ARROW IPN916994Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902167795), received between Apr 7, 2023 and Apr 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

11 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.

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-2376-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. 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-2388-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionApr 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "I WAS FIRST CONTACTED ABOUT A DILATOR ISSUE IN THE SMALL VEIN CVC KITS BY A CLINICAL RESOURCE DIRECTOR IN AN EMAIL ON 3/2. SHE DID NOT HAVE ANY INFORMATION ABOUT THE COMPLAINT, SO SHE CONNECTED ME TO THE END USERS. IT TOOK A WHILE TO GET IN TOUCH WITH THESE END USERS (MDS IN THE PICU) AND YESTERDAY 3/13 WAS THE FIRST AVAILABLE DATE THEY COULD MEET TO DISCUSS THE DETAILS OF THE DILATOR ISSUES. THE MDS IN THE PICU HAVE BEEN EXPERIENCING REPEATED DILATOR ISSUES IN THE SMALL VEIN CVC KITS. THEY REPORT THAT THE DILATOR IS SOFT AND BENDS AT OR NEAR THE TIP, MAKING IT DIFFICULT TO ADVANCE THE GUIDEWIRE OR KINKING THE GUIDEWIRE AS A RESULT. THEY ALSO REPORTED THAT THE DILATOR FRAYS. THEY TOLD ME THAT THIS HAS BEEN HAPPENING FOR SOME TIME, AND THAT IT REQUIRES THEM TO OFTEN OPEN ANOTHER KIT TO USE A SECOND DILATOR." ADDITIONAL INFORMATION RECEIVED STATED THAT FOUR KITS WERE USED, ALL FOUR DEVICES WERE BENDING OR FREYING. ALL FOUR DEVICES WERE USED ON DIFFERENT PATIENTS THERE WAS NO INJURY OR HARM. NO MEDICAL INTERVENTION WAS REQUIRED. ALL FOUR PATIENT CONDITIONS ARE REPORTED TO BE "FINE". THERE WAS A DELAY IN THERAPY AS THEY HAD TO RETRIEVE AND OPEN ANOTHER KIT FOR A NEW DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700670 ↗
• MalfunctionApr 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "I WAS FIRST CONTACTED ABOUT A DILATOR ISSUE IN THE SMALL VEIN CVC KITS BY A CLINICAL RESOURCE DIRECTOR IN AN EMAIL ON (B)(6) 2023. SHE DID NOT HAVE ANY INFORMATION ABOUT THE COMPLAINT, SO SHE CONNECTED ME TO THE END USERS. IT TOOK A WHILE TO GET IN TOUCH WITH THESE END USERS (MDS IN THE PICU) AND YESTERDAY (B)(6) 2023 WAS THE FIRST AVAILABLE DATE THEY COULD MEET TO DISCUSS THE DETAILS OF THE DILATOR ISSUES. THE MDS IN THE PICU HAVE BEEN EXPERIENCING REPEATED DILATOR ISSUES IN THE SMALL VEIN CVC KITS. THEY REPORT THAT THE DILATOR IS SOFT AND BENDS AT OR NEAR THE TIP, MAKING IT DIFFICULT TO ADVANCE THE GUIDEWIRE OR KINKING THE GUIDEWIRE AS A RESULT. THEY ALSO REPORTED THAT THE DILATOR FRAYS. THEY TOLD ME THAT THIS HAS BEEN HAPPENING FOR SOME TIME, AND THAT IT REQUIRES THEM TO OFTEN OPEN ANOTHER KIT TO USE A SECOND DILATOR." ADDITIONAL INFORMATION RECEIVED STATED THAT FOUR KITS WERE USED, ALL FOUR DEVICES WERE BENDING OR FREYING. ALL FOUR DEVICES WERE USED ON DIFFERENT PATIENTS THERE WAS NO INJURY OR HARM. NO MEDICAL INTERVENTION WAS REQUI RED. ALL FOUR PATIENT CONDITIONS ARE REPORTED TO BE "FINE". THERE WAS A DELAY IN THERAPY AS THEY HAD TO RETRIEVE AND OPEN ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700647 ↗
