ARROW IPN030865 (REF CV-12854)Recalls & reported problems
Teleflex Incorporated · Four-Lumen CVC · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10801902029239), received between Mar 23, 2021 and Jul 7, 2025 — classified as 1 death, 5 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (8 reports).
24 other recalls cover devices cleared under the same FDA submission (K862056); 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
Most reported problems
Device problems
- Material Twisted/Bent8
- Material Separation4
- Obstruction of Flow4
- Physical Resistance/Sticking4
- Material Frayed3
- Material Split, Cut or Torn2
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- High Blood Pressure/ Hypertension4
- Low Blood Pressure/ Hypotension4
- Insufficient Information2
- Anxiety1
- Confusion/ Disorientation1
- Discomfort1
- Embolism/Embolus1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
DeathJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED "AFTER REMOVAL OF THE CENTRAL VENOUS CATHETER (CVC) PLACED IN THE RIGHT SUBCLAVIAN VEIN, THE PATIENT BEGAN TO SHOW CHANGES IN CONSCIOUSNESS AND MYOCLONUS - PROBABLY GAS EMBOLISM. TREATMENT: HYPERBARIC CHAMBER TREATMENT, + VENTILATION INVASIVE MECHANICS + VASOPRESSOR. " THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". ADDITIONAL INFORMATION REPORTS "ROOT CAUSE ANALYSIS WAS CARRIED OUT ON THIS INCIDENT AND THERE WAS NO EVIDENCE OF PROBLEMS WITH THE DEVICE USED, HOWEVER, THE DISTRIBUTOR WAS MADE AWARE OF THE OCCURENCE."
Patient problems: Embolism/Embolus
MAUDE report 22411076 ↗MalfunctionNov 5, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT: "AFTER PULLING OUT, THE DILATATOR IS FRAYED, AND THE WIRE IS BENT. THE PROCEDURE IS PERFORMED WITHOUT SKIN INCISION BECAUSE THEY USE ANTICOAGULANTS WHICH REDUCE THE BLOOD CLOTTING FUNCTION. THESE PATIENTS ARE AWAITING MAJOR CARDIAC SURGERY. THEREFORE, DOCTORS DO NOT WANT THE INJECTION SITE TO BLEED. THEY TRY TO INTRODUCE THE DILATOR GENTLY AND IN A HELICAL MOTION. THEY FEEL THAT THE MATERIAL OF THE DILATOR IS DIFFERENT THAN IT WAS IN THE PAST." ASSOCIATED COMPLAINTS: 3006425876-2024-01069, 3006425876-2024-01061, 3006425876-2024-01062, 3006425876-2024-01068, 3006425876-2024-01063.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608293 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED THAT: "AFTER PULLING OUT, THE DILATATOR IS FRAYED, AND THE WIRE IS BENT. THE PROCEDURE IS PERFORMED WITHOUT SKIN INCISION BECAUSE THEY USE ANTICOAGULANTS WHICH REDUCE THE BLOOD CLOTTING FUNCTION. THESE PATIENTS ARE AWAITING MAJOR CARDIAC SURGERY. THEREFORE, DOCTORS DO NOT WANT THE INJECTION SITE TO BLEED. THEY TRY TO INTRODUCE THE DILATOR GENTLY AND IN A HELICAL MOTION. THEY FEEL THAT THE MATERIAL OF THE DILATOR IS DIFFERENT THAN IT WAS IN THE PAST." ASSOCIATED COMPLAINTS: 3006425876-2024-01069, 3006425876-2024-01061, 3006425876-2024-01062, 3006425876-2024-01068, AND 3006425876-2024-01067.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608173 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED THAT: "AFTER PULLING OUT, THE DILATATOR IS FRAYED, AND THE WIRE IS BENT. THE PROCEDURE IS PERFORMED WITHOUT SKIN INCISION BECAUSE THEY USE ANTICOAGULANTS WHICH REDUCE THE BLOOD CLOTTING FUNCTION. THESE PATIENTS ARE AWAITING MAJOR CARDIAC SURGERY. THEREFORE, DOCTORS DO NOT WANT THE INJECTION SITE TO BLEED. THEY TRY TO INTRODUCE THE DILATOR GENTLY AND IN A HELICAL MOTION. THEY FEEL THAT THE MATERIAL OF THE DILATOR IS DIFFERENT THAN IT WAS IN THE PAST." ASSOCIATED COMPLAINTS: 3006425876-2024-01069, 3006425876-2024-01062, 3006425876-2024-01068, 3006425876-2024-01063 AND 3006425876-2024-01067.