ARROW IPN036984Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 50801902117644), received between Aug 30, 2021 and Mar 16, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 reports).

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

31 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.

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-2397-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "GUIDEWIRE ISSUES (GRIPPING AND FLEXIBILITY), KINKING, AND ISSUES WITH INSERTION." THE CATHETER WAS NOT PLACED DUE TO THE WIRE KINKING. THERE WAS A DELAY IN CARE. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24607579 ↗
• MalfunctionJan 23, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "I WANTED TO INFORM YOU THAT WE ENCOUNTERED A DEFECTIVE SPRING WIRE GUIDE IN ONE OF YOUR ARTERIAL CATHETERIZATION KITS ON SATURDAY, (B)(6) 2025, IN THE EMERGENCY DEPARTMENT AT (B)(6)." ADDITIONAL INFORMATION RECEIVED STATES "THE SPRING WIRE GUIDE WAS KINKED, CAUSING THE WIRE TO EXIT THROUGH THE SIDE WHEN ADVANCED." THERE WAS A DELAY IN GETTING AN ART LINE. THE PATIENT WAS ADMITTED TO ANOTHER FLOOR.

  Patient problems: Insufficient Information

  MAUDE report 24162155 ↗
• MalfunctionJun 25, 2025Material Frayed; Failure to Advance; Material Frayed; Failure to Advance

  IT WAS REPORTED "ONCE WE HAVE ACCESS TO THE VESSEL, WE THREAD THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE. THEN, WE REMOVE THE INTRODUCER NEEDLE AND RUN THE CATHETER OVER THE GUIDEWIRE WITHIN THE FEMORAL ARTERY. UNFORTUNATELY, WE HAVE NOT BEEN ABLE TO ADVANCE THE FEMORAL ARTERIAL CATHETER OVER THE GUIDEWIRE PAST 0.5-1CM. SOME FEMORAL ARTERIAL CATHETERS NARROW SIGNIFICANTLY OR KINK AT AROUND 0.5 - 1CM, SO THAT WE CANNOT ADVANCE THE CATHETER OVER THE GUIDEWIRE INTO THE FEMORAL ARTERY." ADDITIONAL INFORMATION RECEIVED STATES "ALL COMPONENTS REMOVED FROM PATIENT WITH WIRE VISIBLY FRAYED BUT NOT WITHIN PATIENT." IT WAS REPORTED THERE WAS NO OVERT HARM TO THE PATIENT, POTENTIAL BLOOD LOSS FROM WIRE FAILURE AND PRESSURE APPLIED GROIN". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED" DUE TO UNRELATED ISSUES. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00525, 9680794-2025-00524, AND 9680794-2025-00521.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22328321 ↗
• MalfunctionJun 23, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED "ONCE WE HAVE ACCESS TO THE VESSEL, WE THREAD THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE. THEN, WE REMOVE THE INTRODUCER NEEDLE AND RUN THE CATHETER OVER THE GUIDEWIRE WITHIN THE FEMORAL ARTERY. UNFORTUNATELY, WE HAVE NOT BEEN ABLE TO ADVANCE THE FEMORAL ARTERIAL CATHETER OVER THE GUIDEWIRE PAST 0.5-1CM. SOME FEMORAL ARTERIAL CATHETERS NARROW SIGNIFICANTLY OR KINK AT AROUND 0.5 - 1CM, SO THAT WE CANNOT ADVANCE THE CATHETER OVER THE GUIDEWIRE INTO THE FEMORAL ARTERY." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00525, . 9680794-2025-00523, AND 9680794-2025-00521.

  Patient problems: Insufficient Information

  MAUDE report 22309776 ↗
• MalfunctionJun 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ATTEMPTED TO PLACE RIGHT FEMORAL GROIN ARTERIAL LINE UTILIZING ARROW ARTERIAL CATHETERIZATION 18-GAUGE KIT. ACCESS WAS OBTAINED UNDER ULTRASOUND GUIDANCE BUT UNABLE TO THREAD CATHETER OVER A WIRE. UPON REMOVAL OF CATHETER AND WIRE DISTAL TIP OF WIRE WAS NOTED TO BE BUNCHED AND THERE WAS A KINK AND WIRE APPROXIMATELY AT MIDPOINT. PATIENT REQUIRED SECOND ATTEMPT AT FEMORAL A-LINE ACCESS. WAS ABLE TO SUCCESSFULLY PLACE SECOND FEMORAL ACCESS KIT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22202679 ↗
• MalfunctionMay 8, 2025Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance

  IT WAS REPORTED "TONIGHT WE HAD MULTIPLE ATTEMPTS INSERTING A FEMORAL ARTERIAL LINE WITH PATIENT IN 1111(MB). WHILE ATTEMPTING TO PLACE THIS LINE, WE EXPERIENCED ISSUES THREADING THE WIRE ( IT GOT STUCK AS WE TRIED TO ADVANCE THE WIRE BEYOND THE NEEDLE) AND DURING ONE ATTEMPT THE WIRE EVEN UNRAVELED WHILE TRYING TO PULL THE WIRE OUT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL QUESTIONS WERE REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21986064 ↗
• MalfunctionMay 8, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED "ATTEMPTED TO PLACE RIGHT FEMORAL GROIN ARTERIAL LINE UTILIZING ARROW ARTERIAL CATHETERIZATION 18-GAUGE KIT. ACCESS WAS OBTAINED UNDER ULTRASOUND GUIDANCE BUT UNABLE TO THREAD CATHETER OVER A WIRE. UPON REMOVAL OF CATHETER AND WIRE DISTAL TIP OF WIRE WAS NOTED TO BE BUNCHED AND THERE WAS A KINK AND WIRE APPROXIMATELY AT MIDPOINT. PATIENT REQUIRED SECOND ATTEMPT AT FEMORAL A-LINE ACCESS. WAS ABLE TO SUCCESSFULLY PLACE SECOND FEMORAL ACCESS KIT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 21985960 ↗
• MalfunctionMar 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE WIRE WAS UNABLE TO BE WITHDRAWN FROM THE CATHETER AND WAS CURLING. THE WIRE WAS REMOVED IN ITS ENTIRETY AND A NEW CATHETER WAS PLACED IN THE SAME SITE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663270 ↗
• MalfunctionMar 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SWG KINKED PRIOR TO THE PATIENT INSERTION. ANOTHER KIT WAS OPENED TO START THE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558453 ↗
• MalfunctionFeb 27, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE CATHETER HAS A CRIMP TOWARDS THE END NEAR THE TIP AND THE TIP ITSELF IS CRIMPED, WOULD NOT ALLOW WIRE TO PASS THROUGH, HAD TO OPEN SECOND KIT". THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00194.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21477209 ↗
• MalfunctionJan 29, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE NEEDLE AND WIRE IN THE ARTERIAL KIT. ADDITIONAL INFORMATION FROM THE CLINICAL STAFF INDICATED THAT PULSATILE BLOOD FLOW WAS OBSERVED UPON NEEDLE INSERTION; AND RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE WIRE. AN ATTEMPT WAS MADE TO RETRACT THE WIRE TO CHECK BLOOD FLOW, BUT THE WIRE WOULD NOT RETRACT. AS A RESULT, BOTH THE NEEDLE AND WIRE WERE REMOVED TOGETHER. THE BEVEL WAS UP DURING WIRE INSERTION, AND THE WIRE WAS REMOVED INTACT BUT BENT. THERE WAS NO HARM OR CONSEQUENCES TO THE PATIENT, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT LATER PASSED AWAY, AND THE DEATH WAS UNRELATED TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265041 ↗
• InjuryJan 10, 2025Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE LEFT FEMORAL ARTERIAL LINE PLACEMENT, DIFFICULTY WAS ENCOUNTERED TO PULL THE WIRE BACK THROUGH THE NEEDLE. THE WIRE AND NEEDLE WERE REMOVED TOGETHER, AND WIRE SHEARED AT THE TIP. THE FRACTURED WIRE WAS RETRIEVED BY INTERVENTIONAL RADIOLOGY. THE PATIENT WAS FINE AND HAD NO HARM OR INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21124836 ↗
• MalfunctionOct 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "CATHETER WAS CRUSHED". A NEW KIT WAS USED TO FINISH 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 20459560 ↗
• MalfunctionOct 2, 2024Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED "THERE WAS AN ISSUE WITH THE WIRE AND CATHETER." ADDITIONAL INFORMATION REPORTS "WHEN HE WENT TO THREAD THE CATHETER OVER THE WIRE, HE KEPT MEETING RESISTANCE ONCE THE CATHETER WENT THROUGH THE SKIN OVER THE GUIDEWIRE. HE COULDN'T GET THE TIP OF THE CATHETER INTO THE ARTERY. HE DID A MINIMAL SKIN KNICK TO HELP WITH ADVANCEMENT, BUT THE CATHETER STILL WOULDN'T GO, AND IT STARTED TO BUCKLE ON ITSELF." THE PATIENT WAS ABLE TO GET A RADIAL LINE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL" AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20350474 ↗
