ARROW IPN030921Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902029345), received between Jul 6, 2021 and Jul 5, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K900263); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT " IDENTIFICATION OF THE VEIN, INSERTION OF THE SWG AND DILATOR - WITHOUT PROBLEMS. THE CENTRAL CATHETER WAS INSERTED OVER THE SWG. UPON REMOVING THE SWG FROM THE CENTRAL CATHETER, DAMAGE WAS OBSERVED (SPLITTING IN THE DISTAL THIRD OF THE SWG)." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19678031 ↗
• MalfunctionSep 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT "INCIDENT OCCURRED WHILE REPOSITIONING THE PATIENT WHO WAS INTUBATED AND VENTILATED AT THE TIME. AFTER ROLLING, I WAS REMOVING THE GLIDE SHEETS THAT WAS UNDERNEATH THE PATIENT. HIS CENTRAL VENOUS CATHETER (CVC) WAS IN THE RIGHT SIDE OF THE NECK AT THE TIME OF THE INCIDENT. THERE WAS ONE PORT ON THE CVC THAT WAS NOT CONNECTED TO ANY INFUSIONS AND WHILE I WAS REMOVING THE SLIDE SHEETS BY PULLING, THE PORT MUST HAVE BECOME STUCK IN THE GLIDE SHEET AND THE WHITE PORT AND BIONECTOR THAT WAS ATTACHED TO THE WHITE PORT SNAPPED OFF. I HEARD A LOUD POP AND SAW THAT THERE WAS NOW AN OPEN LINE ON THE CVC." ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17758890 ↗
• InjuryJul 6, 2021Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTED THAT "PATIENT HAS HAD THIS CENTRAL LINE IN FOR 3 DAYS. BLOOD PRODUCTS WERE RAN THROUGH THE TRANSDUCER LINE BY DAY STAFF. ONCE FINISHED, I FLUSHED THE TRANSDUCER LINE AND THIS SUBSEQUENTLY CAUSED PATIENT'S SYSTOLIC TO RISE TO 250. I THEN STOPPED THE NORAD (12/50) AND SLOWLY REINTRODUCED. DUE TO CONCERN THAT THE TRANSDUCER SOMEHOW FLUSHED THE NORAD EVEN THOUGH THEY ARE ON SEPARATE LUMENS, I TRANSFERRED THE NORAD TO ANOTHER LUMEN. I THEN FLUSHED ANOTHER LUMEN ON THE CENTRAL LINE AND THIS HAPPENED AGAIN. IN TOTAL FLUSHING THE CENTRAL LINE CAUSED PATIENT'S SYSTOLIC TO RISE TO UNSAFE RANGES 3 TIMES." THE CVC LINE WAS CHANGED. NO OTHER MEDICAL INTERVENTION WAS REPORTED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 12122465 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900263. One submission often covers many models, so check the product and lot details in each record.

• Z-2376-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
• Z-0053-2020 · May 17, 2019 · Terminated
  Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous acces
• Z-2886-2018 · Jul 3, 2018 · Terminated
  Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous acc
• Z-1984-2018 · Apr 11, 2018 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
• Z-1985-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
• Z-1333-2018 · Dec 22, 2017 · Terminated
  ARROWg+ard Blue CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheter
• Z-1001-2018 · Nov 27, 2017 · Terminated
  ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or condi
• Z-2337-2017 · May 9, 2017 · Terminated
  ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
• Z-1830-2012 · May 3, 2012 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circ
• Z-2496-2010 · Jul 29, 2010 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
• Z-1499-2009 · Feb 11, 2009 · Terminated
  Arrow ARROWg+ard CVCs (Central Venous Catheters)
• Z-0082-04 · Sep 16, 2003 · Terminated
  Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm