ARROW IPN001009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902085283), received between Jan 29, 2020 and Sep 1, 2023 — classified as 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K945229); 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.

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.

• MalfunctionSep 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT "THE DIAPHRAGM PRESENT AT THE PROXIMAL END OF THE CORDIS THAT PREVENTS BLEED BACK AFTER TVP INSERTION WAS FAULTY RESULTING IN SIGNIFICANT CONSTANT BLEEDING. AS THERE WAS NO UNDERLYING RHYTHM DECISION WAS MADE TO BANDAGE THE PROXIMAL END AS REMOVING THE TVP AND REPLACING THE SHEATH WOULD HAVE BEEN EXTREMELY RISKY AS THERE WAS NO UNDERLYING RHYTHM. THE DISTAL LOCKING MECHANISM OF THE SHEATH TO THE TVP , THE ONE NEAR THE CORDIS WAS FAULTY AND NOT WORKING AND THE TVP WASN'T BEING LOCKED". ADDITIONAL INFORMATION RECEIVED STATED THAT "THERE WAS BLEEDING INTO THE CATH GUARD". THE BLEEDING TOTALED "80-100CC, NO TRANSFUSION NEEDED". THE CATH GUARD WAS IN THE PATIENT FOR "AROUND 24 HOURS", THE ISSUE WAS RESOLVED BY PUTTING "TIGHT TEGADERMS IN TO STOP THE BLEEDING INSIDE AND THE WIRE WAS SUTURED TO THE PATIENT TO PREVENT IT FROM MOVING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669639 ↗
• MalfunctionJan 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE PHYSICIAN THAT IN THE CARDIAC INTENSIVE CARE UNIT (CICU) A PATIENT WHO ALREADY HAD A CENTRAL LINE, NEEDED PACING DUE TO HER CRASHING PRESSURES. THE PHYSICIAN CONNECTED EVERYTHING AND WHEN THE SYRINGE WAS CONNECTED THERE WAS IMMEDIATE LEAKING. THE SOUND OF AIR COMING IN AROUND FROM WHERE THE SHEATH LOCKS. THE PHYSICIAN NOTICED THAT WHEN HE PULLED BACK ON THE CATHETER FROM THE SHEATH SLIGHTLY THE LEAKING AND AIR COMING IN STOPPED. ADDITIONALLY, THE END OF THE SHEATH WAS KINKED AND THAT ALSO CAUSED THE LEAKING TO STOP. THIS WAS DONE PRIOR TO INSERTING THE CATHETER IN THE PATIENT. THE MD USED ANOTHER CATHETER FROM THE SAME LOT. THE MD REPORTED HAVING THE SAME ISSUE. THE MD RIGGED THE CATHETER WHERE IT WOULD NOT LEAK AND THE PATIENT WAS SUCCESSFULLY PACED. THERE WAS A DELAY IN THERAPY REPORTED THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642939 ↗
• MalfunctionJan 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE PHYSICIAN THAT IN THE CARDIAC INTENSIVE CARE UNIT (CICU) A PATIENT WHO ALREADY HAD A CENTRAL LINE, NEEDED PACING DUE TO HER CRASHING PRESSURES. THE PHYSICIAN CONNECTED EVERYTHING AND WHEN THE SYRINGE WAS CONNECTED THERE WAS IMMEDIATE LEAKING. THE SOUND OF AIR COMING IN AROUND FROM WHERE THE SHEATH LOCKS. THE PHYSICIAN NOTICED THAT WHEN HE PULLED BACK ON THE CATHETER FROM THE SHEATH SLIGHTLY THE LEAKING AND AIR COMING IN STOPPED. ADDITIONALLY, THE END OF THE SHEATH WAS KINKED AND THAT ALSO CAUSED THE LEAKING TO STOP. THIS WAS DONE PRIOR TO INSERTING THE CATHETER IN THE PATIENT. THE MD USED ANOTHER CATHETER FROM THE SAME LOT. THERE WAS A DELAY IN THERAPY REPORTED. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9642685 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945229. One submission often covers many models, so check the product and lot details in each record.

• Z-3197-2018 · Jul 30, 2018 · Terminated
  ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in elec