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ARROW IPN036437 (REF CDC-45703-XP1A)Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Plus(R) Three-Lumen CVC · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This is a Teleflex Arrowg+ard Blue Plus three-lumen central venous catheter set, used for short-term vascular access. Most reports describe the catheter or its guidewire twisting, kinking, fraying or separating — guidewires that bent or broke during insertion and in some cases stayed inside the patient, plus ports that would not flush or caps that came apart. There are 33 reports, 3 injuries and no deaths. One open recall, started April 2026, covers injectable drugs and saline supplied by a company found to have quality issues.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
33
Deaths reported
0
Injuries reported
3
Recalls naming it
1

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 20801902117216), received between Jan 20, 2021 and May 11, 2026 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (14 reports).

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

53 other recalls cover devices cleared under the same FDA submission (K071538); 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.

Reports received per month

Nov 2023: 3 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 8 reportsApr 2024: 4 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

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-2376-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Material Twisted/Bent14
  • Unraveled Material7
  • Material Separation4
  • Deformation Due to Compressive Stress3
  • Physical Resistance/Sticking3
  • Break1
  • Connection Problem1
  • Difficult to Remove1

Patient problems

  • No Clinical Signs, Symptoms or Conditions18
  • Insufficient Information11
  • Foreign Body In Patient2
  • Hematoma1
  • Needle Stick/Puncture1

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 11, 2026Obstruction of Flow; Malposition of Device

    IT WAS REPORTED THAT ON (B)(6) 2026, A TRIPLE LUMEN CATHETER (TLC) WAS INSERTED, AND THE BROWN (DISTAL) INFUSION PORT COULD NOT BE FLUSHED OR ASPIRATED. THE REMAINING TWO LUMENS WERE REPORTED TO BE FUNCTIONAL. IT WAS SUBSEQUENTLY REPORTED THAT THE CATHETER WAS SLIGHTLY MALPOSITIONED; HOWEVER, THE DEVICE REMAINED PARTIALLY FUNCTIONAL. THE CATHETER REMAINS IMPLANTED IN THE PATIENT, WITH INSTRUCTIONS NOT TO USE THE BROWN (DISTAL) LUMEN. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. THE REPORTER INDICATED THAT A SIMILAR ISSUE HAD OCCURRED ONCE PREVIOUSLY OVER AN EIGHT-YEAR PERIOD. ADDITIONALLY, IT WAS REPORTED THAT THE ASSISTING RESIDENT STATED SIMILAR EVENTS HAD OCCURRED TWO OTHER TIMES DURING THE SAME MONTH, RESULTING IN A TOTAL OF THREE REPORTED OCCURRENCES WITHIN ONE MONTH INVOLVING THE SAME DEVICE TYPE. NO PATIENT INJURY OR ADVERSE HEALTH OUTCOME WAS REPORTED IN ASSOCIATION WITH THIS EVENT. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUES, INCLUDING CONFIRMATION OF THE MULTIPLE REPORTED OCCURRENCES AND ASSESSMENT OF ANY PATIENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25135935 ↗
  • MalfunctionFeb 9, 2026Material Twisted/Bent

    IT WAS REPORTED THAT "WE HAVE HAD SEVERAL (AT LEAST 3) OF THE CDC-45703-XP1A THAT HAVE HAD BENT GUIDEWIRES IN THEM AND ARE NOT USABLE. THIS OCCURRED DURING PATIENT CARE. WE WERE INSERTING THE CENTRAL LINE AND HAD EVERYTHING OPEN ON THE STERILE FIELD WHEN IT WAS DISCOVERED. THE TWO OTHER TIMES WERE THE SAME." THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24290608 ↗
  • MalfunctionJan 12, 2026Disconnection

