ARROW IPN000032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902003997), received between Jan 16, 2020 and Jan 16, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K895268); 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 16, 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.

• MalfunctionJan 16, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT "DURING USE ON THE PATIENT THE PHYSICIAN INSERTED THE CATHETER AND WAS ABLE TO MEASURE PRESSURES IN RA (RIGHT ATRIUM), RV (RIGHT VENTRICLE) AND SVC (SUPERIOR VENA CAVA) BUT WAS UNABLE TO REACH THE PULMONARY ARTERY. IT WAS REPORTED THAT A SECOND CATHETER WAS USED AND THERAPY WAS FINISHED SUCCESSFULLY. CLINICAL CONSEQUENCES: THERE WERE NO REPORT OF ANY CLINICAL CONSEQUENCE OR PATIENT COMPLICATIONS. IN THE MEANWHILE THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597534 ↗
• MalfunctionJan 16, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT "DURING USE ON THE PATIENT THE PHYSICIAN INSERTED THE CATHETER AND WAS ABLE TO MEASURE PRESSURES IN RA (RIGHT ATRIUM), RV (RIGHT VENTRICLE) AND SVC (SUPERIOR VENA CAVA) BUT WAS UNABLE TO REACH THE PULMONARY ARTERY. IT WAS REPORTED THAT A SECOND CATHETER WAS USED BUT THE THERAPY WAS NOT FINISHED. CLINICAL CONSEQUENCES: THERE WERE NO REPORT OF ANY CLINICAL CONSEQUENCE OR PATIENT COMPLICATIONS. IN THE MEANWHILE THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597299 ↗
• MalfunctionJan 16, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT "DURING USE ON THE PATIENT THE PHYSICIAN INSERTED THE CATHETER AND WAS ABLE TO MEASURE PRESSURES IN RA (RIGHT ATRIUM), RV (RIGHT VENTRICLE) AND SVC (SUPERIOR VENA CAVA) BUT WAS UNABLE TO REACH THE PULMONARY ARTERY. IT WAS REPORTED THAT A SECOND CATHETER WAS USED BUT THE THERAPY WAS NOT FINISHED. CLINICAL CONSEQUENCES: THERE WERE NO REPORT OF ANY CLINICAL CONSEQUENCE OR PATIENT COMPLICATIONS. IN THE MEANWHILE THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K895268. One submission often covers many models, so check the product and lot details in each record.

• Z-0331-2017 · Sep 2, 2016 · Terminated
  HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/ballo