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608159 ↗MalfunctionNov 5, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT: "AFTER PULLING OUT, THE DILATATOR IS FRAYED, AND THE WIRE IS BENT. THE PROCEDURE IS PERFORMED WITHOUT SKIN INCISION BECAUSE THEY USE ANTICOAGULANTS WHICH REDUCE THE BLOOD CLOTTING FUNCTION. THESE PATIENTS ARE AWAITING MAJOR CARDIAC SURGERY. THEREFORE, DOCTORS DO NOT WANT THE INJECTION SITE TO BLEED. THEY TRY TO INTRODUCE THE DILATOR GENTLY AND IN A HELICAL MOTION. THEY FEEL THAT THE MATERIAL OF THE DILATOR IS DIFFERENT THAN IT WAS IN THE PAST." ASSOCIATED COMPLAINTS: 3006425876-2024-01069, 3006425876-2024-01061, 3006425876-2024-01062, 3006425876-2024-01068, 3006425876-2024-01063 AND 3006425876-2024-01067.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608143 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED THAT: "AFTER PULLING OUT, THE DILATATOR IS FRAYED, AND THE WIRE IS BENT. THE PROCEDURE IS PERFORMED WITHOUT SKIN INCISION BECAUSE THEY USE ANTICOAGULANTS WHICH REDUCE THE BLOOD CLOTTING FUNCTION. THESE PATIENTS ARE AWAITING MAJOR CARDIAC SURGERY. THEREFORE, DOCTORS DO NOT WANT THE INJECTION SITE TO BLEED. THEY TRY TO INTRODUCE THE DILATOR GENTLY AND IN A HELICAL MOTION. THEY FEEL THAT THE MATERIAL OF THE DILATOR IS DIFFERENT THAN IT WAS IN THE PAST." ASSOCIATED COMPLAINTS: 3006425876-2024-01069, 3006425876-2024-01061, 3006425876-2024-01068, 3006425876-2024-01063 AND 3006425876-2024-01067.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608119 ↗MalfunctionNov 5, 2024Material Frayed; Material Frayed
IT WAS REPORTED THAT: "AFTER PULLING OUT, THE DILATATOR IS FRAYED , AND THE WIRE IS BENT. THE PROCEDURE IS PERFORMED WITHOUT SKIN INCISION BECAUSE THEY USE ANTICOAGULANTS WHICH REDUCE THE BLOOD CLOTTING FUNCTION. THESE PATIENTS ARE AWAITING MAJOR CARDIAC SURGERY. THEREFORE, DOCTORS DO NOT WANT THE INJECTION SITE TO BLEED. THEY TRY TO INTRODUCE THE DILATOR GENTLY AND IN A HELICAL MOTION. THEY FEEL THAT THE MATERIAL OF THE DILATOR IS DIFFERENT THAN IT WAS IN THE PAST." ASSOCIATED COMPLAINTS: 3006425876-2024-01061, 3006425876-2024-01062, 3006425876-2024-01068, 3006425876-2024-01063 AND 3006425876-2024-01067.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20608032 ↗InjuryOct 24, 2024Disconnection; Material Separation; Disconnection; Material Separation
IT WAS REPORTED "ON THE DAY OF THE INCIDENT, THE CENTRAL VENOUS CATHETER'S DISTAL LINE EXTENDER, WHICH HAD BEEN INSERTED ON (B)(6) 2024 AT AROUND 6PM, WAS FOUND DISCONNECTED. THE CONNECTOR CONNECTED TO THE EXTENSION LINE WAS FOUND BROKEN ON THE FLOOR. THE TEAM OBSERVED THAT THERE WAS NO BLOOD ON THE FLOOR OR SHEETS AND PERFORMED AN EMERGENCY PURGE OF 10 ML OF AIR AND CLAMPED. DUE TO MODERATE SYMPTOMS, THERE WAS A SUSPICION OF GAS EMBOLISM. DESATURATION 86% AND SYSTOLIC ARTERIAL HYPERTENSION 220 MM HG. TREATMENT WITH HYPERBARIC OXYGEN THERAPY. NO FURTHER CONSEQUENCE AFTER THE INCIDENT. THE PATIENT MAY HAVE STAYED ABOUT 30 MINUTES WITH THE EXTENSION LINE DISCONNECTED. THE PATIENT BECAME ANXIOUS FOLLOWING THIS EPISODE. THE CENTRAL VENOUS LINE IS STILL IN PLACE, THE EXTENSION LINE WAS DISCARDED." THE PATIENT RETURNED TO NORMAL HEMODYNAMICS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Anxiety; High Blood Pressure/ Hypertension; Low Oxygen Saturation