    IT WAS REPORTED THAT "CENTRAL LINE PLACED IN PT ON ARRIVAL. ABOUT AN HOUR AFTER PLACEMENT, BLUE INFUSION PORT BECAME DISCONNECTED AT THE CAP WITH LITTLE FORCE WHEN ATTEMPTING TO WITHDRAW PLUNGER. THIS LEFT THE IV LINE OPEN WITH NOTHING BEING ABLE TO SEAL THE LINE. LINE CLAMPED AND PHYSICIAN NOTIFIED OF DEFECT." 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 24036769 ↗
  • InjuryNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "OUR ER PROVIDER TRIED USING THESE SETS TODAY. THE PROBLEM WAS THE GUIDE WIRE WOULD BEND AND NOT RELEASE. WE HAVE TRIED 3 TIMES AND TO NO AVAIL." THE FIRST TWO GUIDEWIRES WERE ABLE TO BE REMOVED. THE THIRD GUIDEWIRE WAS KINKED AND UNABLE TO BE REMOVED FROM THE PATIENT'S GROIN. THE WIRE REMAINED EMBEDDED. SUCCESSFUL CENTRAL ACCESS WAS UNABLE TO BE OBTAINED ON THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "EXPIRED AND DIED FROM MULTIORGAN FAILURE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00980, 9680794-2025-01010, AND 9680794-2025-00981.

    Patient problems: Insufficient Information

    MAUDE report 23632151 ↗
  • MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "OUR EMERGENCY ROOM PROVIDER TRIED USING THESE SETS TODAY. THE PROBLEM WAS THE GUIDE WIRE WOULD BEND AND NOT RELEASE. WE HAVE TRIED 3 TIMES AND TO NO AVAIL." THE FIRST TWO GUIDEWIRES WERE ABLE TO BE REMOVED. THE THIRD GUIDEWIRE WAS KINKED AND UNABLE TO BE REMOVED FROM THE PATIENT'S GROIN. THE WIRE REMAINED EMBEDDED. SUCCESSFUL CENTRAL ACCESS WAS UNABLE TO BE OBTAINED ON THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "EXPIRED AND DIED FROM MULTIORGAN FAILURE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00980, 9680794-2025-01010, AND 9680794-2025-00981.

    Patient problems: Insufficient Information

    MAUDE report 23631116 ↗
  • InjuryNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "OUR ER PROVIDER TRIED USING THESE SETS TODAY. THE PROBLEM WAS THE GUIDE WIRE WOULD BEND AND NOT RELEASE. WE HAVE TRIED 3 TIMES AND TO NO AVAIL." THE FIRST TWO GUIDEWIRES WERE ABLE TO BE REMOVED. THE THIRD GUIDEWIRE WAS KINKED AND UNABLE TO BE REMOVED FROM THE PATIENT'S GROIN. THE WIRE REMAINED EMBEDDED. SUCCESSFUL CENTRAL ACCESS WAS UNABLE TO BE OBTAINED ON THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "EXPIRED AND DIED FROM MULTIORGAN FAILURE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-01010, AND 9680794-2025-00981.

    Patient problems: Foreign Body In Patient

    MAUDE report 23631041 ↗
  • MalfunctionAug 28, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "EMERGENCY ROOM AT (B)(6) USED A ERGP PACK THAT HAD A DEFECTIVE GUIDEWIRE. GUIDEWIRE KINKED DURING INSERTION. APPARENTLY, THIS HAPPENED ONE OTHER TIME AS WELL." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS COULD NOT BE PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00720 AND 9680794-2025-00721.

    Patient problems: Insufficient Information

    MAUDE report 22912598 ↗
  • MalfunctionMay 9, 2024Break; Material Separation; Break; Material Separation

    IT WAS REPORTED "WE HAD A SITUATION WHERE THE PATIENT WAS GETTING A CENTRAL LINE INSERTED AND THE GUIDE WIRE BROKE DURING INSERTION. THE DOCTOR WAS ABLE TO OBTAIN THE GUIDE WIRE AND WE RECEIVED ANOTHER CENTRAL LINE KIT AND COMPLETE INSERTION OF THE CENTRAL LINE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19279924 ↗
  • MalfunctionApr 24, 2024Connection Problem; Connection Problem

