflation Problem

  IT WAS REPORTED "BALLOON FAILED TO EXPAND IN AORTA". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED THAT PATIENT'S CURRENT CONTITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616352 ↗
• MalfunctionMar 13, 2026Material Twisted/Bent

  IT WAS REPORTED "IAB REMOVED DUE TO SEVERE KINKING". ADDITIONAL INFORMATION STATES THAT THE IAB WAS EXCHANGED OVER THE GUIDEWIRE. 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 24597896 ↗
• MalfunctionFeb 27, 2026Material Integrity Problem

  IT WAS REPORTED "SUSPECTED ABRASION, IAB FAILED LEAK TEST". ADDITIONAL INFORMATION STATES THAT 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: Insufficient Information

  MAUDE report 24469352 ↗

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