• MalfunctionApr 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "I WAS FIRST CONTACTED ABOUT A DILATOR ISSUE IN THE SMALL VEIN CVC KITS BY A CLINICAL RESOURCE DIRECTOR IN AN EMAIL ON (B)(6). SHE DID NOT HAVE ANY INFORMATION ABOUT THE COMPLAINT, SO SHE CONNECTED ME TO THE END USERS. IT TOOK A WHILE TO GET IN TOUCH WITH THESE END USERS (MDS IN THE PICU) AND YESTERDAY (B)(6) WAS THE FIRST AVAILABLE DATE THEY COULD MEET TO DISCUSS THE DETAILS OF THE DILATOR ISSUES. THE MDS IN THE PICU HAVE BEEN EXPERIENCING REPEATED DILATOR ISSUES IN THE SMALL VEIN CVC KITS. THEY REPORT THAT THE DILATOR IS SOFT AND BENDS AT OR NEAR THE TIP, MAKING IT DIFFICULT TO ADVANCE THE GUIDEWIRE OR KINKING THE GUIDEWIRE AS A RESULT. THEY ALSO REPORTED THAT THE DILATOR FRAYS. THEY TOLD ME THAT THIS HAS BEEN HAPPENING FOR SOME TIME, AND THAT IT REQUIRES THEM TO OFTEN OPEN ANOTHER KIT TO USE A SECOND DILATOR." ADDITIONAL INFORMATION RECEIVED STATED THAT FOUR KITS WERE USED, ALL FOUR DEVICES WERE BENDING OR FREYING. ALL FOUR DEVICES WERE USED ON DIFFERENT PATIENTS THERE WAS NO INJURY OR HARM. NO MEDICAL INTERVENTION WAS REQUIRED. ALL FOUR PATIENT CONDITIONS ARE REPORTED TO BE "FINE". THERE WAS A DELAY IN THERAPY AS THEY HAD TO RETRIEVE AND OPEN ANOTHER KIT FOR A N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700516 ↗
• MalfunctionApr 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED "I WAS FIRST CONTACTED ABOUT A DILATOR ISSUE IN THE SMALL VEIN CVC KITS BY A CLINICAL RESOURCE DIRECTOR IN AN EMAIL ON 3/2. SHE DID NOT HAVE ANY INFORMATION ABOUT THE COMPLAINT, SO SHE CONNECTED ME TO THE END USERS. IT TOOK A WHILE TO GET IN TOUCH WITH THESE END USERS (MDS IN THE PICU) AND YESTERDAY 3/13 WAS THE FIRST AVAILABLE DATE THEY COULD MEET TO DISCUSS THE DETAILS OF THE DILATOR ISSUES. THE MDS IN THE PICU HAVE BEEN EXPERIENCING REPEATED DILATOR ISSUES IN THE SMALL VEIN CVC KITS. THEY REPORT THAT THE DILATOR IS SOFT AND BENDS AT OR NEAR THE TIP, MAKING IT DIFFICULT TO ADVANCE THE GUIDEWIRE OR KINKING THE GUIDEWIRE AS A RESULT. THEY ALSO REPORTED THAT THE DILATOR FRAYS. THEY TOLD ME THAT THIS HAS BEEN HAPPENING FOR SOME TIME, AND THAT IT REQUIRES THEM TO OFTEN OPEN ANOTHER KIT TO USE A SECOND DILATOR." ADDITIONAL INFORMATION RECEIVED STATED THAT FOUR KITS WERE USED, ALL FOUR DEVICES WERE BENDING OR FREYING. ALL FOUR DEVICES WERE USED ON DIFFERENT PATIENTS THERE WAS NO INJURY OR HARM. NO MEDICAL INTERVENTION WAS REQUI RED. ALL FOUR PATIENT CONDITIONS ARE REPORTED TO BE "FINE". THERE WAS A DELAY IN THERAPY AS THEY HAD TO RETRIEVE AND OPEN ANOTHER KIT FOR A NEW D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16700497 ↗

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-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