MAUDE report 20522152 ↗MalfunctionJul 17, 2024Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn
IT WAS REPORTED "IN THE LAST 2 MONTHS, WHEN INSERTING THE CVC, DOCTORS HAVE NOTICED THAT THE DILATOR SPLITS DURING THE INSERTION OF THE DILATOR AND THIS LEADS TO DIFFICULT MANIPULATION OF THE LEAD, SOMETIMES EVEN BREAKING IT." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19760505 ↗MalfunctionJul 11, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
IT WAS REPORTED "IN THE LAST 2 MONTHS, WHEN INSERTING THE CVC, DOCTORS HAVE NOTICED THAT THE DILATOR SPLITS DURING THE INSERTION OF THE DILATOR AND THIS LEADS TO DIFFICULT MANIPULATION OF THE LEAD, SOMETIMES EVEN BREAKING IT." 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 19722240 ↗InjuryJun 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ONE EXTENSION LINE WAS BENT, WHICH PREVENTED 1 LITRE OF HYDRATION INFUSION FROM PASSING THROUGH BECAUSE IT WAS FLOW-CONTROLLED BY DIALAFLOW. THE CLINICAL CONSEQUENCE INCLUDED HYPERNATREMIA AND NEUROLOGICAL PROBLEMS." THE PATIENT HAD TO BE REHYDRATED WITH SODIUM CHLORIDE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Confusion/ Disorientation; Hypernatremia; Lethargy
MAUDE report 19469186 ↗InjuryMay 17, 2024Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent
IT WAS REPORTED THAT "PROXIMAL EXTENSION LINE KINKED, WITH NORADRENALINE PLUGGED ON IT. BOLUS OF NOREPINEPHRINE WITH HYPERTENSION WHEN THE LINE WAS UNKINKED." ADDITIONAL INFORMATION REPORTS "THE REPLACEMENT OF THE DEVICE WAS SUCCESSFULLY CHANGED ON (B)(6)2024" THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 19340312 ↗MalfunctionApr 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "THE PROXIMAL TUBING OF THE CENTRAL LINE, CLOSE TO THE PATIENT, KINKED. NORADRENALINE WAS BEING ADMINISTERED, WHICH CAUSED ARTERIAL HYPOTENSION FOR A TIME. AFTER A FEW MINUTES, THE SYRINGE PUMP STARTED BEEPING. AFTER INVESTIGATING, WE REALISED WHEN HANDLING THE CATHETER THAT IT WAS KINKED. WHEN WE UN-KINKED IT, A BOLUS OF NAD WAS ADMINISTERED, WITH SEVERE HYPERTENSION." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".
Patient problems: Insufficient Information
MAUDE report 19214990 ↗InjuryApr 30, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "THE PROXIMAL TUBING OF THE CENTRAL LINE, CLOSE TO THE PATIENT, KINKED. NORADRENALINE WAS BEING ADMINISTERED, WHICH CAUSED ARTERIAL HYPOTENSION FOR A TIME. AFTER A FEW MINUTES, THE SYRINGE PUMP STARTED BEEPING. AFTER INVESTIGATING, WE REALISED WHEN HANDLING THE CATHETER THAT IT WAS KINKED. WHEN WE UN-KINKED IT, A BOLUS OF NAD WAS ADMINISTERED, WITH SEVERE HYPERTENSION." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".
Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension
MAUDE report 19214980 ↗MalfunctionApr 8, 2024Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent
IT WAS REPORTED "AN EXTENSION LINE TWISTED, AND IT'S BLOCKING THE GOOD FLOW OF THE MEDICATION WHEN USING THE SYRINGE THERE IS SUPPRESSION AND DOESN'T DELIVER THE MEDICATION AS IT SHOULD. THE PATIENT DOES NOT RECEIVE THE MEDICATION AS HE SHOULD, CAUSING AN INCREASE IN BLOOD PRESSURE ON THE PATIENT. THE EXTENSION LINE IS BENT TO TRY TO REMOVE THE TWISTED PART." ADDITIONAL INFORMATION REPORTS "DURING THE INCIDENT THE PATIENT'S BLOOD PRESSURE DROPPED BECAUSE THE DEVICE WAS NO LONGER DELIVERING THE DRUG PROPERLY. THE PROBLEM WAS SOLVED BY TURNING THE LINE UPSIDE DOWN TO REMOVE THE TWISTED PART." THE PATIENT'S CURRENT STATUS IS UNKNOWN AT THIS TIME.
Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension
MAUDE report 19058954 ↗MalfunctionFeb 23, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED "SEVERAL PATIENTS WERE INVOLVED IN SIMILAR INCIDENTS WHERE NON-ADMINISTRATION OF NOREPINEPHRINE, LINKED TO OBSTRUCTION OF THE CATHETER'S SIDE EYES BY CLOT FORMATION, LED TO SIGNIFICANT VARIATIONS IN BLOOD PRESSURE IN THE PATIENTS CONCERNED. ADDITIONAL INFORMATION REPORTS, "TO SOLVE THE PROBLEM, WE FIRST SWAPPED THE NORADRENALINE ON THE DISTAL LINE, THEN CHANGED THE CATHETER IN A SECOND STEP. THE 2ND KIT WAS INSERTED WITH NO PROBLEM". THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE WITH THE "PATIENT OUT OF THE DEPARTMENT". ASSOCIATED MDR NUMBER 3006425876-2024-00170.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 18767792 ↗MalfunctionFeb 23, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED "WHILE USING THE DEVICE TO INFUSE NOREPINEPHRINE VIA THE PROXIMAL LINE, IT WAS OBSERVED THAT THE SIDE EYES ALONG THE CATHETER BECAME BLOCKED DUE TO THE FORMATION OF BLOOD CLOTS. THIS PREVENTED THE ADMINISTRATION OF NOREPINEPHRINE". ADDITIONAL INFORMATION REPORTS, "TO SOLVE THE PROBLEM, WE FIRST SWAPPED THE NORADRENALINE ON THE DISTAL LINE, THEN CHANGED THE CATHETER IN A SECOND STEP. THE 2ND KIT WAS INSERTED WITH NO PROBLEM". ASSOCIATED MDR NUMBER 3006425876-2024-00169.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 18767775 ↗MalfunctionJan 5, 2024Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking
IT WAS REPORTED THAT: UNABLE TO REMOVE THE SWG FROM THE CATHETER DURING INSERTION, WHEN REMOVING IT THE DOCTOR OBSERVED THE SWG UNRAVELING LIKE A SPRING, AFTER REMOVING IT, THE CATHETER INSERTION COULD NOT BE FINALISED. ANOTHER SITE WAS USED TO INSERT ANOTHER CATHETER. THIS CAUSED A DELAY AND DISCOMFORT FOR THE PATIENT. THEY WERE REPORTED AS FINE POST THE PROCEDURE.
Patient problems: Discomfort
MAUDE report 18451268 ↗MalfunctionAug 10, 2023Material Separation; Material Separation
IT WAS REPORTED THAT: "AN INCIDENT OCCURED ON (B)(6) 2023 IN MEDICAL RESUSCITATION OF PNEUMOLOGY DEPARTMENT. THERE WAS A RUPTURE OF THE RIGHT WING OF THE JUNCTURE HUB DURING SUTURE FIXATION." THERE WAS NO CATHETER MIGRATION. IT WAS REPORTED THERE WAS NO PATIENT HARM OR CONSEQUENCE AS WHEN THE DEVICE BROKE, ANOTHER ONE WAS USED. THE WING OF THE SECOND DEVICE BROKE ALSO. THE CATHETER WAS NOT REMOVED AND THE USER "ATTACHED IT DIFFERENTLY TO SOLVE THE ISSUE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17504261 ↗MalfunctionAug 10, 2023Material Separation; Material Separation
IT WAS REPORTED THAT: "AN INCIDENT OCCCURED ON (B)(6) 2023 IN MEDICAL RESUSCITATION OF PNEUMOLOGY DEPARTMENT. THERE WAS A RUPTURE OF THE RIGHT WING OF THE JUNCTURE HUB DURING SUTURE FIXATION." THERE WAS NO CATHETER MIGRATION. IT WAS REPORTED THERE WAS NO PAITENT HARM OR CONSEQUENCE AS WHEN THE DEVICE BROKE, ANOTHER ONE WAS USED. THE WING OF THE SECOND DEVICE BROKE ALSO. THE CATHETER WAS NOT REMOVED AND THE USER "ATTACHED IT DIFFERENTLY TO SOLVE THE ISSUE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17504147 ↗MalfunctionJul 6, 2023Material Separation; Material Separation
