ARROW IPN056359Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902161793), received between Jan 25, 2021 and Feb 21, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "BROKEN TUBING BLACK PORT LEAKING". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409310 ↗
• MalfunctionAug 23, 2021Material Separation; Material Separation

  PATIENT HAD A TRIPLE LUMEN PICC AND ONE OF THE HUBS POPPED OFF WHILE THE UNIT NURSE WAS CARING FOR THE PATIENT. THE USER CLAMPED THE BROKEN LUMEN, PLACED A NEW PICC, AND THEN REMOVED THE INITIAL CATHETER. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356193 ↗
• MalfunctionJan 25, 2021Material Separation; Material Separation

  CUSTOMER REPORTED "SLIDE CLAMPS ARE TOO TIGHT WHICH CAN RESULT IN TORQUING OF THE HUB WHEN TRYING TO CLAMP OR UNCLAMP." THIS CAUSES THE HUB TO "POP OFF" AND THE PICC NEEDS TO BE REPLACED. NO PATIENT HARM WAS REPORTED. PATIENT CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228216 ↗
• MalfunctionJan 25, 2021Material Separation; Material Separation

  CUSTOMER REPORTED "SLIDE CLAMPS ARE TOO TIGHT WHICH CAN RESULT IN TORQUING OF THE HUB WHEN TRYING TO CLAMP OR UNCLAMP". THIS CAUSES THE HUB TO "POP OFF" AND THE PICC NEEDS TO BE REPLACED. NO PATIENT HARM WAS REPORTED. PATIENT CONDITION REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228100 ↗

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