ARROW IPN000261Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902010803), received between Aug 3, 2018 and Oct 14, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K010330); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED "POSSIBLE IAB RUPTURE". ADDITIONAL INFORMATION STATES "POSSIBLE HELIUM LOSS 3(2) ALARMS X 7 WITHIN A FEW MINUTES. NO BLOOD VISIBLE IN TUBING, CONNECTIONS TIGHT. ALARM PERSISTED AFTER REPOSITIONING THE PATIENT". 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440391 ↗
• MalfunctionOct 27, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE STAFF ADVANCED THE SHEATH, IT BEGAN TO "FOLD UP ON ITSELF." THE STAFF REMOVED THAT SHEATH AND PLACED A 9 FR SHEATH. WHEN THEY TRIED TO ADVANCE THE BALLOON THROUGH THE 9 FR SHEATH, IT WOULD NOT ADVANCE DUE TO THE BALLOON "BUNCHING UP." AS A RESULT, A SECOND IAB WAS USED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705815 ↗
• MalfunctionOct 27, 2021Unraveled Material; Unraveled Material

  IT WAS REPORTED, THAT WHEN THE STAFF ADVANCED THE SHEATH, IT BEGAN TO "FOLD UP ON ITSELF". THE STAFF REMOVED THAT SHEATH. AND PLACED A 9 FR SHEATH. WHEN THEY TRIED TO ADVANCE THE BALLOON THROUGH THE 9 FR SHEATH, IT WOULD NOT ADVANCE, DUE TO THE BALLOON "BUNCHING UP". AS A RESULT, A SECOND IAB WAS USED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705725 ↗
• MalfunctionApr 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE PATIENT IN THE CATH LAB FOR HEMODYNAMICALLY UNSTABLE STEMI, PREOP. OPEN HEART SURGERY (OHS) WAS PERFORMED ON THE PATIENT AND RETURNED TO OPERATING ROOM (OR). WHEN THE PATIENT WAS RETURNED TO THE UNIT AND THE IAB PLACEMENT WAS NOTED AS LOW ON CXR. THE DR. REPOSITIONED THE IAB AT BEDSIDE AND ALARMS OCCURRED AND BLOOD WAS NOTED. AS A RESULT, THE IAB WAS SUCCESSFULLY REMOVED AT BEDSIDE WITHOUT INCIDENT. THE PATIENT REMAINED STABLE POST REMOVAL, ANOTHER OTHER IAB WAS INSERTED, THERAPY WAS DISCONTINUED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757305 ↗
• MalfunctionFeb 4, 2020Signal Artifact/Noise; Image Display Error/Artifact; Signal Artifact/Noise; Image Display Error/Artifact

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) CATHETER HAD TOO MUCH WHIP WHICH CREATED TOO MUCH ARTIFACT. AS A RESULT, THE USER SWITCHED TO OUR 40CC CATHETER AND IT WORKED FINE. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9664871 ↗
• MalfunctionAug 3, 2018Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THE DOCTOR NOTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS "CORK SCREWING ON ITSELF" AND APPEAR TO BE "SPIRALING OR COILING INSIDE THE CATHETER SHAFT". THE MOVEMENT CAUSE THE CATHETER PLACEMENT TO "MOVE BACKWARDS 4-5 INCHES". THE DOCTOR REPOSITIONED THE CATHETER TWO OR THREE TIMES. AS A RESULT, THE DOCTOR REMOVED AND REPLACED THE CATHETER WITH ANOTHER IAB. THERE WAS NO REPORT OF PATIENT COMPLICATION OR SERIOUS INJURY AND DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747044 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010330. One submission often covers many models, so check the product and lot details in each record.

• Z-1212-2009 · Feb 2, 2009 · Terminated
  8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the a
• Z-1220-2009 · Feb 2, 2009 · Terminated
  9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the
• Z-1211-2009 · Feb 2, 2009 · Terminated
  8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter
• Z-1213-2009 · Feb 2, 2009 · Terminated
  8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the a
• Z-1222-2009 · Feb 2, 2009 · Terminated
  ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation
• Z-1217-2009 · Feb 2, 2009 · Terminated
  8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in
• Z-1218-2009 · Feb 2, 2009 · Terminated
  7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the a
• Z-1215-2009 · Feb 2, 2009 · Terminated
  7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in t
• Z-1210-2009 · Feb 2, 2009 · Terminated
  8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counte
• Z-1221-2009 · Feb 2, 2009 · Terminated
  ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation
• Z-1214-2009 · Feb 2, 2009 · Terminated
  7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in
• Z-1216-2009 · Feb 2, 2009 · Terminated
  8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in
• Z-1219-2009 · Feb 2, 2009 · Terminated
  8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the a