ARROW IPN037062Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20801902121688), received between Feb 19, 2021 and Jul 14, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Separation; Material Separation

  IT WAS REPORTED "ARTERIAL LINE CATHETER WAS PLACED, & DEEMED UNSUCCESSFUL, AS IT WAS NOT FUNCTIONING PROPERLY, & NEEDED TO BE REMOVED. ARTERIAL LINE CATHETER TIP BROKE OFF FROM THE HUB PORTION, PARTIALLY INSIDE THE PATIENT, DURING THE REMOVAL PROCEDURE, EVEN THOUGH NO RESISTANCE WAS REPORTED. THE INSERTING MD MADE AN INCISION AND EXCISED THE RETAINED CATHETER BODY FROM THE PATIENT WITHOUT INCIDENT. A SECOND ARTERIAL LINE WAS PLACED WITHOUT INCIDENT & WAS FUNCTIONING AS NEEDED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494737 ↗
• MalfunctionFeb 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER.". ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00153, 9680794-2025-00158, 9680794-2025-00164, 9680794-2025-00163, 9680794-2025-00162, 9680794-2025-00161, 9680794-2025-00160 AND 9680794-2025-00157.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409792 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER.". ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00153, 9680794-2025-00158, 9680794-2025-00164, 9680794-2025-00163, 9680794-2025-00162, 9680794-2025-00161, 9680794-2025-00159 AND 9680794-2025-00157.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409767 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER.". ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409723 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER.". ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409706 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER." ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409698 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER.". ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00153, 9680794-2025-00158, 9680794-2025-00163, 9680794-2025-00162, 9680794-2025-00161, 9680794-2025-00160, 9680794-2025-00159 AND 9680794-2025-00157.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409693 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER." ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409691 ↗
• MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER.". ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409687 ↗
• MalfunctionFeb 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "IT HAS COME TO MY ATTENTION THAT THIS LOT IS FAULTY. THE PHYSICIAN ATTEMPTED TO USE SIX KITS, AND ALL RESULTED IN THE ISSUE: THE GUIDEWIRE WHEN PULLED OUT, PULLS OUT THE WHOLE CATHETER.". ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT MULTIPLE ATTEMPTS WERE MADE ON VARIOUS ARTERIAL LINES, INCLUDING AXILLARY, FEMORAL, AND RADIAL, BUT THE GUIDEWIRE COULD NOT BE THREADED. INITIALLY, IT WAS THOUGHT THAT THIS ISSUE WAS DUE TO THE PATIENT HAVING PERIPHERAL ARTERY DISEASE (PAD); HOWEVER, THE PROBLEM HAS OCCURRED WITH NUMEROUS PATIENTS. IN CASES WHERE THE GUIDEWIRE WAS SUCCESSFULLY THREADED, IT COULD NOT BE REMOVED, AS IT BECAME STUCK IN THE PATIENT. ADDITIONALLY, THE GUIDEWIRE WOULD GET STUCK IN THE ARTERY ALONG WITH THE NEEDLE, AND UPON REMOVAL, IT WAS CONSISTENTLY FOUND TO BE BENT. THERE HAVE BEEN NO REPORTED MEDICAL CONDITIONS OR INTERVENTIONS RESULTING FROM THE USE OF THESE KITS. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00153, 9680794-2025-00158, 9680794-2025-00164, 9680794-2025-00163, 9680794-2025-00162, 9680794-2025-00161, 9680794-2025-00160, 9680794-2025-00159 AND 9680794-2025-00157.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409684 ↗
• MalfunctionJan 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED AN ISSUE WITH THE GUIDEWIRE WHILE PLACING A FEMORAL ARTERIAL LINE, WHICH WAS BEING USED TO MONITOR PRESSURE. A TOTAL OF FOUR KITS WERE REQUIRED TO SUCCESSFULLY COMPLETE THE LINE INSERTION. THE GUIDEWIRES IN THE FIRST THREE KITS KINKED AND WOULD NOT ADVANCE TO COMPLETE THE INSERTION. ADDITIONALLY, THE GUIDEWIRE IN THE THIRD KIT WOULD NEITHER ADVANCE NOR RETRACT. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00041, 9680794-2025-00040.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21195456 ↗
• MalfunctionJan 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED AN ISSUE WITH THE GUIDEWIRE WHILE PLACING A FEMORAL ARTERIAL LINE, WHICH WAS BEING USED TO MONITOR PRESSURE. A TOTAL OF FOUR KITS WERE REQUIRED TO SUCCESSFULLY COMPLETE THE LINE INSERTION. THE GUIDEWIRES IN THE FIRST THREE KITS KINKED AND WOULD NOT ADVANCE TO COMPLETE THE INSERTION. ADDITIONALLY, THE GUIDEWIRE IN THE THIRD KIT WOULD NEITHER ADVANCE NOR RETRACT. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00041, 9680794-2025-00040 AND 9680794-2025-00042.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21195451 ↗
• MalfunctionJan 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED AN ISSUE WITH THE GUIDEWIRE WHILE PLACING A FEMORAL ARTERIAL LINE, WHICH WAS BEING USED TO MONITOR PRESSURE. A TOTAL OF FOUR KITS WERE REQUIRED TO SUCCESSFULLY COMPLETE THE LINE INSERTION. THE GUIDEWIRES IN THE FIRST THREE KITS KINKED AND WOULD NOT ADVANCE TO COMPLETE THE INSERTION. ADDITIONALLY, THE GUIDEWIRE IN THE THIRD KIT WOULD NEITHER ADVANCE NOR RETRACT. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00041, 9680794-2025-00040 AND 9680794-2025-00042.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21195443 ↗
• MalfunctionDec 6, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "ARTERIAL LINE GUIDEWIRE MALFUNCTION. GUIDEWIRE STRIPPED OF METAL WITHIN NEEDLE CAUSED A KINK IN WIRE, UNABLE TO REMOVE WIRE FROM NEEDLE CAUSED FAILED ARTERIAL LINE INSERTION. THERE WAS NO HARM TO THE PATIENT ONLY MINOR MONITORING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864979 ↗
• MalfunctionNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "WHEN THE PHYSICIAN ATTEMPTED TO INSERT IT THE WIRE SPLIT." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, HOWEVER FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20787177 ↗
• MalfunctionMar 13, 2024Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: WIRE COILED IN PATIENT AND A DIFFICULT REMOVAL DURING THE PLACEMENT. X-RAY WAS PERFORMED AFTER TO CONFIRM ALL WAS REMOVED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892746 ↗
• MalfunctionNov 29, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT: PROVIDER WAS PLACING AN ARTLINE THE GUIDEWIRE MET RESISTANCE WHILE ADVANCING, WHEN SLOWLY RETRACTING THE GUIDEWIRE, THE CORE SNAPPED, AND THE WIRE BEGAN TO UNRAVEL WITH APPROX 1.5 INCHES OF GUIDEWIRE INSIDE THE BODY BEYOND THE INSERTION SITE. A HEMOSTAT WAS USED TO REMOVE THE SECTION OF GUIDEWIRE FROM THE PATIENT SUCCESSFULLY INTACT. XRAY WAS PERFORMED TO CONFIRM NO FOREIGN BODY IN PATIENT. PATIENT IS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226045 ↗
• MalfunctionNov 16, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT: INSERTER PLACED WIRE THROUGH NEEDLE AND WAS THEN UNABLE TO REMOVE WIRE BECAUSE IT UNRAVELLED IN THE ARTERIAL VESSEL. ADDITIONAL INFORMATION: THEY WERE ABLE TO OPEN THE INSERTION SITE WITH A SCALPEL AND REMOVE THE WIRE WITHOUT DOING A CUTDOWN. ANOTHER LINE WAS PLACED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147156 ↗
• MalfunctionSep 7, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT: THE GUIDEWIRE GETS STUCK IN THE INTRODUCER. THEY THEN RETRACT THE GUIDEWIRE AND USE THE HARDER SIDE OF THE TIP OR PUT IN ANOTHER LINE. ADDITIONAL INFORMATION: THE GUIDE WIRE WAS FOUND TO BE KINKED UPON REMOVAL. THE INSERTION ATTEMPTS WERE PERFORMED UNDER ULTRASOUND. THERE WAS NO SCAR TISSUE PRESENT AND THERE WERE NO ISSUES ADVANCING THE WIRE IN THE VESSEL. ARTERIAL BLOOD FLOW WAS PRESENT PRIOR TO ADVANCING THE GUIDEWIRE. THE CONSEQUENCE TO THE PATIENT OF THE INCIDENT WAS ARTERIAL HEMATOMA THAT REQUIRES MANUAL PRESSURE. AN INABILITY TO GAIN ACCURATE BLOOD PRESSURE READINGS UNTIL ANOTHER LINE COULD BE PLACED SUCCESSFULLY. THE PATIENT WAS REPORTEDLY IN SEVERE CARDIOGENIC SHOCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT AND WILL BE ADDED TO THE FOLLOW UP REPORT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS CRITICAL BUT STABLE , BUT NOT REPORTED AS A CONSEQUENCE OF THE INCIDENT. THE ISSUE WAS FOUND IN 8 DIFFERENT INCIDENTS WITH 8 DIFFERENT PATIENTS. ADDITIONAL COMPLAINTS ARE ASSOCIATED: (B)(4).

  Patient problems: Hematoma

  MAUDE report 17698333 ↗
• MalfunctionSep 7, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT: THE GUIDEWIRE GETS STUCK IN THE INTRODUCER. THEY THEN RETRACT THE GUIDEWIRE AND USE THE HARDER SIDE OF THE TIP OR PUT IN ANOTHER LINE. ADDITIONAL INFORMATION: THE GUIDE WIRE WAS FOUND TO BE KINKED UPON REMOVAL. THE INSERTION ATTEMPTS WERE PERFORMED UNDER ULTRASOUND. THERE WAS NO SCAR TISSUE PRESENT AND THERE WERE NO ISSUES ADVANCING THE WIRE IN THE VESSEL. ARTERIAL BLOOD FLOW WAS PRESENT PRIOR TO ADVANCING THE GUIDEWIRE. THE CONSEQUENCE TO THE PATIENT OF THE INCIDENT WAS ARTERIAL HEMATOMA THAT REQUIRES MANUAL PRESSURE. AN INABILITY TO GAIN ACCURATE BLOOD PRESSURE READINGS UNTIL ANOTHER LINE COULD BE PLACED SUCCESSFULLY. THE PATIENT WAS REPORTEDLY IN SEVERE CARDIOGENIC SHOCK. THE PATIENT'S CURRENT CONDITION IS REPORTED AS DECEASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT AND WILL BE ADDED TO THE FOLLOW UP REPORT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS DECEASED BUT NOT REPORTED AS A CONSEQUENCE OF THE INCIDENT. THE ISSUE WAS FOUND IN 8 DIFFERENT INCIDENTS WITH 8 DIFFERENT PATIENTS. ADDITIONAL COMPLAINTS ARE ASSOCIATED: (B)(4).

