ARROW IPN038077Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801902136732), received between Mar 2, 2023 and Aug 2, 2023 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT, "DURING THE PASSAGE OF THE CATHETER IT DID NOT PROGRESS IN THE INTRODUCER, ANOTHER UNSUCCESSFUL ATTEMPT WAS MADE AND AFTER IT WAS DECIDED TO INTERRUPT THE PROCEDURE." THE HOSPITAL DID NOT HAVE A 2ND CATHETER TO ATTEMPT ANOTHER INSERTION. THE PROCEDURES BEING PERFORMED IN CONJUNCTION WITH THE IAB INSERTION WERE A PRIMARY ANGIOPLASTY AND ARTERIAL RECANALIZATION DUE TO AN ACUTE MYOCARDIAL INFARCTION. ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT EXPIRED TWO HOURS AFTER THE ISSUE OCCURRED. THE CAUSE OF DEATH IS REPORTED AS SEVERE VENTRICULAR FAILURE AND CARDIOGENIC SHOCK SECONDARY TO ACUTE MYOCARDIAL INFARCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444249 ↗
• InjuryJul 14, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "AN ATTEMPT WAS MADE TO ADVANCE A GUIDE AND PLACE A 40 CC INTRA-AORTIC COUNTER PULSATION BALLOON. HOWEVER, THE BALLOON DID NOT ADVANCE BEYOND THE AORTOILIAC BIFURCATION DESPITE MULTIPLE ATTEMPTS. UPON BALLOON REMOVAL, IT WAS OBSERVED THAT THE GUIDE WAS ADHERED TO IT, WHICH HINDERED ITS DISPLACEMENT. FOR THIS REASON, BOTH THE BALLOON AND THE GUIDE WERE REMOVED. DURING THE EXTRACTION, A DEFORMITY IN THE INTRODUCER WAS NOTICED, SO IT WAS ALSO REMOVED. COMPRESSION WITH FEMOSTOP WAS APPLIED TO THE RIGHT FEMORAL ARTERY, AND A COMPRESSIVE DRESSING WAS APPLIED USING GAUZE AND ADHESIVE TAPE. THE PATIENT WAS EXPLAINED THE REASONS FOR ABORTING THE PROCEDURE, AND THE CARDIOVASCULAR SURGERY TEAM WAS INFORMED. AT THAT TIME, THE PATIENT HAD NO BLEEDING OR HEMATOMA. HOWEVER, AFTER 20 MINUTES, THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM, WHERE PERIPHERAL VASCULAR REPAIR WAS PERFORMED DUE TO THE PRESENCE OF AN EXPANDING HEMATOMA AT THE PUNCTURE SITE. ADDITIONALLY, A RETROPERITONEAL HEMATOMA ASSOCIATED WITH THE EVENT WAS IDENTIFIED, WHICH REQUIRED SURGICAL INTERVENTION". ADDITIONAL INFORMATION STATES "THE PATIENT WAS NOT IN CRITICAL CONDITION, BUT REQUIRED PREOPERATIVE CARD

  Patient problems: Exsanguination; Hematoma

  MAUDE report 17325345 ↗
• MalfunctionJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT "DURING THE INSERTION PROCESS, THE SHEATH WAS FOUND RUPTURED". ADDITIONAL INFORMATION RECEIVED STATES THAT THE "RUPTURE" WAS FOUND ON THE TIP OF THE SHEATH. AS A RESULT, A NEW 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 17255241 ↗
• InjuryMay 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE CATHETER RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT A DIFFERENT INSERTION SITE. NO PATIENT HARM OR INJURY. THE CURRENT STATUS OF THE PATIENT IS "IMPROVING SLOWLY, HAS HAD BYPASS SURGERY AND WEANED OFF THE 2ND IABP".

