ARROW IPN035915Recalls & reported problems

Summary

The FDA's MAUDE database contains 217 adverse event reports that list this exact device (DI 00801902002754), received between Apr 16, 2018 and Jun 15, 2026 — classified as 10 injuries, 207 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (119 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 217 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2026, DURING PRODUCT PREPARATION FOR AN ARTERIAL CATHETER INSERTION, THE SPRING WIRE GUIDE (SWG)/TUBE ASSEMBLY WERE OBSERVED TO BE KINKED IN A C-SHAPE UPON OPENING THE PACKAGE. THE EVENT OCCURRED PRIOR TO USE ON THE PATIENT, AND THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512461 ↗
• MalfunctionJun 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE INITIAL INSERTION OF AN ARTERIAL CATHETER, BLOOD WAS OBSERVED LEAKING FROM THE SPRING-WIRE GUIDE (SWG)/TUBE ASSEMBLY. THE AFFECTED DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE AND REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491715 ↗
• MalfunctionJun 8, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING INITIAL INSERTION OF AN ARTERIAL CATHETER, RESISTANCE WAS ENCOUNTERED. THE SPRING WIRE GUIDE (SWG) FAILED TO ADVANCE WITHIN THE HUB WHEN THE HANDLE WAS ACTUATED. VISIBLE BENDING OF THE SWG WAS OBSERVED. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RESPONDED TO REQUEST FOR ADDITIONAL INFORMATION REGARDING THE PATIENT'S OUTCOME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25431198 ↗
• MalfunctionJun 1, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2026,"THE ANESTHESIOLOGY DEPARTMENT REPORTED THAT THE SPRING WIRE GUIDE (SWG) COULD NOT PASS THROUGH THE INTRODUCER NEEDLE DURING USE ON THE PATIENT. THE OPERATOR OBSERVED THAT THE SWG WAS KINKED." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348559 ↗
• MalfunctionApr 15, 2026Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT "THE GUIDEWIRE WAS DIFFICULT TO REMOVE AFTER CATHETER INSERTION, AND WAS FOUND TO BE UNRAVELED UPON REMOVAL." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24886273 ↗
• MalfunctionApr 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT "GUIDEWIRE ARE KINKED DURING THE DIAGNOSTIC". THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DOING WELL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886088 ↗
• InjuryMar 11, 2026Material Separation

  IT WAS REPORTED THAT "PATIENT BROUGHT TO OR AND ANESTHESIA WAS PLACING AN A-LINE. WHILE PLACING THE A-LINE, THE GUIDEWIRE WAS SLID BACK. IT WAS NOTED THAT THE GUIDEWIRE UNSPOOLED WHEN REMOVED. ANESTHESIA WAS CONCERNED THAT A PART OF THE GUIDEWIRE DID NOT COME OUT OF THE CATHETER. X-RAY OBTAINED, GENERAL SURGERY CONSULTED, VASCULAR SURGERY CONSULTED. X-RAY SHOWED A PART OF THE GUIDEWIRE IN THE ARM". IT WAS DETERMINED TO LEAVE THE BROKEN PIECE INSIDE THE PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY DUE TO OTHER HEALTH CONCERNS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24567811 ↗
• InjuryFeb 4, 2026Material Separation

  IT WAS REPORTED THAT "PIECE OF NEEDLE BROKE OFF IN PATIENT WRIST". THE PATIENT WAS TRANSFERRED 24 HOURS AFTER THE EVENT AND WILL NO CONSULTATION FOR THE REMAINING PEICE. ADDITIONAL INFORMATION RECEIVED STATES "WHILE PATIENT WAS IN OUR CARE, AFTER INCIDENT, NO ACUTE CONDITION SIGNS OR SYMPTOMS COULD BE ATTRIBUTED TO THE METAL."

  Patient problems: Foreign Body In Patient

  MAUDE report 24257462 ↗
• MalfunctionDec 11, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT (B)(6) 2025, THE ARTERIAL PUNCTURE NEEDLE IS USED IN ANESTHESIOLOGY DEPARTMENT, AND THE SWG WAS FOUND DIFFICULT TO ADVANCE, SO THE PRODUCT NEEDS TO BE REPLACED." THE CUSTOMER CONFIRMED THE ADVANCEMENT DIFFICULTY WAS DUE TO KINKING OF THE DEVICE. 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 23778215 ↗
• MalfunctionNov 19, 2025Defective Component; Defective Component

  IT WAS REPORTED "A DEFECT IN THE GUIDEWIRE WAS FOUND DURING PRE-USE TESTING IN THE ICU." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597119 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PRE-TEST AFTER ASSEMBLY, IT WAS FOUND THAT THE GUIDEWIRE WAS TWISTED/KINKED. THE IFU DOES NOT INCLUDE ANY INSTRUCTION TO PULL THE HANDLE BACK TO ITS ORIGINAL POSITION DURING THE ASSEMBLY OR TRIAL PHASE OF THE NEEDLE HUB AND SPRING-WIRE TUBE". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597100 ↗
• MalfunctionOct 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PRODUCT PREPARATION/PRE-TEST PRIOR TO THE PROCEDURE, IT WAS FOUND THAT THE THE GUIDEWIRE WAS KINKED/TWISTED. IT WAS REPLACED WITH A NEW PRODUCT." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401799 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED "ARTERIAL LINE BROKE INSIDE PATIENT. INCISION MADE TO REMOVE AND WAS SUCCESSFUL. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22883328 ↗
• MalfunctionAug 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDEWIRE WAS FOUND BENT/KINKED NEAR THE HANDLE, DURING THE PRODUCT PREP BEFORE A-LINE PROCEDURE." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776737 ↗
• MalfunctionAug 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PRODUCT PREPARATION PRIOR TO THE A-LINE PROCEDURE, A PRODUCT DEFECT WAS FOUND. THE TIP OF THE CATHETER WAS BENT. A NEW PRODUCT FROM ANOTHER SUPPLIER WAS USED FOR THE PROCEDURE.". ADDITIONAL INFORMATION RECEIVED CLARIFIES THE GUIDEWIRE WAS KINKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773147 ↗
• MalfunctionAug 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE PRODUCT PREPARATION PRIOR TO THE A-LINE PROCEDURE, A PRODUCT DEFECT WAS FOUND - THE TIP OF THE CATHETER WAS BENT. A NEW PRODUCT WAS USED FOR THE PROCEDURE." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772973 ↗
• MalfunctionJul 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "PEDIATRIC ICU REPORTS GUIDEWIRE BENT DURING INSERTION." 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 22674727 ↗
• MalfunctionJul 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "KINK OBSERVED ON THE GUIDE WIRE DURING USE ON THE PATIENT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22438829 ↗
• MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE GUIDEWIRE WAS FOUND BENT/KINKED DURING THE PRODUCT PREP, BEFORE USE ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976270 ↗
• MalfunctionFeb 6, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE NEEDLE CANNULA BENT WHILE BEING INSERTED TO SECURE THE CATHETER PATHWAY, LEADING TO ITS DISCONTINUATION. IT WAS REPLACED WITH A NEW PRODUCT AND USED THEREAFTER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322920 ↗
• MalfunctionJan 15, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT AN EQUIPMENT FAILURE OCCURRED IN THE ED DURING AN ATTEMPT TO PLACE AN ARTERY LINE IN THE PATIENT'S RIGHT ARM. A FLASH OF BLOOD WAS VISUALIZED, AND AN ATTEMPT WAS MADE TO THREAD THE CATHETER THE REST OF THE WAY. RESISTANCE WAS ENCOUNTERED WHEN TRYING TO REMOVE THE NEEDLE FROM THE CATHETER. THE ENTIRE DEVICE WAS THEN REMOVED FROM THE PATIENT'S ARM, AND IT WAS FOUND THAT THE NEEDLE WAS BENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21160049 ↗
• MalfunctionDec 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 'WHEN CHECKING THE APPEARANCE OF THE PRODUCT BEFORE USE, THE GUIDE WIRE AT THE TIP OF THE DEVICE WAS FOUND TO BE BENT. AS A RESULT, THE PRODUCT WAS NOT USED IN THE PROCEDURE. A NEW SET WAS OPENED FOR THE PROCEDURE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20961606 ↗
• MalfunctionDec 17, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE SWG WAS FOUND KINKED WHEN THE USER ATTEMPTED TO USE THE PRODUCT. THEREFORE, A NEW KIT WAS USED TO FINISH THE PROCEDURE. NO DAMAGE WAS NOTED ON THE PACKAGE BEFORE OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20953223 ↗
• MalfunctionNov 21, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT. IT WAS DIFFICULT TO ADVANCE. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754951 ↗
• MalfunctionNov 21, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT. IT WAS DIFFICULT TO ADVANCE. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754939 ↗

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-1971-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Codes: ASK-04020-DH
• Z-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1972-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• 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-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-1282-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020
• Z-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C

…and 17 more.