ARROW IPN927347Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10801902213553), received between Jan 23, 2024 and Dec 1, 2025 — classified as 2 injuries, 8 malfunctions.

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

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

5 other recalls cover devices cleared under the same FDA submission (K993933); 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-2388-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "WHEN USING THE RAULERSON SYRINGE THE PHYSICIAN STATED THAT WHEN PULLING BACK ON THE PLUNGER NO BLOOD WAS PULLED BACK, ONLY AIR. PHYSICIAN DECIDED TO PULL ANOTHER KIT AND PLACE LINE ON THE OTHER SIDE OF THE PATIENT. THERE WAS NO REPORTED PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680790 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED "CATHETER WAS BEING PLACED IN THE IJ AND CUSTOMER EXPERIENCED DIFFICULTY PASSING THE CATHETER OVER THE WIRE. CUSTOMER IS REPORTING THE WIRE WAS FLIMSY AND BENT." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO DELAY TO THERAPY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 19279732 ↗
• MalfunctionMay 9, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "PHYSICIAN STATED THAT CATHETER WOULD NOT PASS INTO PATIENT WIRE AND DILATOR AND WIRE WENT SMOOTH BUT CATHETER GOT HUNG UP AROUND THE SIDE HOLES CATHETER WOULDN'T GO." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. NO DELAY TO THERAPY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19278561 ↗
• InjuryFeb 16, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CLIENT COMPLAINED THAT THE PLASTIC ON THE CATHETER IS TOO RIDGED. THEY REPORTED THAT THIS CAUSE CAUSED BRACHIOCEPHALIC INJURY, WHICH HAD TO BE "FIXED". ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT.

  Patient problems: Laceration(s)

  MAUDE report 18720975 ↗
• InjuryFeb 16, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE CLIENT COMPLAINED THAT THE PLASTIC ON THE CATHETER IS TOO RIDGED. THEY REPORTED THAT THIS CAUSE CAUSED BRACHIOCEPHALIC INJURY, WHICH HAD TO "FIXED". ADDITIONAL INFORMATION WAS REQUESTED FROM THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719410 ↗
• MalfunctionJan 23, 2024Material Twisted/Bent; Material Twisted/Bent

  WE ELECTED TO PLACE A TEMPORARY HD CATHETER IN THE FEMORAL VEIN ON THE R BECAUSE OF ACCESS ISSUES. WE WERE ABLE TO EASILY ACCESS THE VEIN USING US GUIDANCE. WE THREAD THE WIRE AND CONFIRMED VENOUS PLACEMENT. A LARGE SKIN INCISION WAS MADE TO ACCOMMODATE THE DILATORS AND CATHETER. THE PROBLEM BEGAN UPON DILATION. WE ENCOUNTERED MORE RESISTANCE THAN EXPECTED DURING DILATION AND UPON TRYING TO ADVANCE THE CATHETER ON THE FIRST ATTEMPT. I ATTEMPTED TO ADVANCE THE CATHETER MYSELF BUT WAS UNSUCCESSFUL. AT THAT TIME, I ELECTED TO PULL THE CATHETER OUT, CHANGE TRY ANOTHER KIT. I THREADED A CATHETER OVER THE WIRE, REMOVED THE OLD WIRE WHICH HAD A VERY SMALL KINK AND REPLACE IT WITH A NEW WIRE. I THEN RE-DILATED WITH BOTH DILATORS AND THEN TRIED TO ADVANCE THE NEW 20CM 14F HD CATHETER. I WAS UNSUCCESSFUL. I MET A SIGNIFICANT AMOUNT OF RESISTANCE, APPROXIMATELY 8-10CM IN, AND DESPITE MANY MANEUVERS TO ADVANCE, I WAS UNSUCCESSFUL. THE CATHETER WAS TOO SOFT AND WOULD START TO KINK UNDER THE SKIN. 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 18562364 ↗
• MalfunctionJan 23, 2024Material Deformation; Material Deformation

  WE ELECTED TO PLACE A TEMPORARY HD CATHETER IN THE FEMORAL VEIN ON THE R BECAUSE OF ACCESS ISSUES. WE WERE ABLE TO EASILY ACCESS THE VEIN USING US GUIDANCE. WE THREAD THE WIRE AND CONFIRMED VENOUS PLACEMENT. A LARGE SKIN INCISION WAS MADE TO ACCOMMODATE THE DILATORS AND CATHETER. THE PROBLEM BEGAN UPON DILATION. WE ENCOUNTERED MORE RESISTANCE THAN EXPECTED DURING DILATION AND UPON TRYING TO ADVANCE THE CATHETER ON THE FIRST ATTEMPT. I ATTEMPTED TO ADVANCE THE CATHETER MYSELF BUT WAS UNSUCCESSFUL. AT THAT TIME, I ELECTED TO PULL THE CATHETER OUT, CHANGE TRY ANOTHER KIT. I THREADED A CATHETER OVER THE WIRE, REMOVED THE OLD WIRE WHICH HAD A VERY SMALL KINK AND REPLACE IT WITH A NEW WIRE. I THEN RE-DILATED WITH BOTH DILATORS AND THEN TRIED TO ADVANCE THE NEW 20CM 14F HD CATHETER. I WAS UNSUCCESSFUL. I MET A SIGNIFICANT AMOUNT OF RESISTANCE, APPROXIMATELY 8-10CM IN, AND DESPITE MANY MANEUVERS TO ADVANCE, I WAS UNSUCCESSFUL. THE CATHETER WAS TOO SOFT AND WOULD START TO KINK UNDER THE SKIN. 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 18562015 ↗
• MalfunctionJan 23, 2024Material Deformation; Material Deformation

