ARROW IPN924157Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902208610), received between Oct 15, 2024 and Sep 2, 2026 — classified as 1 injury, 4 malfunctions.

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

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

11 other recalls cover devices cleared under the same FDA submission (K112896); 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.

Recalls naming this device

1. Apr 21, 2026Open, 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-2370-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 50572772 ↗
• MalfunctionSep 2, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572736 ↗
• MalfunctionDec 3, 2024Material Separation; Material Separation

  IT WAS REPORTED "ONE OF OUR TEAM MEMBERS BROUGHT ME A BROKEN ARROWG+ARD BLUE SINGLE LUMEN PICC THIS AFTERNOON. IT APPEARS TO HAVE SEPARATED AT THE TOP OF THE WING AFTER THE PATIENT HAD DISCHARGED FROM THE FACILITY. THE LINE HAD BEEN APPROXIMATELY 1 MONTH AND IT WAS NOT ON REMOVAL. SHE STILL HAD TWO WEEKS OF ANTIBIOTICS SO WE PLACED ANOTHER PICC. THERE WERE NO PROBLEMS REPORTED BEFORE THIS." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836114 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INITIALLY BY A REPRESENTATIVE OF THE HEALTH CARE FACILITY "PICC INSERTION (B)(6) 2024 AT 12:27, 47CM RIGHT ARM, BASILIC VEIN. STERILE CHG GEL DRESSING USED. RAPID RESPONSE TEAM CALLED 20:43 (PATIENT FOUND SLUMPED IN CHAIR) DOD (B)(6) 24 AT 04:26." IT WAS RECEIVED VIA MEDWATCH "STERILE CHLORHEXIDINE GLUCONATE GEL DRESSING. START 12:15 END 12:27. RAPID RESPONSE TEAM CALLED FOR CONDITION CHANGE. PATIENT MINIMALLY RESPONSIVE TO PAINFUL STIMULATION. PATIENT PRESENTLY SLUMPED OVER IN BEDSIDE RECLINER. EXTREMITIES ESSENTIALLY FLACCID, POSSIBLY WITH RECENT POSTURING REPORTED." ADDITIONAL INFORMATION REPORTS THE CAUSE OF DEATH WAS "UNABLE TO DETERMINE, THE PATIENT WAS DNR AND AFTER DECLINE, FAMILY WISHED NO MORE INTERVENTIONS. SUBSEQUENTLY RECEIVED FROM THE HEALTH CARE FACILITY REPRESENTATIVE "SUSPECT RESPIRATORY OR POSSIBLE BRAIN BLEED PER NOTES. UNABLE TO HAVE CT SECONDARY TO ACUTE CONDITION; THE PROVIDER SUGGESTED A BRAIN BLEED VERSUS RESPIRATORY COMPROMISE."

  Patient problems: Insufficient Information

  MAUDE report 20507240 ↗
• MalfunctionOct 15, 2024Material Separation; Material Separation

  IT WAS REPORTED "SHEATH INTRODUCER BROKE AFTER REMOVING FROM THE PATIENT DURING A PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112896. 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-1820-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
• Z-1811-2019 · Apr 23, 2019 · Terminated
  Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
• Z-1819-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL
• Z-1822-2019 · Apr 23, 2019 · Terminated
  Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM
• Z-1327-2018 · Dec 22, 2017 · Terminated
  Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
• Z-0996-2018 · Nov 27, 2017 · Terminated
  Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow CVC is indicated to provide short-ter
• Z-2698-2017 · Jun 12, 2017 · Terminated
  Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
• Z-2331-2017 · May 9, 2017 · Terminated
  1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for
• Z-1705-2017 · Mar 3, 2017 · Terminated
  The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
• Z-0207-2016 · Oct 16, 2015 · Terminated
  ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS