ARROW IPN036964Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 70801902123304), received between Apr 8, 2022 and Apr 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "PLACEMENT OF HEMODIALYSIS LINE WAS PERFORMED. INSERTION AND DILATION WAS SMOOTH WITHOUT ISSUES. WHEN REMOVING CATHETER, THERE WAS NO RESISTANCE UNTIL IT WAS NOTED TO BE UNCOILING. REMOVAL OF GUIDEWIRE WAS THEN STOPPED. ATTENDING CAME TO BEDSIDE AND HEMODIALYSIS CATHETER HAD TO BE COMPLETELY REMOVED. DUE TO PATIENT HAVING LOW PLATELETS, THERE WAS LARGE AMOUNTS OF BLOOD DRAINING FROM SITE. A HEMATOMA FORMED. FEM STOP HAD TO BE APPLIED. LOT# 13F21E0294. WHEN ADVANCING THE CATHETER, THE WIRE SUDDENLY BECAME UNABLE TO EXCHANGE EASILY. UPON ATTEMPTING TO REMOVE THE WIRE FROM THE CATHETER, THE METAL PULLED APART. THE PLACEMENT OF THE CATHETER WAS CHECKED MULTIPLE TIMES USING THE ULTRASOUND, THE CATHETER WAS FOUND TO BE ENTERING INTO THE VEIN. AT THIS POINT, WE CLAMPED THE WIRE INSIDE THE CATHETER AND REMOVED BOTH THE WIRE AND THE DEVICE FROM THE LEFT FEMORAL VEIN. PRESSURE WAS HELD ON THE SITE OF THE VENOUS DILATION FOR 45 MINUTES AND PLATELETS WERE GIVEN. WE TRANSITIONED HANDHELD PRESSURE TO A FEM STOP DEVICE ON THE LEFT GROIN. THE FEM STOP WAS REMOVED PER PROTOCOL AFTER A FEW HOURS WITH NO FURTHER BLEEDING. ALSO, THE ATTENDING PHYSICIAN DOCUME

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14057753 ↗

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