ARROW IPN039791Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902145700), received between Jan 13, 2023 and Aug 9, 2023 — classified as 3 malfunctions.

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

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 30CC FIBEROPTIX, IAB-05830-LWS WAS IN PLACE ON THE PATIENT IN THE LEFT AXILLARY SITE, IT RUPTURED ON 6/12. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY, THE PATIENT STATUS IS REPORTED AS "ALERT/ORIENTED WITHOUT COMPLAINTS OR NEUROLOGICAL DEFICITS". SEE ASSOCIATED MDR #3010532612-2023-00378.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17488007 ↗
• MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB ABRASION/RUPTURE". THE REPORT STATES THAT THE IAB WAS INSERTED AT AN OUTSIDE FACILITY. AFTER TRANSFER TO A DIFFERENT FACILITY, BLOOD WAS NOTED IN THE CATHETER TUBING. AS A RESULT, THE IAB WAS REMOVED. A 2ND IAB WAS NOT INSERTED AND THERAPY WAS DISCONTINUED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083412 ↗
• MalfunctionJan 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "BLOOD NOTED IN HELIUM TUBING". AS REPORTED BY THE CLINICAL SUPPORT SPECIALIST: "NURSE NOTED BLOOD IN THE HELIUM TUBING WHEN SHE WAS DOING HER ASSESSMENT. THE PUMP IS PUMPING AND NOT ALARMING. SHE CALLED THE HOT-LINE. I HAD HER STOP PUMPING, CLAMP THE TUBING, AND DISCONNECT THE CATHETER FROM THE PUMP. NEXT SHE CONTACTED THE PHYSICIAN TO COME AND REMOVE THE CATHETER. THIS IS A FEMALE PATIENT WITH A 30 CC FIBEROPTIC IAB. THE CATHETER WAS PLACED YESTERDAY AT ABOUT 1 PM WHILE THE PATIENT WAS IN THE CATH LAB. THE PATIENT HAD A DISSECTED LAD AND MITRAL VALVE REGURG. THEY ARE TRYING TO DECIDE IF THE PATIENT WILL GO FOR A HIGH RISK PTCI OR CABG SURGERY. THE PATIENT IS STABLE". PER THE CUSTOMER IT IS UNKNOWN IF A SECOND CATHETER WAS INSERTED. NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157444 ↗