    THE REPORT STATES "THE INTRODUCER NEEDLE SLIDES OFF THE SYRINGE IF GEL OR BLOOD GETS ON IT. THE INTRODUCER NEEDLE DOES NOT STAY STATIONARY WHEN PLACE ON THE SYRINGE." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Patient problems: Insufficient Information

    MAUDE report 19172684 ↗
  • MalfunctionApr 2, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED " DURING INSERTION THE WIRE HAD DIFFICULTY ADVANCING PAST THE NEEDLE TIP. ONCE THE WIRE WAS WITHDRAWN IT HAD KINKED THAT WOULD NOT ADVANCE." IT WAS ORGINALLY REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. NO MEDICAL INTERVENTION REQUIRED AND THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIEVED SAID THE PATIENT'S CURRENT CONDITION IS "EXPIRED". IT IS REPORTED AS "UNKNOWN" IF THE MALFUNCTION CONTRIBUTED TO THE PATIENT'S DEATH AS THE PATIENT WAS 92 WITH RESPIRATORY ISSUES. ASSOCIATED MDR NUMBERS: 9680794-2024-00304, 9680794-2024-00305, AND 9680794-2024-00307.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19018700 ↗
  • MalfunctionApr 2, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED " DURING INSERTION THE WIRE HAD DIFFICULTY ADVANCING PAST THE NEEDLE TIP. ONCE THE WIRE WAS WITHDRAWN IT HAD KINKED THAT WOULD NOT ADVANCE." IT WAS ORGINALLY REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. NO MEDICAL INTERVENTION REQUIRED AND THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIEVED SAID THE PATIENT'S CURRENT CONDITION IS "EXPIRED". IT IS REPORTED AS "UNKNOWN" IF THE MALFUNCTION CONTRIBUTED TO THE PATIENT'S DEATH AS THE PATIENT WAS 92 WITH RESPIRATORG ISSUES. ASSOCIATED MDR NUMBERS: 9680794-2024-00305, 9680794-2024-00306, AND 9680794-2024-00307.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19018649 ↗
  • MalfunctionApr 2, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED " DURING INSERTION THE WIRE HAD DIFFICULTY ADVANCING PAST THE NEEDLE TIP. ONCE THE WIRE WAS WITHDRAWN IT HAD KINKED THAT WOULD NOT ADVANCE." IT WAS ORGINALLY REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. NO MEDICAL INTERVENTION REQUIRED AND THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ADDITIONAL INFORMATION RECEIEVED SAID THE PATIENT'S CURRENT CONDITION IS "EXPIRED". IT IS REPORTED AS "UNKNOWN" IF THE MALFUNCTION CONTRIBUTED TO THE PATIENT'S DEATH AS THE PATIENT WAS 92 WITH RESPIRATORG ISSUES. ASSOCIATED MDR NUMBERS : 9680794-2024-00304, 9680794-2024-00306, AND 9680794-2024-00307.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19018628 ↗
  • MalfunctionMar 29, 2024

    THE INTRODUCER NEEDLE SLIDES OFF THE SYRINGE IF GEL OR BLOOD GETS ON IT. THE INTRODUCER NEEDLE DOES NOT STAY STATIONARY WHEN PLACE ON THE SYRINGE.

    Patient problems: Insufficient Information

    MAUDE report 19003007 ↗
  • MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "PROVIDER STATES THAT THE WIRE HAD DIFFICULTY ADVANCING PAST THE NEEDLE TIP. ONCE WIRE WAS WITHDRAWN IT HAD KINK THAT WOULD NOT ALLOW IT ADVANCE. MULTIPLE KITS WERE USED ALL REPORTED TO HAVE SIMILAR ISSUES WITH THE WIRE." THE CURRENT CONDITION OF THE PATIENT IS "UNKNOWN" AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE 9680794-2024-00337, 9680794-2024-00338, 9680794-2024-00339, AND 9680794-2024-00340.

    Patient problems: Insufficient Information

    MAUDE report 18977947 ↗
  • MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "PROVIDER STATES THAT THE WIRE HAD DIFFICULTY ADVANCING PAST THE NEEDLE TIP. ONCE WIRE WAS WITHDRAWN IT HAD KINK THAT WOULD NOT ALLOW IT ADVANCE. MULTIPLE KITS WERE USED ALL REPORTED TO HAVE SIMILAR ISSUES WITH THE WIRE." THE CURRENT CONDITION OF THE PATIENT IS "UNKNOWN" AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE 9680794-2024-00337, 9680794-2024-00339, AND 9680794-2024-00340.

    Patient problems: Insufficient Information

    MAUDE report 18977926 ↗
  • MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "PROVIDER STATES THAT THE WIRE HAD DIFFICULTY ADVANCING PAST THE NEEDLE TIP. ONCE WIRE WAS WITHDRAWN IT HAD KINK THAT WOULD NOT ALLOW IT ADVANCE. MULTIPLE KITS WERE USED ALL REPORTED TO HAVE SIMILAR ISSUES WITH THE WIRE." THE CURRENT CONDITION OF THE PATIENT IS "UNKNOWN" AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE 9680794-2024-00337, 9680794-2024-00338, 9680794-2024-00339, AND 9680794-2024-00340.

    Patient problems: Insufficient Information

    MAUDE report 18977905 ↗
  • MalfunctionMar 26, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "PROVIDER STATES THAT THE WIRE HAD DIFFICULTY ADVANCING PAST THE NEEDLE TIP. ONCE WIRE WAS WITHDRAWN IT HAD KINK THAT WOULD NOT ALLOW IT ADVANCE. MULTIPLE KITS WERE USED ALL REPORTED TO HAVE SIMILAR ISSUES WITH THE WIRE." THE CURRENT CONDITION OF THE PATIENT IS "UNKNOWN" AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE 9680794-2024-00337, 9680794-2024-00338, 9680794-2024-00339, AND 9680794-2024-00340.

    Patient problems: Insufficient Information

    MAUDE report 18977880 ↗
  • MalfunctionMar 13, 2024Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "SWG KINKED DURING USE". NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-00226, 9680794-2024-00310, 9680794-2024-00227, AND 9680794-2024-00225.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18894674 ↗
  • MalfunctionMar 13, 2024Material Separation; Material Separation

    IT WAS REPORTED "SPRING WIRE GUIDE KINKS EASILY". NO PATIENT HAR OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDE: 9680794-2024-00226, 9680794-2024-00310, AND 9680794-2024-00225.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18893793 ↗
  • MalfunctionMar 13, 2024Unraveled Material; Unraveled Material

    IT WAS REPORTED "SPRING WIRE GUIDE KINKS EASILY". NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURR ENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2024-00310, 9680794-2024-00227, AND 9680794-2024-00225.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18893768 ↗
  • MalfunctionDec 6, 2023Unraveled Material; Unraveled Material

    IT WAS REPORTED THAT: THE WIRE DISINTEGRATED WHEN HANDLED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

    Patient problems: Insufficient Information

    MAUDE report 18274695 ↗
  • MalfunctionDec 1, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

    ON INTRODUCTION OF CENTRAL LINE WIRE, THE WIRE ENCOUNTERED AN OBSTRUCTION AND, ON WITHDRAWING, BECAME STUCK AT THE TIP OF THE INTRODUCER NEEDLE. THE WHOLE UNIT WAS REMOVED WITHOUT ISSUE AND A SECOND ATTEMPT WAS MADE, BUT UNABLE TO PASS AGAIN. ASSOCIATED TO 9680794-2023-00769. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18244551 ↗
  • InjuryNov 29, 2023Difficult to Remove; Difficult to Remove