  Patient problems: Hematoma

  MAUDE report 17697510 ↗
• MalfunctionAug 29, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THE SPRING WIRE GUIDE BECAME STUCK IN THE NEEDLE AS SOON AS THE J-TIP PASSED THE BEVEL WHEN ADVANCING THE WIRE. THERE WAS NO PATIENT HARM REPORTED. THE WIRE AND NEEDLE WERE REMOVED TOGETHER AND A NEW CATHETER WAS PLACED AT A DIFFERENT SITE. THE PATIENT'S CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646231 ↗
• MalfunctionAug 10, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  MEDWATCH REPORT RECEIVED: "UNKNOWN AGE - AFTER ACHIEVING ARTERIAL FLOW IN THE LEFT FEMORAL ARTERY WITH AN 18G NEEDLE, THE WIRE WAS INTRODUCED, BUT WHEN ATTEMPTING TO REMOVE THE NEEDLE, THERE WAS A SNAGGING SENSATION OVER THE WIRE, SO THE WIRE WAS THEN ATTEMPTED TO BE REMOVED THROUGH THE NEEDLE WITHOUT SUCCESS, AGAIN WITH A SENSATION OF SNAGGING. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER, AND UPON REMOVING THE MAJORITY OF THE WIRE CAME OUT OF THE PUNCTURE SITE, HOWEVER THE WIRE APPEARED TO HAVE PARTIALLY UNRAVELED, AND METAL THREADS WERE STILL STUCK WITHIN THE VASCULAR PUNCTURE SITE, STILL ATTACHED TO THE WIRE. IT APPEARS THAT THE WIRE SHREDDED SOMEHOW DURING THIS PROCESS, THOUGH THE MECHANISM IS UNCLEAR. WIRES SHOULD BE ABLE TO BE INSERTED AND REMOVED THROUGH THE NEEDLE WITHOUT DAMAGE TO THE WIRE. THE METAL THREADS WERE REMOVED FROM THE VASCULAR ACCESS SITE. THE MAIN CONCERN WAS HOW THE METAL THREADS WERE SHREDDED OFF THE WIRE."

  Patient problems: Insufficient Information

  MAUDE report 17497225 ↗
• MalfunctionJul 25, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED WHILE PLACING A FEMORAL ARTERIAL CATHETER, THE WIRE PASSED THROUGH THE NEEDLE WITHOUT ISSUE AND THE CATHETER ADVANCED OVER THE WIRE WITHOUT DIFFICULTY. WHEN THE USER TRIED TO REMOVE THE WIRE THERE WAS SOME MILD RESISTANCE AND THE WIRE CAME UNCOILED FROM ITSELF. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391924 ↗
• MalfunctionJun 29, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  THE COMPLAINT IS REPORTED AS: "ART LINE WIRE/NEEDLE MALFUNCTIONED. COULD NOT ADVANCE OR WITHDRAW WIRE. FORCED TO WITHDRAW WIRE AND NEEDLE TOGETHER WITH WIRE PARTIALLY DEPLOYED IN PATIENT. AFTER REMOVAL OF BOTH, PHYSICIAN TRIED "HARD" TO REMOVE WIRE, PULLING IT PARTIALLY INTO THE NEEDLE, UNABLE TO REMOVE." ADDITIONAL INFORMATION RECEIVED CLARIFIED THE GUIDEWIRE BECAME STUCK IN THE NEEDLE AND COULD NOT BE REMOVED FROM THE NEEDLE. NO PATIENT HARM WAS REPORTED, THE PATIENT HAD TO BE STUCK A SECOND TIME WITH A NEW NEEDLE. NO REPORT OF REQUIRED INTERVENTION. THE ISSUE WAS RESOLVED BY USING A NEW KIT. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "DEAD". ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225506 ↗
• MalfunctionMay 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTED THE WIRE SHEARED AND WAS FLIMSIER THAN NORMAL. IT WAS REPORTED THERE WAS A DELAY IN THE REMOVAL AND A NEW LINE WAS PLACED. NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831862 ↗

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-1970-2018 · Apr 11, 2018 · Terminated
  Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
• Z-1969-2018 · Apr 11, 2018 · Terminated
  Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
• Z-1968-2018 · Apr 11, 2018 · Terminated
  Radial Arterial Access Kit; Product Code: ASK-04001-BID2
• Z-2019-2018 · Apr 11, 2018 · Terminated
  Arterial Catheterization Kit; Product Code:NA-04550-1A
• 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-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-1283-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04020-C
• Z-1285-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04122
• 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-1286-2018 · Oct 26, 2017 · Terminated
  Radial Artery Catheterization Kit; Model: AK-04220

…and 17 more.