ARROW IPN000096 (REF AI-07155-KS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801902004536), received between Oct 9, 2018 and Jan 17, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED BY THE CUSTOMER THAT DURING USE ON A PATIENT, "ONE OF THE PINS THAT COMES WITH THE KIT WOULD NOT FIT." AS A RESULT, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION, PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183966 ↗
• MalfunctionMay 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CATH KIT WAS DEFECTIVE, AND THE BALLOON DID NOT INFLATE DURING USE ON A PATIENT. AS A RESULT, A NEW CATHETER WAS USED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454752 ↗
• MalfunctionAug 18, 2021Packaging Problem; Packaging Problem

  THERE WAS NO PATIENT INVOLVEMENT. COMPLAINT WAS REPORTED VIA EMAIL THAT ONE OF THE CARDIOLOGY FELLOWS SUSTAINED A PUNCTURE FROM SCALPEL #11 THAT IS PROVIDED IN THE TEMPORARY PACING CATHETER WITH SHROUDED PINS/INTRODUCER KIT. DR. CHEN EXPLAINED THAT MOST KITS CONTAIN A SPONGE THAT IS USED TO PLACE SHARPS DURING EMERGENT PROCEDURES. THIS SPONGE SERVES AS A TEMPORARY SHARP'S DISPOSAL. THIS PARTICULAR KIT DOES NOT INCLUDE THIS ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338213 ↗
• MalfunctionMar 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE TEMPORARY PACING CATHETER WAS PLACED THROUGH THE CENTRAL LINE, THE STAFF NOTED THAT THEY WERE UNABLE TO FLUSH THE IV PORT AND THE SOLUTION WAS RUNNING UP INTO THE PLASTIC SLEEVE AND WAS UNABLE TO USE THE IV PORT ON THE CENTRAL LINE. THE USER MENTIONED THAT THERE IS A SMALL BIOPATCH TYPE DEVICE THAT SEEMS TO CREATE A SEAL WHICH IS NOT THERE OCCASIONALLY (DROPPED). THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11565006 ↗
• MalfunctionMar 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE TEMPORARY PACING CATHETER WAS PLACED, THE STAFF NOTED THERE WAS OOZING AROUND THE ENTRY PORT INTO THE STERILE PLASTIC SLEEVE. IT WAS NOTED THAT THERE WAS A SLOW ENOUGH LEAK THAT THE ISSUE WAS NOT RESOLVED. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564191 ↗
• MalfunctionMar 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED VIA A USER FACILITY REPORT. WHEN THE TEMPORARY PACING CATHETER WAS USED TO PLACE A TRANSVENOUS PACER IN THE PATIENT. THE BALLOON CATHETER TESTED OUTSIDE OF PATIENT PRIOR TO INSERTION. THE CATHETER WAS INSERTED AND INFLATED, THE STAFF WAS UNABLE TO GET A CAPTURE, SO THE BALLOON WAS DEFLATED. THE NURSE THEN NOTED BLOOD RETURN FROM THE BALLOON PORT, AND THE CATHETER WAS REMOVED FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT THERE WAS NO LONGER A BALLOON ATTACHED TO THE CATHETER. THE BALLOON NEVER APPEARED ON ANY SUBSEQUENT IMAGING OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED BY THE RISK MANAGER. IT COULD NOT BE DETERMINED IF THE BALLOON WAS RUPTURED OR DETACHED. THE RISK MANAGER DID CONFIRM THAT THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT FROM THE BALLOON RUPTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414392 ↗
• MalfunctionOct 9, 2018Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED BY THE RN THAT A TEMPORARY PACEMAKER WAS INSERTED IN A PATIENT. THE TEMPORARY PACER WIRE WAS MOVED BY THE DOCTOR TO 51CM AND A CHEST X-RAY WAS ORDERED TO CONFIRM IT WAS AT THE RIGHT SITE. THE RESULTS OF THE CHEST X-RAY SHOWED THAT THE PACER WAS MOVED TOO FAR IN. THE DOCTOR CAME TO MOVE IT AGAIN BUT BEFORE SHE MOVED IT , IT WAS NOTICED THAT THERE WAS BLOOD RETURN FROM THE BALLOON SITE. THEREFORE THE TEMPORARY PACER WAS REMOVED. THERE WAS NO PATIENT DEATH OR SERIOUS INJURY OR REPORTED. PATIENT CURRENT CONDITION REPORTED AS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948476 ↗

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