  WE ELECTED TO PLACE A TEMPORARY HD CATHETER IN THE FEMORAL VEIN ON THE R BECAUSE OF ACCESS ISSUES. WE WERE ABLE TO EASILY ACCESS THE VEIN USING US GUIDANCE. WE THREAD THE WIRE AND CONFIRMED VENOUS PLACEMENT. A LARGE SKIN INCISION WAS MADE TO ACCOMMODATE THE DILATORS AND CATHETER. THE PROBLEM BEGAN UPON DILATION. WE ENCOUNTERED MORE RESISTANCE THAN EXPECTED DURING DILATION AND UPON TRYING TO ADVANCE THE CATHETER ON THE FIRST ATTEMPT. I ATTEMPTED TO ADVANCE THE CATHETER MYSELF BUT WAS UNSUCCESSFUL. AT THAT TIME, I ELECTED TO PULL THE CATHETER OUT, CHANGE TRY ANOTHER KIT. I THREADED A CATHETER OVER THE WIRE, REMOVED THE OLD WIRE WHICH HAD A VERY SMALL KINK AND REPLACE IT WITH A NEW WIRE. I THEN RE-DILATED WITH BOTH DILATORS AND THEN TRIED TO ADVANCE THE NEW 20CM 14F HD CATHETER. I WAS UNSUCCESSFUL. I MET A SIGNIFICANT AMOUNT OF RESISTANCE, APPROXIMATELY 8-10CM IN, AND DESPITE MANY MANEUVERS TO ADVANCE, I WAS UNSUCCESSFUL. THE CATHETER WAS TOO SOFT AND WOULD START TO KINK UNDER THE SKIN. 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 18561999 ↗
• MalfunctionJan 23, 2024Material Deformation; Material Deformation

  WE ELECTED TO PLACE A TEMPORARY HD CATHETER IN THE FEMORAL VEIN ON THE R BECAUSE OF ACCESS ISSUES. WE WERE ABLE TO EASILY ACCESS THE VEIN USING US GUIDANCE. WE THREAD THE WIRE AND CONFIRMED VENOUS PLACEMENT. A LARGE SKIN INCISION WAS MADE TO ACCOMMODATE THE DILATORS AND CATHETER. THE PROBLEM BEGAN UPON DILATION. WE ENCOUNTERED MORE RESISTANCE THAN EXPECTED DURING DILATION AND UPON TRYING TO ADVANCE THE CATHETER ON THE FIRST ATTEMPT. I ATTEMPTED TO ADVANCE THE CATHETER MYSELF BUT WAS UNSUCCESSFUL. AT THAT TIME, I ELECTED TO PULL THE CATHETER OUT, CHANGE TRY ANOTHER KIT. I THREADED A CATHETER OVER THE WIRE, REMOVED THE OLD WIRE WHICH HAD A VERY SMALL KINK AND REPLACE IT WITH A NEW WIRE. I THEN RE-DILATED WITH BOTH DILATORS AND THEN TRIED TO ADVANCE THE NEW 20CM 14F HD CATHETER. I WAS UNSUCCESSFUL. I MET A SIGNIFICANT AMOUNT OF RESISTANCE, APPROXIMATELY 8-10CM IN, AND DESPITE MANY MANEUVERS TO ADVANCE, I WAS UNSUCCESSFUL. THE CATHETER WAS TOO SOFT AND WOULD START TO KINK UNDER THE SKIN. 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 18561983 ↗
• MalfunctionJan 23, 2024Material Deformation; Material Deformation

  WE ELECTED TO PLACE A TEMPORARY HD CATHETER IN THE FEMORAL VEIN ON THE R BECAUSE OF ACCESS ISSUES. WE WERE ABLE TO EASILY ACCESS THE VEIN USING US GUIDANCE. WE THREAD THE WIRE AND CONFIRMED VENOUS PLACEMENT. A LARGE SKIN INCISION WAS MADE TO ACCOMMODATE THE DILATORS AND CATHETER. THE PROBLEM BEGAN UPON DILATION. WE ENCOUNTERED MORE RESISTANCE THAN EXPECTED DURING DILATION AND UPON TRYING TO ADVANCE THE CATHETER ON THE FIRST ATTEMPT. I ATTEMPTED TO ADVANCE THE CATHETER MYSELF BUT WAS UNSUCCESSFUL. AT THAT TIME, I ELECTED TO PULL THE CATHETER OUT, CHANGE TRY ANOTHER KIT. I THREADED A CATHETER OVER THE WIRE, REMOVED THE OLD WIRE WHICH HAD A VERY SMALL KINK AND REPLACE IT WITH A NEW WIRE. I THEN RE-DILATED WITH BOTH DILATORS AND THEN TRIED TO ADVANCE THE NEW 20CM 14F HD CATHETER. I WAS UNSUCCESSFUL. I MET A SIGNIFICANT AMOUNT OF RESISTANCE, APPROXIMATELY 8-10CM IN, AND DESPITE MANY MANEUVERS TO ADVANCE, I WAS UNSUCCESSFUL. THE CATHETER WAS TOO SOFT AND WOULD START TO KINK UNDER THE SKIN. 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 18561800 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993933. One submission often covers many models, so check the product and lot details in each record.

• Z-2373-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYS
• Z-1336-2018 · Dec 22, 2017 · Terminated
  ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1
• Z-0658-2018 · Oct 17, 2017 · Terminated
  ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2
• Z-2334-2017 · May 9, 2017 · Terminated
  1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation
• Z-0639-04 · Feb 18, 2004 · Terminated
  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions