ARROW IPN030093Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801902102164), received between Jul 3, 2023 and Mar 2, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Crack” (7 reports).

4 other recalls cover devices cleared under the same FDA submission (K970864); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Crack

  IT WAS REPORTED THAT "DOCTOR WAS ABOUT TO INSERT ACUTE DIALYSIS CATHETER IN ICU. DURING INSPECTION OF THE PRODUCT HE SAW THE CRACK ON NEEDLE HUB." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482551 ↗
• MalfunctionFeb 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT "LARGE BORE CATHETER SET OPENED AND THE PUNCTURE NEEDLE IN THE SET WAS TORN/SPLINTERED. THE USER NOTICED THIS WHEN AIR WAS ASPIRATED DURING HIGH JUGULAR PUNCTURE AND LONG SLENDER NECK (I.E. 10 CM ABOVE THE PLEURAL DOME)." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414091 ↗
• MalfunctionFeb 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE IS BENT". THERE WAS NO PATIENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344221 ↗
• MalfunctionJan 15, 2026Crack

  IT WAS REPORTED THAT "AS PER THE CLIN TECH, WHEN DOCTOR TRIED TO ASPIRATE AFTER PENETRATING THE PATIENTS SKIN, IT WAS THEN NOTICED THAT THE NEEDLE HUB WAS CRACKED. ANOTHER INTRODUCER NEEDLE USED TO COMPLETE THE PROCEDURE." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079434 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "DR WAS INSERTING THE LINE AS HE WAS STRUGGLING TO INSERT THE DILATOR THROUGH SKIN, HE REALIZED IT WAS NOT SMOOTH AT THE TIP" A NEW SET WAS USED, AND THE SECOND ATTEMPT WAS SUCCESSFUL. THERAPY WAS DELAYED BUT THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715919 ↗
• MalfunctionNov 25, 2024Crack; Crack

  IT WAS REPORTED "THE UNIT MANAGER OF (B)(6) HOSPITAL CALLED ME YESTERDAY AFTERNOON 28/10/24 INFORMING ME THAT OVER THE PAST WEEKEND HER STAFF HAD BEEN ASSISTING {DOCTOR} WITH INSERTION OF DIALYSIS CATHETER AND WHEN {DOCTOR} TRIED TO ASPIRATE THERE WAS AIR COMING OUT AND STAFF AND DOCTOR NOTICED A CRACK IN THE NEEDLE HUB. A SECOND, THIRD AND FOURTH SET WAS OPENED WITH ALL 4 SETS HAVING THE SIMILAR CRACKED NEEDLE HUB. A FIFTH SET WAS OPENED AND THE NEEDLE WAS NOT CRACKED AND THE PROCEDURE COMPLETED. ALL 4 DEFECTIVE NEEDLES WERE DISCARDED DESPITE STAFF BEING TOLD TO KEEP THEM FOR INVESTIGATION." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-01140, 3006425876-2024-01139 AND 3006425876-2024-01138.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771540 ↗
• MalfunctionNov 25, 2024Crack; Crack

  IT WAS REPORTED THAT " THE UNIT MANAGER OF MEDICAL ICU AT (B)(6) HOSPITAL CALLED ME YESTERDAY AFTERNOON (B)(6) 2024 INFORMING ME THAT OVER THE PAST WEEKEND HER STAFF HAD BEEN ASSISTING {DOCTOR} WITH INSERTION OF DIALYSIS CATHETER AND WHEN {DOCTOR} TRIED TO ASPIRATE THERE WAS AIR COMING OUT AND STAFF AND DOCTOR NOTICED A CRACK IN THE NEEDLE HUB. A SECOND, THIRD AND FOURTH SET WAS OPENED WITH ALL 4 SETS HAVING THE SIMILAR CRACKED NEEDLE HUB. A FIFTH SET WAS OPENED AND THE NEEDLE WAS NOT CRACKED AND THE PROCEDURE COMPLETED. ALL 4 DEFECTIVE NEEDLES WERE DISCARDED DESPITE STAFF BEING TOLD TO KEEP THEM FOR INVESTIGATION." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-01140, 3006425876-2024-01139, AND 3006425876-2024-01128.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771420 ↗
• MalfunctionNov 25, 2024Crack; Crack

  IT WAS REPORTED THAT " THE UNIT MANAGER OF (B)(6) HOSPITAL CALLED ME YESTERDAY AFTERNOON (B)(6) 2024 INFORMING ME THAT OVER THE PAST WEEKEND HER STAFF HAD BEEN ASSISTING {DOCTOR} WITH INSERTION OF DIALYSIS CATHETER AND WHEN {DOCTOR} TRIED TO ASPIRATE THERE WAS AIR COMING OUT AND STAFF AND DOCTOR NOTICED A CRACK IN THE NEEDLE HUB. A SECOND, THIRD AND FOURTH SET WAS OPENED WITH ALL 4 SETS HAVING THE SIMILAR CRACKED NEEDLE HUB. A FIFTH SET WAS OPENED AND THE NEEDLE WAS NOT CRACKED AND THE PROCEDURE COMPLETED. ALL 4 DEFECTIVE NEEDLES WERE DISCARDED DESPITE STAFF BEING TOLD TO KEEP THEM FOR INVESTIGATION." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-01139, 3006425876-2024-01138, AND 3006425876-2024-01128.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771238 ↗
• MalfunctionNov 25, 2024Crack; Crack

