ARROW IPN924156Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902208603), received between Jan 2, 2024 and Sep 19, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 21, 2026Class IOpen, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2394-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831695 ↗
• MalfunctionNov 19, 2025Migration; Migration

  IT WAS REPORTED THAT "PATIENT HAD CHEST PAIN DURING THE INSERTION THAT WENT AWAY. PATIENT VISITED ED ON (B)(6) 2025, FOR CHEST PAIN THAT WAS MORE SEVERE THAN THEY FELT DURING THE INSERTION. 10/15/25 REPORTED TO GREATER BALTIMORE MEDICAL CENTER FOR CHEST PAIN, PATIENT SAID IT THEY WERE UNABLE TO LAY DOWN DUE TO IT BEING UNCOMFORTABLE. CHEST X-RAY SHOWED CATHETER APPEARS SHORT." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REPORTS "THE TEAM THINKS THAT THE CATHETER WAS PLACED ON THE SHORTER SIDE AND SINCE IT WAS INSERTED ON THE LEFT, IT MAY HAVE MIGRATED INTO THE AZYGOS CREATING THE PATIENT DISCOMFORT. THE PATIENT NO LONGER NEEDED THE PICC FOR THERAPY, SO THE TEAM REMOVED THE PICC AND PLACED AN ARROW AGBA MIDLINE WITHOUT ANY FURTHER ISSUES." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Pain

  MAUDE report 23595996 ↗
• MalfunctionNov 19, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT "PATIENT HAD RACING HEART DURING INSERTION." ADDITIONAL INFORMATION RECEIVED STATES "WHEN PATIENT VISITED THE ED FOR CHEST PAINS, THE INITIAL X RAY SHOWS THE CATHETER TIP DEEP INTO THE RIGHT ATRIUM. THE VASCULAR ACCESS TEAM PULLED THE CATHETER BACK 3CM. THE PATIENT STILL COMPLAINED OF CHEST PAIN; THEREFORE, THE TEAM PULLED BACK AN ADDITIONAL 1CM FOR A TOTAL FOR 4CM RETRACTED. FINAL X RAY SHOWS PROPER PLACEMENT AT 12CM EXTERNAL (LINE TRIMMED TO 50CM. VITALS WERE NORMAL WHEN PATIENT VISITED THE ED. NO FURTHER ISSUES." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Pain

  MAUDE report 23595547 ↗
• MalfunctionNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "ON (B)(6) 2025, PATIENT 103-031, A 22-YEAR-OLD FEMALE, PRESENTED TO THE CLINIC FOR SCHEDULED DEVICE PLACEMENT. SUBSEQUENTLY, ON (B)(6) 2025, THE SAME DAY THE DEVICE WAS REMOVED, THE PATIENT EXPERIENCED A NON-SERIOUS ADVERSE EVENT CHARACTERIZED BY 'LOCAL SITE PAIN'. THE CATHETER WAS REPLACED." ADDITONAL INFORMAION RECIEVED STATES "THE PICC TEAM EVALUATED THE PATIENT AND AFTER RECIEVING THE RESULTS FROM THE ULTRASOUND THAT SHOWED A BLOOD CLOT IN THE CEPHALIC VEIN, IN CONJUNCTION WITH THE PATIENT COMPLAINING OF INSERTION SITE PAIN, THE DECISON WAS MADE TO REMOVE THE PICC AND REPLACE IT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 23595272 ↗
• MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED "PICC NURSE WAS PLACING PICC LINE ON PATIENT USING VPS G4 WHEN A BLUE BULLSEYE SHOWED ON THE SCREEN BUT 20CM OF CATHETER WAS OUT OF THE PATIENT. AFTER AN X-RAY, THE PICC TIP OF SHOW N TO BE LOCATED AT THE SUBCLAVIAN VEIN. PICC NURSE CONFIRMED THAT THE LINE WAS NOT IN A ARTERY. PATIENT WAS UNHARMED DURING THE PROCEDURE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309496 ↗
• MalfunctionJan 2, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT: CLINICIAN NOTICED SOME SLIGHT RESISTANCE, WHEN TRYING TO ADVANCE PICC THRU PEEL-AWAY SHEATH INTRODUCER. CLINICIAN WAS ABLE TO MAKE IT WORK , & THE PROCEDURE WAS COMPLETED SUCCESSFULLY, BUT THIS WAS NOT A NORMAL EXPERIENCE FOR THE CLINICIAN. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424212 ↗

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