IT WAS REPORTED THE CATHETER WAS INSERTED IN THE RIGHT INTERNAL JUGULAR ON (B)(6) 2023. ON (B)(6) 2023, THE DISTAL LINE WAS FOUND SEPARATED AT THE LEVEL OF THE FEMALE LUER HUB. THE DISTAL LINE WAS CLAMPED AND A NEW CATHETER WAS INSERTED IN THE LEFT INTERNAL JUGULAR ON (B)(6) 2023. IT WAS REPORTED THERE WAS NO CLINICAL CONSEQUENCE FOR THE PATIENT DUE TO THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTS "PATIENT DECEASED. DEATH IS NOT RELATED TO THE INCIDENT. DEATH IS DUE TO THE PATHOLOGY OF THE PATIENT." THE PATIENT DIED ON (B)(6) 2023. THE CAUSE OF DEATH IS REPORTED AS "COMA OF UNEXPLAINED ORIGIN IN A PATIENT WITH BLADDER CANCER, PROGRESSING TO NON-RESOLVING HYDROCEPHALUS DESPITE THE INSERTION OF AN EXTERNAL VENTRICULAR SHUNT, LEADING TO THE PATIENT'S DEATH".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17266987 ↗InjuryOct 6, 2021Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT: "THERE WAS A PROBLEM WITH A NON-FUNCTIONAL LINE: PHENOMENON OF NOREPINEPHRINE BOLUS WHILE USING THE MEDIUM LINE 1 AND 2 FOR OTHER DRUGS. THE NON-FUNCTIONAL LINE WAS PROPERLY CONNECTED TO THE PROXIMAL LINE." IT WAS REPORTED PRIOR TO USE "THE MIDDLE LINE WAS FLUSHED WITH SALINE BUT NOT THE PROXIMAL LINE BECAUSE NORADRENALINE WAS BEING INFUSED IN IT". IT WAS REPORTED THE PATIENT HAD NONSTABLE BLOOD PRESSURE THE DAYS BEFORE THE EVENT. THE PATIENT'S BLOOD PRESSURE WENT UP TO 250 SYSTOLIC AND THE CATHETER WAS CHANGED. PATIENT CONDITION REPORTED TO BE FINE.
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 12583086 ↗MalfunctionMar 23, 2021Crack; Crack
CUSTOMER REPORTED THE NEEDLE HUB WAS CRACKED. THE USER TRIED TO ASPIRATE BLOOD WITH THE INTRODUCER NEEDLE AND AIR CAME INTO THE SYRINGE. THERE WAS NO CONSEQUENCE FOR THE PATIENT. A NEW KIT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11556273 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K862056. One submission often covers many models, so check the product and lot details in each record.
- Z-2377-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
- Z-1118-2019 · Jan 10, 2019 · TerminatedArrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
- Z-1119-2019 · Jan 10, 2019 · TerminatedArrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
- Z-0723-2019 · Nov 14, 2018 · TerminatedArrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide sho
- Z-2819-2018 · Jul 10, 2018 · TerminatedHANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous cath
- Z-2818-2018 · Jul 10, 2018 · TerminatedHANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous cathe
- Z-2336-2018 · May 11, 2018 · TerminatedMulti-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single
- Z-1982-2018 · Apr 11, 2018 · TerminatedARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
- Z-1967-2018 · Apr 11, 2018 · TerminatedMaximal Barrier Drape; Product Code: ASK-04000-HMC
- Z-1978-2018 · Apr 11, 2018 · TerminatedTwo-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
- Z-1332-2018 · Dec 22, 2017 · Terminated(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12
- Z-0657-2018 · Oct 17, 2017 · TerminatedCentral Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
- Z-0648-2018 · Oct 17, 2017 · TerminatedMulti Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018
- Z-0652-2018 · Oct 17, 2017 · TerminatedMulti Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat
- Z-0650-2018 · Oct 17, 2017 · TerminatedMulti Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
…and 9 more.
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page