ARROW IPN032917Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902007858), received between Aug 17, 2023 and Jan 26, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "GUIDEWIRE KINKING WHILE TRYING TO THREAD, UNABLE TO PLACE CENTRAL LINE." GUIDEWIRE WAS REMOVED AND A NEW KIT WAS USED. NO HARM OR HEALTH CONSEQUENCE. PATIENT'S CURRENT CONDITION IS "FINE" AT THE TIME OF THIS REPORT. ASSOCIATED MDR NUMBERS 9680794-2024-00065 AND 9680794-2024-00066.

  Patient problems: Insufficient Information

  MAUDE report 18591831 ↗
• MalfunctionJan 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "GUIDEWIRE KINKING WHILE TRYING TO THREAD, UNABLE TO PLACE CENTRAL LINE." THE DEVICE WAS REMOVED AND A NEW KIT WAS USED. NO HARM OR HEALTH CONSEQUENCE. PATIENT'S CURRENT CONDITION IS "FINE" AT THE TIME OF THIS REPORT. ASSOCIATED MDR NUMBER 9680794-2024-00066 AND 9680794-2024-00067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591426 ↗
• MalfunctionJan 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "GUIDEWIRE KINKING WHILE TRYING TO THREAD, UNABLE TO PLACE CENTRAL LINE." GUIDEWIRE WAS REMOVED AND A NEW KIT WAS USED. NO PATIENT HARM OR INJURY. PATIENT'S CURRENT CONDITION IS "FINE" AT THE TIME OF THIS REPORT. ASSOCIATED MDR NUMBER 9680794-2024-00065 AND 9680794-2024-00067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591418 ↗
• InjuryAug 17, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THE PATIENT HAD AN ALLERGIC REACTION TO THE CATHETER. THE PATIENT HAD A KNOWN ALLERGY TO CHLORHEXIDINE WITH PREVIOUS ANAPHYLAXIS TO SKIN PREP FOR PERIPHERAL IV 4 MONTHS EARLIER. THE PATIENT EXPERIENCED ERYTHEMA AT THE INSERTION SITE, RESPIRATORY DISTRESS WITH AGONAL RESPIRATION, NO PULSE, AND PULSELESS ELECTRICAL ACTIVITY. THE PATIENT WAS TREATED WITH CPR FOR 45 MINUTES, EPINEPHRINE IV, INTUBATION, CARDIOVERSION, AND SOLUMEDROL. THE PATIENT WAS STABILIZED AND DISCHARGED HOME FROM THE ICU AFTER 5 DAYS. IT WAS REPORTED THE PATIENT EXPERIENCED SEVERE PSYCHOLOGICAL DISTRESS REQUIRING ON-GOING INTERVENTION.

  Patient problems: Adult Respiratory Distress Syndrome; Anaphylactic Shock; Cardiac Arrest; Erythema

  MAUDE report 17562993 ↗

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-1985-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
• 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-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