ARROW IPN929209Recalls & reported problems
Teleflex Incorporated · FiberOptix(TM) IAB · Class 2
Quick summary
This Teleflex Arrow FiberOptix intra-aortic balloon is a balloon placed in the aorta to support the heart, used with a control console. Many of the 112 reports describe leaks, false alarms, and inflation problems, and some describe a balloon rupture, a cracked connector, or a kinked helium line. The reports include 3 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 121
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10801902218916), received between Feb 7, 2025 and Sep 29, 2026 — classified as 3 injuries, 118 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (25 reports).
1 other recall cover devices cleared under the same FDA submission (K200634); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash25
- Device Alarm System21
- Fluid/Blood Leak15
- Inflation Problem14
- Material Integrity Problem9
- Connection Problem7
- Material Rupture6
- Patient Device Interaction Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions95
- Insufficient Information26
Recent adverse event reports
The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933054 ↗MalfunctionSep 17, 2026Gas/Air Leak
Patient problems: Insufficient Information
MAUDE report 50809915 ↗MalfunctionAug 31, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531192 ↗MalfunctionAug 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531114 ↗MalfunctionAug 24, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410590 ↗MalfunctionAug 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50409956 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50286957 ↗MalfunctionAug 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202451 ↗MalfunctionAug 10, 2026Fluid/Blood Leak
It was reported that threads stripped on actis extraction tip.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50198184 ↗MalfunctionAug 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194695 ↗MalfunctionAug 10, 2026Device Handling Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194638 ↗MalfunctionAug 3, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50118642 ↗MalfunctionMay 18, 2026Material Twisted/Bent
IT WAS REPORTED THAT "CALLER REPORTS POSSIBLE HE LOSS 3 AND HIGH BASELINE ALARMS. HELIUM DRIVELINE FOUND TO BE SEVERELY KINKED. CALLER HAS RETRIEVED ANOTHER HELIUM DRIVELINE. HELIUM DRIVELINE EXCHANGED SUCCESSFULLY. HE ALARMS RESOLVED AFTER EXCHANGE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25206072 ↗MalfunctionApr 23, 2026Fluid/Blood Leak
IT WAS REPORTED THAT BLOOD WAS DISCOVERED IN THE HELIUM DRIVELINE. AS A RESULT THE IAB WAS REMOVED. IAB WAS NOT REPLACED. NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971641 ↗MalfunctionApr 22, 2026Material Rupture
REPORTED AS "BALLOON RUPTURE". AS A RESULT, THE IAB WAS REMOVED. THE IAB WAS NOT REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956680 ↗MalfunctionApr 22, 2026Leak/Splash
REPORTED AS "POTENTIAL IAB RUPTURE". THE REPORT FURTHER STATES, "[USER] IS CALLING FROM THE CCL. THEY HAVE JUST PLACED A 40 CC LWS AND ARE GETTING POSSIBLE HE LOSS 2 ALARMS. THEY HAVE RECEIVED 5 TOTAL AND THEY ARE COMING APPROXIMATELY EVERY 2 MINS. HE IS REQUESTING ASSISTANCE. [USER] CONFIRMED THERE WAS NO BLOOD IN DRIVELINE, NO VISIBLE KINKING, AND CONNECTIONS WERE TIGHT. CCL TEAM OPTING TO REPLACE IAB. MD REMOVED IAB AND SHEATH OVER WIRE PRESERVING THE L FEM ACCESS FOR NEW 40 CC IAB REPLACEMENT. IAB REPLACED AND IABP THERAPY STARTED WITHOUT ALARMS". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955379 ↗MalfunctionApr 20, 2026Crack; Disconnection
IT WAS REPORTED THAT "LUER LOCK CONNECTOR CRACKED AND TUBING DISCONNECTED - CRACKED CONNECTOR SEQUESTERED; AFTER TURN, RN NOTICED BALLOON HAD PULLED OUT FURTHER FROM THE PROTECTIVE COVERING". ADDITIONAL INFORMATION RECEIVED STATES THAT, "THE ACCOUNT IS NOT SHARING ANY ADDITIONAL INFORMATION OTHER THAN WHAT WAS PROVIDED".
