ARROW IPN915317Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902161892), received between Oct 2, 2022 and Jan 4, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 29, 2024Open, Classified

   Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

   Z-1878-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Connection Problem; Connection Problem

  THE EVENT OCCURRED ON (B)(6) 2022. IT WAS REPORTED THAT PRIOR TO INSERTION DURING CALIBRATION, "IT DID NOT FIT AND THE CALIBRATION DIDN'T HAPPEN". UPON FURTHER COMMUNICATION ON (B)(6) 2022, THE CUSTOMER STATED THAT THE PATIENT HAD EXPIRED. MULTIPLE INQUIRIES SURROUNDING THE EVENT AND DEATH WERE MADE. ON (B)(6) 2023, THE CUSTOMER STATED "THE DEVICE DIDN'T CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. WE WILL NOT ANSWER OTHER QUESTIONS DUE TO THE PROTECTION OF PATIENT AND DOCTOR DATA". IF TELEFLEX RECEIVES ADDITIONAL INFORMATION ON THIS EVENT, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095818 ↗
• MalfunctionJan 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB RUPTURE/ABRASION CATHETER REMOVED". AS REPORTED BY THE CLINICAL SUPPORT SPECIALIST: "EMAILED RECEIVED 27DEC2022 TO REPORT INCIDENT ON (B)(6) 2022 11:20AM. RT CALLED TO CONFIRM BLOOD SPECS IN HELIUM LINE. TUBING CLAMPED AND CALL PLACED TO [PHYSICIAN]. [PHYSICIAN] REMOVED CATHETER AT (B)(6) 2022 AT 1:56 PM. HEMATOMA AT GROIN SITE. NO DIFFICULTY NOTED ON REMOVAL, NO COMPLICATIONS. PATIENT CURRENTLY CRITICAL DUE TO NATURE OF ILLNESS AND COMPLICATED COURSE (NOT DUE TO IAB REMOVAL). NO IAB CATHETER REPLACED. NO BLOOD NOTED IN PUMP OR CONDENSATION TUBING, PUMP SENT TO BIOMED FOR INSPECTION, CATHETER RETAINED FOR RETURN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086865 ↗
• MalfunctionOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS RECEIVED VIA TRANSFER FROM AN OUTSIDE FACILITY, (B)(6), THERE WERE RUSTY COLORED FLECKS OF BLOOD NOTED IN THE GAS LINE AND THE FLECKS ARE ON THE INSIDE OF THE TUBING BUT THERE WERE NO ALARMS. NO ALARM STRIPS WERE PROVIDED. THE IAB WAS REMOVED AND REPLACED IN THE SAME SITE. THERE WERE NO COMPLICATIONS WITH REMOVAL OR REINSERTION. PATIENT IS CURRENTLY STABLE ON THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673590 ↗
• MalfunctionOct 2, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS DEFECTIVE; IT WOULD NOT PUMP/WORK. IT WAS USED AS INDICATED AND THE REPORTED ISSUE OCCURRED RIGHT AT THE FIRST INFLATION OF THE CATHETER. THERE WERE NO ISSUES AT THE INSERTION SITE. THE CATHETER WAS REPLACED WITH A NEW ONE THAT WORKED AS INTENDED. NO PUMP STRIPS WERE GENERATED FOR REVIEW. THERE WAS NO MEDICAL INTERVENTION OR NEGATIVE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526208 ↗