ARROW IPN915324Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10801902161960), received between Dec 1, 2022 and Aug 28, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Image Display Error/Artifact; Inflation Problem; Pumping Stopped

  Access right femoral - no complication.Pump inserted without difficulty.Pumped turned on for about 20 pumps, AO waveform did not look like a typical IABP "[intra-aortic balloon pump]" waveform. Red error "Helium loss" pump stopped. Teleflex hotline called "[redacted]".Hotline had us check all connections and look under fluoro the position of the balloon. We attempted to turn pump back on and the balloons distal tip did not look to be inflating. Manual inflation was the next suggestion from the Hotline. We aspirated on the Helium line (no blood present) and we manually inflated balloon. No difficulty. We saw the balloon under fluoro fully inflate. Turned pump back on and red error "helium loss" still persisted.At that time, we decided to switch balloon out for another 30cc IABP ((b)(6) Lot: 18F25H0103). Second balloon went in without difficulty. Pumped for about 2 minutes but under fluoro did not look to be fully inflated (distal tip not inflating). Pump was paused and a pullback/ manual inflation was performed per hotline.Pump restarted. Under fluoro balloon fully inflated and working properly without alarm.Initial balloon was saved. Manufacturer response for System, balloon, intra

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508445 ↗
• MalfunctionJul 27, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT "THIS PATIENT HAD A NORMAL PUNCTURE, THE CATHETER WAS OPENED AND VACUUMED, THE CATHETER WAS REMOVED FLAT, A LOOSE BALLOON COULD NOT BE IMPLANTED, THE DOCTOR VACUUMED AGAIN, IT IS STILL LOOSE, THE CATHETER COULD NOT BE COMPLETELY WRAPPED AND COULD NOT INTO THE SHEATH, AND SO THE DOCTOR WITHDRAW THE CATHETER THERE WAS A SMALL LOCALIZED HEMATOMA AT THE INSERTION SITE; THE PATIENT CONDITION IS FINE. OTHER TREATMENT WILL BE TAKEN." A 2ND CATHETER WAS NOT INSERTED. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17408220 ↗
• MalfunctionMar 14, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT AFTER THE IAB WAS INSERTED INTO THE PATIENT, THE IABP WAS UNABLE TO DISPLAY THE BLOOD PRESSURE WAVEFORM. ATTEMPTS AT ADJUSTING THE CATHETER POSITION AND FLUSHING THE CENTRAL LUMEN WERE UNSUCCESSFUL. AS A RESULT, A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538741 ↗
• MalfunctionMar 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "AFTER THE OPERATOR PERFORMED CAG+PTCA, THE IABP WAS INSERTED. AFTER THE MACHINE WAS TURNED ON, THE ALARM SHOWED HELIUM LEAKAGE. ACCORDING TO THE ALARM INFORMATION, THE OPERATOR WITHDREW HALF OF THE BALLOON, AND THERE WAS BLOOD GUSHING OUT OF THE BALLOON. THEN THE NEW CATHETER WAS REPLACED, AND THE MACHINE WAS NORMAL." THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16468048 ↗
• MalfunctionFeb 21, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023, BASED ON THE DIAGNOSIS OF 'ACUTE INFERIOR MYOCARDIAL INFARCTION'. ON (B)(6) 2023, THE STENT OPERATION WAS PERFORMED. AFTER THE DOCTOR PUNCTURED THE FEMORAL ARTERY FOR THE PATIENT, THE DOCTOR FELT THAT THE FIRST INTRA-AORTIC BALLOON IMPLANTATION WAS NOT SMOOTH. AFTER THE AORTIC BALLOON IMPLANTATION, THE MACHINE SHOWED THAT IT COULD NOT INFLATE. A NEW SET WAS REPLACED AND THE OPERATION WAS SUCCESSFUL." THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410312 ↗
• MalfunctionFeb 7, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "BALLOON GOT AIR LEAK WHEN USING." AS A RESULT THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312634 ↗
• MalfunctionDec 29, 2022Leak/Splash; Leak/Splash

  IT IS REPORTED THAT A LEAK WAS FOUND ON A CATHETER WHILE IN USE ON A PATIENT. THEREFORE, A SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE REPORT STATES, "THE PATIENT WAS CRITICAL PRIOR TO THE EVENT" AND THAT "THE PATIENT IS IN THE ICU, THE CURRENT CONDITION IS CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074835 ↗
• MalfunctionDec 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "(B)(6) 2022, IN (B)(6) HOSPITAL, THE BALLOON WAS IMPLANTED, AFTER 6 MINUTES, THE BLOOD WAS FOUND IN THE HELIUM TUBE, THE DOCTOR JUDGED THAT THE BALLOON RUPTURED AND IMMEDIATELY ARRANGED TO WITHDRAW THE CATHETER. AFTER THAT, THE MAQUET CATHETER WAS RE-IMPLANTED IN THE SAME SIDE, IT WAS NORMAL". NO MEDICAL INTERVENTION REQUIRED. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034832 ↗
• MalfunctionDec 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE ACCORDING TO IFU, THE PHYSICIAN FOUND THAT THE WIRE WAS BENT AND OPENED UP A NEW KIT TO FINISH THE PROCEDURE. PER THE CUSTOMER, IT IS UNKNOWN IF THE SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE OR A DIFFERENT SITE. THE PATIENT CONDITION IS REPORTED AS "FINE". NO HARM OR INJURY TO THE PATIENT. NO REPORT OF DELAY OF THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896046 ↗

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