  Patient problems: Needle Stick/Puncture

  MAUDE report 16953708 ↗
• MalfunctionMay 9, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE IAB CATHETER WAS DIFFICULT TO INSERT. 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 16898839 ↗
• InjuryApr 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD WAS NOTED IN THE DRIVELINE TUBING, THE IAB RUPTURED. AS A RESULT, THE IAB WAS SURGICALLY 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: Needle Stick/Puncture

  MAUDE report 16829758 ↗
• MalfunctionApr 20, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE CATHETER WAS INSERTED, THE PUMP ALARMED FOR "POSSIBLE HELIUM LEAK" AFTER ABOUT 2 MINUTES. CATHETER POSITION WAS CONFIRMED AND THE BALLOON INFLATION RATE WAS DECREASED TO 35CC. THE ALARM PERSISTED. THE TRIGGERING MODE WAS IN NORMAL SINUS RHYTHM WITH A HR OF 82. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THERAPY THEN CONTINUED NORMALLY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777232 ↗
• MalfunctionApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE CATHETER WAS INSERTED, THE PUMP ALARMED FOR "HELIUM LOSS". IT WAS FOUND THAT THERE WAS BLOOD IN THE CATHETER AND THE CATHETER HAD RUPTURED. AS A RESULT, A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE AND THERAPY WAS CONTINUED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS US REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728344 ↗
• MalfunctionApr 3, 2023Leak/Splash; Leak/Splash

  THE REPORT STATES, WHILE IN USE ON A PATIENT THERE WAS A "REPORTED RUPTURE IAB". NO FURTHER INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER TO INQUIRE IF MEDICAL INTERVENTION WAS REQUIRED, HOW THE ISSUE WAS RESOLVED, AND WHAT THE PATIENT'S CURRENT HEALTH CONDITION IS. THE CUSTOMER DID NOT RESPOND. IF ADDITIONAL INFORMATION IS RECEIVED, THIS COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16663417 ↗
• MalfunctionMar 31, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING INSERTION, TWO CATHETERS CONSECUTIVELY WOULD NOT FIT THROUGH THE SHEATH. AS A RESULT, A THIRD CATHETER WAS USED AND WAS SUCCESSFUL. ALL CATHETERS WERE INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR 3010532612-2023-00195.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659542 ↗
• MalfunctionMar 31, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING INSERTION, TWO CATHETERS CONSECUTIVELY WOULD NOT FIT THROUGH THE SHEATH. AS A RESULT, A THIRD CATHETER WAS USED AND WAS SUCCESSFUL. ALL CATHETERS WERE INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDR 3010532612-2023-00196.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659526 ↗
• MalfunctionMar 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT "24 HOURS AFTER THE POSITIONING OF THE DEVICE, THERE WAS AN APPEARANCE OF PEDIDIUM PULSE HYPOSPHYGMIC ON THE RIGHT (IABP ACCESS SITE): AT THE DOPPLER CONTROL FLOWS PRESENT. REMOVAL OF IABP ON 14.02 FOR CLINICAL STABILIZATION". THE CATHETER WAS NOT REPLACED. ATTEMPTS WERE MADE TO INQUIRE WHETHER MEDICAL INTERVENTION WAS REQUIRED, IF THERE WAS ANY HARM OR INJURY TO THE PATIENT, AND THE STATUS OF THE PATIENT. THE CUSTOMER WAS UNABLE TO ANSWER THESE QUESTIONS. IF ADDITIONAL INFORMATION IS RECEIVED ON THIS COMPLAINT, THE FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 16619002 ↗
• MalfunctionMar 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, "HIGHLY TORTUROUS FEMORAL ARTERY, THE SHEATH AND THE SHAFT OF IABP WAS KINKED AND THE BALLOON WAS NOT INFLATING, BALLOON WAS REMOVED AS BP WAS NOT DISPLAYED". ADDITIONAL INFORMATION STATES THAT A 2ND IAB WAS USED AND INSERTED AT THE SAME INSERTION SITE. NO HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467192 ↗

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