ARROW IPN917287Recalls & reported problems

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902172089), received between Aug 14, 2023 and Aug 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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

Device problems

Battery Problem1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 14, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT "WE HAD AN INCIDENT WITH ONE OF THE BALLOON PUMPS TODAY DURING A PRIMARY AND RESULTED WITH US HAVING TO TRANSFER BALLOON PUMPS. THE PUMP HAS BEEN LEFT ON CHARGE BUT DOES NOT SEEM TO HOLD ANY CHARGE WHEN DISCONNECTED FROM THE MAINS AND THEN THE SCREEN AND PUMP CUT OUT WITHOUT ALARMING." NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS BEFORE AND AFTER THE EVENT IS REPORTED AS "CRITICAL".
Patient problems: Insufficient Information
MAUDE report 17543981 ↗

Device details

UDI-DI	`10801902172089`
Brand	ARROW
Model	IPN917287
Catalog no.	IAP-0600
Company	Teleflex Incorporated
Product code	DSP · System, balloon, intra-aortic and control
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jun 25, 2026

Device type (GMDN): Intra-aortic balloon pump

An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.

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All System, balloon, intra-aortic and control devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.