ARROW IPN035912Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00801902002730), received between May 25, 2016 and May 5, 2026 — classified as 14 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 reports).

32 other recalls cover devices cleared under the same FDA submission (K810675); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Material Twisted/Bent

  IT WAS REPORTED THAT, "DURING PREPARATION PRIOR TO THE ARTERIAL LINE PROCEDURE, THE GUIDEWIRE KINKED AND COULD NOT BE ADVANCED." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081827 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT "WE HAD A RADIAL ARTERY CATHETERIZATION SET RA-04020 WHERE THE WIRE BROKE IN HALF WHEN INSERTING THE CATHETER INTO THE RADIAL ARTERY". 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 24910612 ↗
• InjuryMar 23, 2026Break

  IT WAS REPORTED "DURING THE PROCEDURE, A PORTION OF THE CATHETER BROKE OFF WITHIN THE PATIENT'S RADIAL ARTERY. THE OPERATING SURGEON WAS IMMEDIATELY NOTIFIED, AND A VASCULAR SURGERY CONSULT WAS OBTAINED. ULTRASOUND IMAGING WAS PERFORMED, AND THE RETAINED CATHETER FRAGMENT WAS VISUALIZED WITHIN THE PATIENT'S RADIAL ARTERY". THERE WAS NO PATIENT HARM OR INJURY. ADDITIONAL INFORMATION RECEIVED STATES "THE CATHETER FRAGMENT REMAINS IN SITU, AND THE VASCULAR SURGERY TEAM IS ACTIVELY FOLLOWING AND MANAGING THE PATIENT".

  Patient problems: Foreign Body In Patient

  MAUDE report 24662726 ↗
• InjuryFeb 4, 2026Material Separation

  IT WAS REPORTED THAT " WHILE PLACING THE A-LINE A PIECE OF THE WIRE FROM THE RADIAL ARTERY CATHETERIZATION SET SEVERED OFF AND WAS RETAINED IN THE PATIENT. PIECE OF WIRE THAT WAS RETAINED IN THE PATIENT'S RIGHT WRIST WAS CONFIRMED VIA FLUORO AND ULTRASOUND. SURGICAL CONSULT IS BEING PLACED TO REMOVE THE FOREIGN BODY". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient

  MAUDE report 24257538 ↗
• MalfunctionDec 16, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT "NOT GETTING BLOOD FLASHBACK IN CHAMBER". 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 23817203 ↗
• MalfunctionDec 3, 2025Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED "X2 ARTERIAL CATHETERIZATION SETS WERE NOTED TO BE FAULTY. IT SEEMS THE CONNECTION POINT BETWEEN THE CANNULA AND THE NEEDLE DISLODGED INAPPROPRIATELY CAUSING THE NEEDLE TO BEND AND PUT A HOLE THROUGH THE CANNULA." A THIRD CANNULA WAS INSERTED AND USED SUCCESSFULLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE:9680794-2025-01045 AND 9680794-2025-01033.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705601 ↗
• MalfunctionDec 3, 2025Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  IT WAS REPORTED "X2 ARTERIAL CATHETERIZATION SETS WERE NOTED TO BE FAULTY. IT SEEMS THE CONNECTION POINT BETWEEN THE CANNULA AND THE NEEDLE DISLODGED INAPPROPRIATELY CAUSING THE NEEDLE TO BEND AND PUT A HOLE THROUGH THE CANNULA." A THIRD CANNULA WAS INSERTED AND USED SUCCESSFULLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE:9680794-2025-01045 AND 9680794-2025-01033.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705600 ↗
• MalfunctionOct 21, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT "DURING ARTERIAL PRESSURE MONITORING IN THE OPERATING ROOM USING AN RA CATHETER, THE NEEDLE TIP WAS NOT VISIBLE." A NEW KIT WAS USED. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347381 ↗
• MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "THE SET BROKE DOWN WHEN ATTEMPTING TO ADVANCE THE ACTUAL CATHETER OVER THE INCLUDED WIRE. THE WHOLE SET LOCKED UP AND HAD TO BE TAKEN OUT EN BLOC. AFTER INSPECTION, IT APPEARS AS IF THE CATHETER ITSELF WAS SPLIT FROM THE NORMAL DISTAL HOLE AND UP THE SIDE OF THE CATHETER FOR ABOUT 5-6 MM." ANOTHER CATHETER WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23016672 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  IT WAS REPORTED " 07/17: FELLOW ATTEMPTED TO PLACE RIGHT RADIAL A-LINE. THE FIRST SET THAT HE ATTEMPTED WITH WAS THE DEFECTIVE SET. THE NEEDLE SLID OUT AFTER FELLOW HAD PUNCTURED PATIENT'S SKIN. HE WAS ABLE TO REMOVE IT AND THE NEEDLE SLID COMPLETELY OUT OF THE PLASTIC SHEATH. THE RESIDENT, WENT TO RETRIEVE A SECOND INSERTION SET." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE AND UNCHANGED".

