ARROW IPN916439Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902165913), received between Nov 1, 2022 and Jan 25, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (4 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 25, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED WHEN OPENING THE PACKAGE, "THE WIRE WAS BROKEN". NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240401 ↗
• MalfunctionNov 6, 2022Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT "AFTER VISUAL VERIFICATION OF THE INTEGRITY OF THE DEVICE THEY PROCEEDED TO PUNCTURE THE RIGHT INTERNAL JUGULAR VEIN. WITH RA.CE.VA, THE NON-EXIT OF THE GUIDE FROM THE NEEDLE HAS BEEN DETECTED. AT THE ATTEMPT TO REMOVE THE GUIDE, RESISTANCE IS FELT, THEN THE NEEDLE IS CAREFULLY RETRACTED TOGETHER WITH THE GUIDE FROM THE VESSEL, AND COMPRESSION IS PERFORMED. ANALYSIS OF THE DEVICE SHOWS THE GUIDE WEDGED IN THE NEEDLE. THEN IT COMES OFF THE NEEDLE AND YOU NOTICE THE FRAYING / UNWINDING OF THE THREAD." NO PATIENT HARM REPORTED. ANOTHER CATHETER WAS USED AND INSERTED IN THE LEFT JUGULAR VEIN. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15741173 ↗
• MalfunctionNov 1, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  "PATIENT IS ADMITTED TO THE CARDIOVASCULAR ICU FROM THE HOSPITALIZATION AREA, THE GENERALIST PHYSICIAN ON DUTY PLACES A CENTRAL VENOUS CATHETER. THE CATHETER IS INSERTED INTO THE RIGHT SUBCLAVIAN VEIN, THE GUIDEWIRE IS INSERTED BUT WHEN ADVANCING THE CATHETER, THE GUIDEWIRE BENDS AND DOES NOT ALLOW THE PASSAGE OF CATHETER, THE CATHETER IS REMOVED. ANOTHER ATTEMPT IS MADE WITH A NEW CATHETER, BUT AGAIN THE GUIDEWIRE BENDS AND DURING ITS WITHDRAWAL THE GUIDEWIRE IS FULLY STRETCHED. THE INSERTION SITE IS CHANGED TO THE FEMORAL REGION, GUIDEWIRE AND CATHETER ARE PASSED, BUT WHEN REMOVING THE GUIDEWIRE, IT BENDS AND IT IS NOT POSSIBLE TO REMOVE IT, THE CATHETER IS COMPLETELY WITHDRAWN. AFTER THE SHIFT CHANGE, A FOURTH ATTEMPT IS MADE BY ANOTHER DOCTOR WITH SUCCESS." THE PATIENT'S CONDITION WAS REPORTED AS "CRITICAL", UNRELATED TO THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712248 ↗
• MalfunctionNov 1, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  "PATIENT IS ADMITTED TO THE CARDIOVASCULAR ICU FROM THE HOSPITALIZATION AREA, THE GENERALIST PHYSICIAN ON DUTY PLACES A CENTRAL VENOUS CATHETER. THE CATHETER IS INSERTED INTO THE RIGHT SUBCLAVIAN VEIN, THE GUIDEWIRE IS INSERTED BUT WHEN ADVANCING THE CATHETER, THE GUIDEWIRE BENDS AND DOES NOT ALLOW THE PASSAGE OF CATHETER, THE CATHETER IS REMOVED. ANOTHER ATTEMPT IS MADE WITH A NEW CATHETER, BUT AGAIN THE GUIDEWIRE BENDS AND DURING ITS WITHDRAWAL THE GUIDEWIRE IS FULLY STRETCHED. THE INSERTION SITE IS CHANGED TO THE FEMORAL REGION, GUIDEWIRE AND CATHETER ARE PASSED, BUT WHEN REMOVING THE GUIDEWIRE, IT BENDS AND IT IS NOT POSSIBLE TO REMOVE IT, THE CATHETER IS COMPLETELY WITHDRAWN. AFTER THE SHIFT CHANGE, A FOURTH ATTEMPT IS MADE BY ANOTHER DOCTOR WITH SUCCESS." THE PATIENT'S CONDITION WAS REPORTED AS "CRITICAL", UNRELATED TO THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712234 ↗
• MalfunctionNov 1, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  "PATIENT IS ADMITTED TO THE CARDIOVASCULAR ICU FROM THE HOSPITALIZATION AREA, THE GENERALIST PHYSICIAN ON DUTY PLACES A CENTRAL VENOUS CATHETER. THE CATHETER IS INSERTED INTO THE RIGHT SUBCLAVIAN VEIN, THE GUIDEWIRE IS INSERTED BUT WHEN ADVANCING THE CATHETER, THE GUIDEWIRE BENDS AND DOES NOT ALLOW THE PASSAGE OF CATHETER, THE CATHETER IS REMOVED. ANOTHER ATTEMPT IS MADE WITH A NEW CATHETER, BUT AGAIN THE GUIDEWIRE BENDS AND DURING ITS WITHDRAWAL THE GUIDEWIRE IS FULLY STRETCHED. THE INSERTION SITE IS CHANGED TO THE FEMORAL REGION, GUIDEWIRE AND CATHETER ARE PASSED, BUT WHEN REMOVING THE GUIDEWIRE, IT BENDS AND IT IS NOT POSSIBLE TO REMOVE IT, THE CATHETER IS COMPLETELY WITHDRAWN. AFTER THE SHIFT CHANGE, A FOURTH ATTEMPT IS MADE BY ANOTHER DOCTOR WITH SUCCESS." THE PATIENT'S CONDITION WAS REPORTED AS "CRITICAL", UNRELATED TO THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712220 ↗

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