Patient problems: Insufficient Information
MAUDE report 24927627 ↗MalfunctionApr 20, 2026Material Rupture
IT WAS REPORTED THAT THERE WAS A BALLOON RUPTURE. THE INFORMATION FURTHER STATES, "I SPOKE WITH THE CLINICAL ICU EDUCATOR WHO LET ME KNOW THAT THE PATIENT WAS KNOWN TO HAVE TORTUOUS ANATOMY WHICH MAY HAVE CONTRIBUTED TO THE RUPTURE. BALLOON REMOVED, PER ACCOUNT THERE MAY HAVE BEEN A DELAY IN BALLOON REMOVAL. UNKNOWN AT THIS TIME HOW MUCH OF A DELAY". NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926440 ↗MalfunctionApr 13, 2026Material Integrity Problem
IT WAS REPORTED "BALLOON FAILED TO UNWRAP". ADDITIONAL INFOMORMATION STATES THAT THE BALLOON CATHETER "EVENTUALLY UNWRAPPED". THE IAB CATHETER WAS NOT REMOVED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".
Patient problems: Insufficient Information
MAUDE report 24860176 ↗MalfunctionApr 9, 2026Inflation Problem
IT WAS REPORTED "BALLOON DID NOT UNWRAP COMPLETELY AND NEEDED TO BE REPLACED". ADDITIONAL INFORMATION STATES THAT MANUAL INFLATION WAS USED TO CONTINUE THERAPY. THE ORIGIONAL CATHETER REMAINED IN PLACE AND WAS ADEQUATE FOR THERAPY. NO PAITNE INJURY OR CONSEQUENCE REPORTED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Insufficient Information
MAUDE report 24829203 ↗MalfunctionApr 8, 2026Inflation Problem
IT WAS REPORTED "BALLOON DID NOT UNWRAP COMPLETELY AND NEEDED TO BE REPLACED". ADDITIONAL INFORMATION STATES THAT LOCATION OF THE SECOND CATHETER USED IS UNKNOWN. 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 24817048 ↗MalfunctionApr 8, 2026Inflation Problem
IT WAS REPORTED "BALLOON [CATHETER]HAVE NOT UNRAVELED COMPLETELY ONCE THEY HAVE BEEN PLACED IN THE BODY". ADDITIONAL INFORMATION STATES THAT MANUAL INFLATION WAS USED AND THE BALLOON INFLATED AND WAS ADEQUATE FOR THERAPY. NO PATIENT INJURY OR COSNEQUENCE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24816855 ↗MalfunctionApr 7, 2026Inflation Problem
IT WAS REPORTED " BALLOON DID NOT INFLATE". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND 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 24800258 ↗MalfunctionApr 6, 2026Material Rupture
IT WAS REPORTED "BLOOD IN HE DRIVELINE, IAB RUPTURE". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788972 ↗MalfunctionApr 1, 2026Device Sensing Problem
IT WAS REPORTED "AP FOS OUT OF RANGE". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR COSNEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755375 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K200634. One submission often covers many models, so check the product and lot details in each record.
- Z-1878-2024 · Apr 29, 2024 · Open, ClassifiedArrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Other System, balloon, intra-aortic and control devices
- CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53Datascope Corp. · System, Balloon, Intra-Aortic And Control21 recalls39 deaths10,316 reports
- CS300 Intra-Aortic Balloon Pump, English, 110V 0998-00-3023-53Datascope Corp. · System, Balloon, Intra-Aortic And Control12 deaths3,164 reports
- CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls8 deaths1,686 reports
- CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls5 deaths1,181 reports
- CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52Datascope Corp. · System, Balloon, Intra-Aortic And Control19 recalls2 deaths1,157 reports
- SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) 0684-00-0576-01Datascope Corp. · System, Balloon, Intra-Aortic And Control2 recalls33 deaths1,541 reports
- CARDIOSAVE RESCUE 0998-00-0800-83Datascope Corp. · System, Balloon, Intra-Aortic And Control26 recalls167 reports
- CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65Datascope Corp. · System, Balloon, Intra-Aortic And Control20 recalls3 deaths456 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.