  Patient problems: Needle Stick/Puncture

  MAUDE report 22828003 ↗
• MalfunctionAug 18, 2025Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED "THE LEFT RADIAL ARTERY WAS IDENTIFIED WITH PALPATION AND ULTRASOUND AND A-LINE NEEDLE WAS ADVANCED UNTIL FLASH OF PULSATILE BRIGHT RED BLOOD WAS OBSERVED UP TO MARKER LINE. GUIDEWIRE WAS SMOOTHLY ADVANCED OVER THE CATHETER BUT THE CATHETER WOULD NOT ADVANCE OVER THE WIRE. THE WIRE WOULD NOT REMOVE AND IT WAS FOUND TO BE BROKEN. THE APPARATUS WAS REMOVED AND PRESSURE HELD. ON SCANNING A SMALL HEMATOMA WAS VISIBLE BUT NOT RETAINED WIRE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hematoma

  MAUDE report 22826680 ↗
• MalfunctionAug 11, 2025Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  IT WAS REPORTED "RADIAL ARTERIAL ART LINE INSERTION. CATHETER IN ARTERY AS PER ULTRASOUND GUIDE. GUIDE WIRE THREADED THROUGH CATHETER EASILY. UPON CATHETER INSERTION OVER GUIDE WIRE, RESISTANCE FELT. CATHETER PULLED BACK AND GUIDE WIRE PULLED BACK. GUIDE WIRE FLOATED INTO VESSEL ON ITS OWN. AT THIS POINT, BOTH CATHETER AND GUIDE WIRE REMOVED FROM PATIENT. GUIDE WIRE "COATING" WAS SEVERED. X RAY DONE AND VASCULAR SERVICE CONTACTED FOR FURTHER MANAGEMENT. XRAY SHOWED NO GUIDE WIRE IN PATIENT". SURGERY WAS DELAYED FOR 45 MINUTES. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22771449 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "RA INSERTED AND THEN REMOVED AS THE STEEL CANNULA PART OF THE ART LINE HAS DETACHED. IT HAD FALLEN OFF WHILE STILL PARTIALLY WITHIN THE PLASTIC INTRA- ARTERIAL CANNULA. LUCKILY ENOUGH WAS LEFT THAT THEY WERE ABLE TO GRAB AND REMOVE." 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 22727612 ↗
• MalfunctionJul 8, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT "DURING A PROCEDURE USING THE RA-04020 CATHETER IN THE OPERATING ROOM, THERE WAS NO BLOOD RETURN AFTER PUNCTURE. REPLACED WITH THE NEW PRODUCT." A NEW KIT WAS OPENED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO ADVERSE EVENT REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438838 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED "AFTER SUCCESSFUL CANNULATION OF RADIAL ARTERY CATHETER WAS ADVANCED. BACK PORTION OF NEEDLE WAS REMOVED BUT THIS ONLY REMOVED THE WIRE LEAVING THE NEEDLE IN PATIENT. THIS WAS REMOVED AND CATHETER HAD TO BE REPLACED." 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 22300607 ↗
• MalfunctionJun 13, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "DURING A PROCEDURE USING THE RA-04020 CATHETER IN THE OPERATING ROOM, THERE WAS NO BLOOD RETURN AFTER PUNCTURE." A NEW KIT WAS USED TO RESOLVE THE ISSUE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22201884 ↗
• InjuryFeb 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE INSERTION WAS SUCCESSFUL WITH FLASHBACK. THE GUIDEWIRE ADVANCED WITHOUT ISSUE. HOWEVER, WHEN ATTEMPTING TO REMOVE THE DEVICE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE GUIDEWIRE COULD NOT BE RETRACTED, AND THE CATHETER NEEDLE COULD NOT BE REMOVED. THE MDA CAME TO REMOVE THE ENTIRE DEVICE AND DISCOVERED THAT THE CATHETER TIP HAD BEEN SHEARED OFF. A FOREIGN BODY WAS VISIBLE ON ULTRASOUND. THE CATHETER WAS REMOVED VIA SURGICAL CUTDOWN BY VASCULAR SURGERY. THE PATIENT IS FINE AND HAD NO HARM OR INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21432641 ↗
• MalfunctionFeb 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "ANAETHETIST INSERTING ARTERIAL CATHETER HAD 2 FAILED ATTEMPTS WITH NO EVIDENCE OF FLASH BACK SEEN. ON REMOVAL STRONG BRIGHT BLOOD FLOW INDICATING WAS IN THE ARTERY ON BOTH OCCASIONS". A NEW KIT WAS USED TO RESOLVE THE ISSUE. THE PATIENT IS FINE AND HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00143 AND 9680794-2025-00142.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344543 ↗
• MalfunctionFeb 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED, "ANAETHETIST INSERTING ARTERIAL CATHETER HAD 2 FAILED ATTEMPTS WITH NO EVIDENCE OF FLASH BACK SEEN. ON REMOVAL STRONG BRIGHT BLOOD FLOW INDICATING WAS IN THE ARTERY ON BOTH OCCASIONS". A NEW KIT WAS USED TO RESOLVE THE ISSUE. THE PATIENT IS FINE AND HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00143 AND 9680794-2025-00142.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21344523 ↗
• MalfunctionJan 9, 2025Difficult to Remove; Failure to Advance; No Flow; Difficult to Remove; Failure to Advance; No Flow