    IT WAS REPORTED THAT: THE PHYSICIAN HAD DIFFICULTY GETTING THE WIRE IN WITH THE JTIP END. HE PULLED BACK AGAINST RESISTANCE AND CHOSE TO USE THE BACK END OF THE WIRE TO LEAD IN THE RIGHT IJ. HE PROCEEDED TO PUSH AGAINST RESISTANCE BUT STATED THAT HE THOUGHT IT WAS IN, SO HE PROCEEDED TO PUT CATHETER OVER WIRE. STILL FOUND IT DIFFICULT TO PUSH IT IN SO HE PULLED THE WIRE BACK BUT COULD NOT PULL IT OUT OF THE RIJ. AFTER MANY ATTEMPTS, HE DECIDED TO REMOVE THE CATHETER AND CLAMP THE WIRE IN PLACE AT THE BASE OF THE NECK WITH 2 HEMOSTATS. IT WAS ALSO REPORTED THAT THE PATIENT WAS HIGH ACUITY ON ARRIVAL TO ED. HIS PROGNOSIS POOR, CODING BEGAN IN THE FIELD AND WAS REASSUMED IN THE ED. THE WIRE WAS HELD IN PLACE WITH THE HEMOSTATS UNTIL HE WAS SENT TO HIGHER LEVEL HOSPITAL. THE PATIENT DECEASED AT THE HIGHER-LEVEL HOSPITAL. THE CONSEQUENCE OF THE WIRE INCIDENT WAS THAT THE PATIENT HAD TO GET IT SURGICALLY REMOVED.

    Patient problems: Foreign Body In Patient

    MAUDE report 18225739 ↗
  • MalfunctionNov 21, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    IT WAS REPORTED THAT "GUIDE WIRE BENT DURING INSERTION". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18185246 ↗
  • MalfunctionNov 20, 2023Stretched; Stretched

    IT WAS REPORTED THAT "PROXIMAL LUMEN EXTENSION TUBING STRETCHED AND EXPANDED AFTER PATIENT HAD A CT SCAN". ADDITIONAL INFORMATION RECEIVED STATES THAT THE CVC HAS PLACED THE SAME DAY RIGHT BEFORE THE CT SCAN. DURING THE SCAN, CONTRAST WAS INJECTED VIA A HIGH PRESSURE CT SCAN INJECTION. THE OTHER TWO LUMENS ARE PATENT, ABLE TO FLUSH AND INFUSE FLUIDS AND PULL BACK BLOOD. THE LINE WAS REMOVED AND IT WAS DECIDED BY THE DOCTOR TO NOT REPLACE THE LINE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18175571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071538. One submission often covers many models, so check the product and lot details in each record.

  • Z-1914-2026 · Mar 11, 2026 · Open, Classified
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-4
  • Z-2123-2026 · Jan 7, 2026 · Open, Classified
    Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
  • Z-0003-2024 · Aug 10, 2023 · Open, Classified
    Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
  • Z-0002-2024 · Aug 10, 2023 · Open, Classified
    Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
  • Z-0352-2023 · Oct 27, 2022 · Terminated
    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-
  • Z-0351-2023 · Oct 27, 2022 · Terminated
    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
  • Z-1604-2022 · May 25, 2022 · Open, Classified
    TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
  • Z-1990-2018 · Apr 11, 2018 · Terminated
    Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
  • Z-1998-2018 · Apr 11, 2018 · Terminated
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-427
  • Z-1993-2018 · Apr 11, 2018 · Terminated
    Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
  • Z-1989-2018 · Apr 11, 2018 · Terminated
    ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
  • Z-1991-2018 · Apr 11, 2018 · Terminated
    Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM a
  • Z-1996-2018 · Apr 11, 2018 · Terminated
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; P
  • Z-1995-2018 · Apr 11, 2018 · Terminated
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product
  • Z-1980-2018 · Apr 11, 2018 · Terminated
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

…and 38 more.

Other Catheter,intravascular,therapeutic,short-term less than 30 days devices

All Catheter,intravascular,therapeutic,short-term less than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.