  IT WAS REPORTED THAT " THE UNIT MANAGER OF (B)(6) HOSPITAL CALLED ME YESTERDAY AFTERNOON (B)(6) 2024 INFORMING ME THAT OVER THE PAST WEEKEND HER STAFF HAD BEEN ASSISTING {DOCTOR} WITH INSERTION OF DIALYSIS CATHETER AND WHEN {DOCTOR} TRIED TO ASPIRATE THERE WAS AIR COMING OUT AND STAFF AND DOCTOR NOTICED A CRACK IN THE NEEDLE HUB. A SECOND, THIRD AND FOURTH SET WAS OPENED WITH ALL 4 SETS HAVING THE SIMILAR CRACKED NEEDLE HUB. A FIFTH SET WAS OPENED AND THE NEEDLE WAS NOT CRACKED AND THE PROCEDURE COMPLETED. ALL 4 DEFECTIVE NEEDLES WERE DISCARDED DESPITE STAFF BEING TOLD TO KEEP THEM FOR INVESTIGATION." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-01140, 3006425876-2024-01138, AND 3006425876-2024-01128.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771231 ↗
• MalfunctionOct 16, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED "DURING THE PROCEDURE WHEN THE DOCTOR ATTEMPTED TO ASPIRATE IT WAS NOTICED THAT THERE WAS ONLY AIR COMING THROUGH. UPON INVESTIGATION OF THE NEEDLE BY THE DOCTOR IT WAS NOTICED THAT THERE WAS A CRACK ON THE HUB. ANOTHER COMPLETE SET WAS OPENED AND THE PROCEDURE COMPLETED SUCCESSFULLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459637 ↗
• MalfunctionApr 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "(B)(6) 2024, IN ICU, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212168 ↗
• MalfunctionApr 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "IN ICU, THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE SAME PATIENT." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212034 ↗
• MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR COMPLAINED THAT THE WIRES KINKED EASILY THEN HE CANNOT USE PROPERLY." THE DEVICE WAS REMOVED AND ANOTHER CVC WAS INSERTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITIONS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977805 ↗
• MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR COMPLAINED THAT THE WIRES KINKED EASILY THEN HE CANNOT USE PROPERLY." THE DEVICE WAS REMOVED AND ANOTHER CVC WAS INSERTED. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITIONS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977763 ↗
• MalfunctionDec 27, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: AFTER UNCOMPLICATED PLACEMENT OF CVC FOR DIALYSIS IN SUBCLAVIAN VEIN, DURING WITHDRAWAL OF A GUIDE WIRE, THE GUIDE WIRE BECAME UNCOILED. THE CVC WAS WITHDRAWN ALONG WITH UNCOILED GUIDE WIRE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 18397429 ↗
• MalfunctionSep 4, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT: THE DILATOR WAS SPLIT OPEN AFTER ATTEMPTING TO INSERT. THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675963 ↗
• MalfunctionAug 31, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THE PHYSICIAN WAS INSERTING THE LINE "ON A CRITICALLY ILL PATIENT, INSERTION WENT FINE BUT UPON REMOVING THE WIRE UNCOILED. IT APPEARS TO BE COMPLETELY REMOVED." THE PATIENT'S CONDITION WAS REPORTED AS CRITICAL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17666074 ↗
• MalfunctionJul 3, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "THE WIRE IS ANGLED IN THE CATHETER. THE USER HAS INJURED THEMSELVES DURING THIS PROCEDURE." ADDITIONAL INFORMATION RECEIVED REPORTS THE GUIDEWIRE KINKED AND UNRAVELED DURING REMOVAL FROM THE CATHETER. "THE DOCTOR PROBABLY HAD NO SIGNIFICANT INJURY ONLY THE GLOVE WAS DAMAGED". NO MEDICAL INTERVENTION WAS REPORTED FOR THE USER. THERE WAS NO PATIENT HARM. A NEW CATHETER WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 17247418 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970864. 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-1290-2022 · May 5, 2022 · Terminated
  Arrow Three-Lumen CVC
• Z-1672-2009 · May 8, 2009 · Terminated
  12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. The large-bore multiple-lumen catheter permits veno
• Z-1671-2009 · May 8, 2009 · Terminated
  12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. The large-bore multiple-lumen catheter permits venous