• MalfunctionMay 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "CATHETER IN KIT WAS CRUSHED FLATTENED NEAR THE TIP OF THE CATHETER." 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 19260426 ↗
• MalfunctionSep 1, 2023Material Separation; Unraveled Material; Physical Resistance/Sticking; Material Separation; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THE SPRING WIRE HAD UNCOILED AFTER ADVANCING THROUGH THE NEEDLE. THE NEEDLE AND WIRE WERE REMOVED TOGETHER WITH EVERYTHING INTACT AND ANOTHER KIT WAS USED FOR THE INSERTION. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. ADDITIONAL INFORMATION RECEIVED 24AUG2023 REPORTED "THE INSERTING PROVIDER MENTIONED FEELING SOMETHING KINK UP IN THE CATHETER DURING HER ATTEMPTS TO WITHDRAW THE GUIDEWIRE (AND PRIOR TO IT UNRAVELING)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670674 ↗
• InjuryMay 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THE PRODUCT WAS BEING REMOVED AS THERAPY WAS DONE. THE NURSE PULLED THE HUB FROM CATHETER BODY AND THE BODY "LODGED IN THE VEIN". THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY AND THE CATHETER WAS SUCCESSFULLY REMOVED. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14272942 ↗
• MalfunctionFeb 25, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE INSERTER WAS UNABLE TO INSERT LINE DUE TO CATHETER BUCKLING AND HAD TO OPEN A SECOND KIT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13607850 ↗
• MalfunctionNov 9, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTS ARTERIAL LINE FAILURE IN THE ICU. THREE KITS HAD TO BE OPENED TO PLACE ONE CATHETER. ALL THREE CATHETERS WERE KINKED. THE PHYSICIAN COULD NOT PASS THE WIRE THROUGH THE CATHETER. HE STRUGGLED AND WAS ABLE TO GET THE WIRE PASS IN THE THIRD (LAST) ATTEMPT. THERE WAS NO PATIENT INJURY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779013 ↗
• MalfunctionNov 9, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTS ARTERIAL LINE FAILURE IN THE ICU. THREE KITS HAD TO BE OPENED TO PLACE ONE CATHETER. ALL THREE CATHETERS WERE KINKED. THE PHYSICIAN COULD NOT PASS THE WIRE THROUGH THE CATHETER. HE STRUGGLED AND WAS ABLE TO GET THE WIRE PASS IN THE THIRD (LAST) ATTEMPT. THERE WAS NO PATIENT INJURY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778977 ↗
• MalfunctionNov 9, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  CUSTOMER REPORTS ARTERIAL LINE FAILURE IN THE ICU. THREE KITS HAD TO BE OPENED TO PLACE ONE CATHETER. ALL THREE CATHETERS WERE KINKED. THE PHYSICIAN COULD NOT PASS THE WIRE THROUGH THE CATHETER. HE STRUGGLED AND WAS ABLE TO GET THE WIRE PASS IN THE THIRD (LAST) ATTEMPT. THERE WAS NO PATIENT INJURY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778955 ↗
• MalfunctionAug 30, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: THE GUIDEWIRE BENT AND FRAYED. THE INSERTER OPENED ANOTHER KIT AND THE SAME THING HAPPENED. TWO KITS USED ON SAME PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388492 ↗
• MalfunctionAug 30, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: THE GUIDEWIRE BENT AND FRAYED. THE INSERTER OPENED ANOTHER KIT AND THE SAME THING HAPPENED. TWO KITS USED ON SAME PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388459 ↗

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-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-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• 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-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• Z-1281-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04018
• Z-1284-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04120
• Z-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020

…and 16 more.