  IT WAS REPORTED "BLOOD WAS NOT ABLE TO FLASH BACK. ALSO, WOULD NOT ALLOW THE WIRE TO ADVANCE. AND THEN HAD TROUBLE GETTING THE NEEDLE AND WIRE TO COME OUT OF THE PATIENT'S ARM." THE CUSTOMER REPORTED THIS EVENT HAS OCCURED SEVERAL TIMES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2024-01234, 9680794-2024-01254 AND 9680794-2025-00043.

  Patient problems: Insufficient Information

  MAUDE report 21112717 ↗
• MalfunctionJan 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO A-LINE ARROWS BENT UPON INSERTION INTO THE PATIENT DURING THE PROCEDURE. THE PATIENT CONDITION WAS REPORTED AS "UNKNOWN". ASSOCIATED MDR#: 9680794-2025-00023.

  Patient problems: Insufficient Information

  MAUDE report 21090849 ↗
• MalfunctionJan 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO A-LINE ARROWS BENT UPON INSERTION INTO THE PATIENT DURING THE PROCEDURE. THE PATIENT CONDITION WAS REPORTED AS "UNKNOWN". ASSOCIATED MDR#: 9680794-2025-00024.

  Patient problems: Insufficient Information

  MAUDE report 21090731 ↗
• MalfunctionDec 26, 2024Difficult to Remove; Obstruction of Flow; Failure to Advance; Material Twisted/Bent; Difficult to Remove; Obstruction of Flow; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT 'THE DEVICE WAS NOT ALLOWING BLOOD TO FLASH BACK. ALSO, THE WIRE COULD NOT BE ADVANCED, AND THEN HAD TROUBLE GETTING THE NEEDLE AND WIRE TO COME OUT OF THE PATIENT'S ARM'. THE ISSUE HAD OCCURRED SEVERAL TIMES AND NO PATIENT INJURIES WERE NOTED. THE CATHETERS WERE REPLACED TO RESOLVE THE ISSUE. NO PATIENT INJURY OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019626 ↗
• MalfunctionDec 17, 2024Difficult to Remove; Obstruction of Flow; Failure to Advance; Difficult to Remove; Obstruction of Flow; Failure to Advance

  IT WAS REPORTED, "REFERENCE NUMBER (B)(4) IS NOT ALLOWING A BLOOD TO FLASH BACK. ALSO, WOULD NOT ALLOW THE WIRE TO ADVANCE. AND THEN HAD TROUBLE GETTING THE NEEDLE AND WIRE TO COME OUT OF THE PATIENT'S ARM." THE CUSTOMER REPORTED THIS EVENT HAS OCCURED SEVERAL TIMES. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-01234 AND 9680794-2024-01254.

  Patient problems: Insufficient Information

  MAUDE report 20951584 ↗
• MalfunctionDec 12, 2024Difficult to Remove; Obstruction of Flow; Failure to Advance; Material Twisted/Bent; Difficult to Remove; Obstruction of Flow; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED "IS NOT ALLOWING A BLOOD TO FLASH BACK. ALSO, WOULD NOT ALLOW THE WIRE TO ADVANCE. AND THEN HAD TROUBLE GETTING THE NEEDLE AND WIRE TO COME OUT OF THE PATIENT'S ARM." ADDITIONAL INFORMATION RECEIVED REPORTS "THE WIRE WHEN PULLED OUT HAD A Z IN IT ONE TIME". THE ARTERIAL CATHETER WAS REMOVED AND ANOTHER LINE WAS PLACED. 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 20912823 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K810675. One submission often covers many models, so check the product and lot details in each record.

• Z-2397-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18
• Z-3299-2024 · Jul 26, 2024 · Open, Classified
  Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray
• Z-0844-2020 · Dec 12, 2019 · Open, Classified
  Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-1330-2018 · Dec 22, 2017 · Terminated
  (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Fea
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220
• Z-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018
• Z-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C

…and 17 more.