ARROW IPN056682Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902167719), received between Jan 31, 2022 and Mar 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K122545); 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 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.

• MalfunctionMar 14, 2023Material Separation; Material Separation

  IT WAS REPORTED "HUB SEPARATED FROM EXTENSION LINE FOLLOWING CATHETER FLUSH. INCIDENT OCCURRED WHEN NURSE ATTEMPTED TO DISCONNECT LUER LOCK SYRINGE FROM CATHETER HUB. CATHETER WAS EXCHANGED FOR A NEW CATHETER FOLLOWING THE INCIDENT." NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536738 ↗
• MalfunctionApr 7, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  CLINICIAN PLACED CATHETER THROUGH PASSAGE OF SHEATH. HE NOTICED A "GRABBING" AT THE SHEATH, BUT STILL ABLE TO PASS THROUGH UNTIL 1/4 ADVANCED LENGTH OF CATHETER. HE STATES HE MET RESISTANCE AND UNABLE TO ADVANCE CATHETER THROUGH SHEATH. AT THIS POINT HE ATTEMPTED TO RETRACT CATHETER WHILE HOLDING SHEATH IN PLACE. HE REPORTED SIGNIFICANT DIFFICULTY IN PULLING CATHETER BACK OUT AND STATED "IT WAS STUCK". PROCEDURE ABORTED. NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047432 ↗
• MalfunctionJan 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THE HUB FELL OFF THE EXTENSION LINE. THE PATIENT HAD FALLEN OFF THE X-RAY TABLE AND THE CATHETER "STRETCHED LIKE A RUBBER BAND". THE CATHETER HAD 2 CM OUT BEFORE THE INCIDENT AND STILL ONLY HAD 2CM OUT AFTER THE STRETCH FROM THE FALL, SO THE CATHETER DID NOT CHANGE POSITION. IT STRETCHED THE EXTENSION LINE. LATER THE STAFF WAS REPOSITIONING THE PATIENT IN HIS BED AND THE CATHETER GOT HUNG UP IN THE BEDRAIL. IT WAS AT THAT POINT THE HUB SEPARATED FROM THE EXTENSION LINE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397816 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122545. One submission often covers many models, so check the product and lot details in each record.

• Z-2378-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR
• Z-1030-2015 · Jan 9, 2015 · Terminated
  Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing