ARROW IPN035916Recalls & reported problems
Teleflex Incorporated · QuickFlash(R) Radial Artery Catheterization Set · Class 2
Quick summary
This Teleflex QuickFlash radial artery catheterization set is used to access a patient's radial artery for blood pressure monitoring and vascular access. The 73 reports mostly describe the guidewire or catheter coming apart, unraveling, or getting stuck, and blood leaking from connections that would not seal. Six reports describe injuries, and no deaths were reported. In one case a broken wire fragment remained in the patient's artery awaiting retrieval. No recalls name this device.
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
- 73
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00801902002761), received between Jan 29, 2021 and May 26, 2026 — classified as 6 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Material Separation” (20 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.
Reports received per month
Most reported problems
Device problems
- Material Separation20
- Unraveled Material16
- Physical Resistance/Sticking13
- Fluid/Blood Leak10
- Material Twisted/Bent6
- Material Deformation5
- Deformation Due to Compressive Stress4
- Incorrect, Inadequate or Imprecise Result or Readings4
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Insufficient Information7
- Foreign Body In Patient5
- Skin Inflammation/ Irritation3
- Administration Site Reaction1
- Easy Bruising1
- Localized Skin Lesion1
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Unraveled Material
IT WAS REPORTED THAT "THE GUIDEWIRE (LOOSE) UNRAVELED." 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 FOLLOWING REPLACEMENT WITH ANOTHER DEVICE. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278252 ↗MalfunctionMay 19, 2026Obstruction of Flow
IT WAS REPORTED THAT ON (B)(6) 2026, "WHEN MEDICAL STAFF PERFORMED PREOPERATIVE INVASIVE ARTERIAL PUNCTURE ON THE PATIENT, THE RADIAL ARTERY WAS SUCCESSFULLY ACCESSED, YET NO BLOOD RETURN WAS OBSERVED. AFTER REMOVING THE ARTERIAL PUNCTURE CATHETER KIT, BLOCKAGE OF THE ARTERIAL PUNCTURE FLEXIBLE TUBING WAS CONFIRMED. FLUSHING WITH A NORMAL SALINE SYRINGE WAS INEFFECTIVE. THE MEDICAL TEAM HAD TO REPLACE THE ENTIRE ARTERIAL PUNCTURE CATHETER KIT AND PERFORM A SECOND PUNCTURE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT, ASIDE FROM PATIENT DISCOMFORT RELATED TO A SECOND PUNCTURE. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH A NEW DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25221596 ↗MalfunctionApr 16, 2026Material Separation
IT WAS REPORTED THAT "ON (B)(6) 2026, IT WAS FOUND THAT THE NEEDLE SEPARATED FROM THE HUB. THE CATHETER WAS PROMPTLY REMOVED AND REPLACED WITH A NEW ONE". 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 24897318 ↗MalfunctionApr 3, 2026Fluid/Blood Leak; Loose or Intermittent Connection; Unable to Obtain Readings
IT WAS REPORTED THAT "ON (B)(6) 2026, DURING ARTERIAL CANNULATION ON A PATIENT, AFTER SUCCESSFUL PUNCTURE, WHEN CONNECTING THE CATHETER TO THE TRANSDUCER, IT WAS FOUND THAT THE CONNECTION COULD NOT BE FULLY TIGHTENED AND SEALED, RESULTING IN CONTINUOUS BLOOD LEAKAGE. THIS CAUSED THE INVASIVE BLOOD PRESSURE MONITORING TO FAIL. AFTER IMMEDIATELY REPLACING WITH A NEW ARTERIAL CATHETER KIT, THE CONNECTION WAS TIGHT AND BLOOD PRESSURE MONITORING RETURNED TO NORMAL". 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 24775615 ↗MalfunctionJan 29, 2026Disconnection; Unraveled Material
IT WAS REPORTED "QUICKFLASH WIRE UNRAVELLED AND DISCONNECTED DURING USE ON THE PATIENT. THEY PUT THE LINE IN ENGAGED THE WIRE, AS THEY PULLED IT OUT, IT WAS LIKE PULLING ROPE. THEY WERE ABLE TO REMOVE IT FROM THE PATIENT AS THE TIP WAS STILL CONNECTED". 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 24208731 ↗MalfunctionJan 29, 2026Leak/Splash; Material Separation
IT WAS REPORTED THAT"(B)(6) 2025, THE ANESTHESIOLOGIST PERFORMED RADIAL ARTERY PUNCTURE CATHETERIZATION FOR A PATIENT UNDERGOING GENERAL ANESTHESIA. BEFORE THE PROCEDURE, THE INTEGRITY OF THE CATHETER SET'S OUTER PACKAGING WAS CHECKED. AFTER SUCCESSFUL PUNCTURE, WHEN WITHDRAWING THE NEEDLE AND PREPARING TO ADVANCE THE CATHETER ACCORDING TO STANDARD OPERATING PROCEDURES, IT WAS DISCOVERED THAT THE CONNECTION BETWEEN THE NEEDLE AND THE CATHETER HAD SEPARATED, WITH THE BROKEN END REMAINING INSIDE THE CATHETER. AFTER REMOVING THE NEEDLE, THE REMAINING CATHETER WAS CONNECTED TO THE PRESSURE SENSOR, AND IT WAS IMMEDIATELY NOTICED THAT THERE WAS OOZING AT THE CONNECTION, MAKING IT IMPOSSIBLE TO FORM A CLOSED MONITORING CIRCUIT. THE FAULTY ARTERIAL CATHETER WAS IMMEDIATELY REMOVED, AND A NEW PUNCTURE WAS PERFORMED." 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 24208669 ↗MalfunctionJan 15, 2026Material Too Rigid or Stiff; Material Rupture
IT WAS REPORTED THAT "THE ARTERIAL CANNULA IS RIGID AND DOES NOT ADAPT TO THE RADIAL ARTERY, CAUSING IT TO RUPTURE." THERE WASN'T ANY PATIENT CONSEQUENCES OTHER THAN THE NEED TO OBTAIN A NEW ACCESS. ADDITIONAL INFORMATION RECEIVED STATES "THERE WAS AN ARTERIAL PERFORATION" SO COMPRESSION AND CONTINUOUS MONITORING WERE PERFORMED DURING THE DURATION OF THE SURGICAL PROCEDURE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Perforation of Vessels
MAUDE report 24090309 ↗InjuryJan 15, 2026Material Separation
IT WAS REPORTED THAT "DURING THE CANNULATION PROCEDURE OF THE RADIAL ARTERY, THE GUIDEWIRE BECOMES STUCK AND, WHILE ATTEMPTING TO REMOVE IT, IT BREAKS INSIDE THE ARTERY. IT IS CURRENTLY STILL IN THE PATIENT AWAITING RETRIEVAL." THE PATIENT CURRENT CONDITION IS REPORTED AS "FINE, BUT WITH THE PIECE INSIDE THE ARTERY."
Patient problems: Foreign Body In Patient
MAUDE report 24090266 ↗MalfunctionJan 15, 2026Difficult to Remove; Material Twisted/Bent
IT WAS REPORTED "ARROW CANNULA FAULTY - CENTRAL WIRE GETS STUCK WHEN PUSHED FORWARD- UNABLE TO RETRACK. THIS CANNULA WAS USED WHEN ATTEMPTING AN ARTLINE ON A PATIENT - COULD NOT RETRACK AND HAD TO PULL OUT OF PATIENT AS A WHOLE - CANNULA WAS RUCHED AND BUNCHED UP LIKE AN ACCORDION." THE PATIENT'S CURRENT CONDITION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24079473 ↗MalfunctionJan 15, 2026Difficult to Remove; Material Twisted/Bent
IT WAS REPORTED "ARROW CANNULA FAULTY - CENTRAL WIRE GETS STUCK WHEN PUSHED FORWARD- UNABLE TO RETRACK. THIS CANNULA WAS USED WHEN ATTEMPTING AN ARTLINE ON A PATIENT - COULD NOT RETRACK AND HAD TO PULL OUT OF PATIENT AS A WHOLE - CANNULA WAS RUCHED AND BUNCHED UP LIKE AN ACCORDION." THE PATIENT'S CURRENT CONDITION IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24079469 ↗MalfunctionDec 22, 2025Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking
IT WAS REPORTED "WHEN TRYING TO REMOVE THE GUIDEWIRE, IT BECAME STUCK AND DIDN'T COME OUT PROPERLY. CANNULATION NEEDED TO BE ABORTED DUE TO CONCERN OF FRAGMENTS LEFT BEHIND." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863510 ↗MalfunctionDec 11, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2025, THE ARTERIAL PUNCTURE CATHETER WAS INDWELLING IN THE RADIAL ARTERY AT THE WRIST. IF IT WAS FOUND THAT THE WAVEFORM PERCEPTION WAS NOT ACCURATE, THE CATHETER WAS REMOVED. IT WAS FOUND THAT THE CATHETER WAS KINKED, THE CATHETER WAS IMMEDIATELY REPLACED AND RE PUNCTURED." 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 23777290 ↗MalfunctionDec 11, 2025Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
IT WAS REPORTED THAT "(B)(6) 2025, 13:30, IN THE ARTERIAL PUNCTURE CATHETER GROUP, BLOOD EXUDATION WAS FOUND AT THE JUNCTION OF THE A RTERIAL NEEDLE DURING THE PROCESS OF ARTERIAL PUNCTURE AND CATHETERIZATION. IT WAS JUDGED THAT THE CAUSE OF BLOOD LEAKAGE WAS THE DEVICE CONNECTION FAILURE. AFTER TRYING TO ROTATE AND TIGHTEN THE CONNECTING PARTS AGAIN, THE PHENOMENON STILL DID NOT STOP. IMMEDIATELY TERMINATE THE OPERATION, REMOVE THE FAULTY ARTERIAL NEEDLE, REPLACE WITH A NEW ARTERIAL PUNCTURE INSTRUMENT, AND THEN RE OPERATE AND SUCCESSFULLY PLACE THE CATHETER." 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 23777217 ↗MalfunctionNov 24, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
IT WAS REPORTED THAT "PER PROVIDER: IT WAS A VERY SMOOTH PLACEMENT- ONE STICK (NOT THROUGH AND THROUGH) AND WHEN SHE TRIED TO REMOVE THE NEEDLE, IT WAS STUCK IN THE CATHETER. WE ENDED UP REMOVING THE ENTIRE CATHETER TO RE-STICK AND THE GUIDEWIRE WAS UNRAVELED AND COILED INSIDE OF THE A-LINE CATHETER (ALL OF IT WAS REMOVED IN ONE PIECE)". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Needle Stick/Puncture
MAUDE report 23631533 ↗MalfunctionNov 5, 2025Material Separation; Material Separation
IT WAS REPORTED THAT "THE GAP IN THE WHITE CONNECTOR, CAUSING POTENTIAL BLOOD LEAKAGE". THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476132 ↗MalfunctionOct 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "08 MAY 2025, THE DOCTOR FOUND SWG HANDLE/CHAMBER RESISTANCE WHEN DOING THE TESTING." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334657 ↗MalfunctionOct 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND SWG HANDLE/CHAMBER RESISTANCE WHEN DOING THE TESTING." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334648 ↗MalfunctionOct 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "ON (B)(6) 2025, THE DOCTOR FOUND SWG HANDLE/CHAMBER RESISTANCE WHEN DOING THE TESTING." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334623 ↗MalfunctionOct 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND SWG HANDLE/CHAMBER RESISTANCE WHEN DOING THE TESTING." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334611 ↗MalfunctionOct 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND SWG HANDLE/CHAMBER RESISTANCE WHEN DOING THE TESTING." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23255984 ↗MalfunctionSep 26, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "THE NEEDLE TIP DAMAGED." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23155522 ↗MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND THE LEAK WHEN THE CATHETER CONNECT WITH SENSORS DURING USE ON THE PATIENT." 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 "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22436129 ↗InjuryMay 19, 2025Material Separation; Material Separation
IT WAS REPORTED "WIRE UNRAVELLED". ADDITIONAL INFORMATION RECEIVED STATES "FAULTY WIRE IN PRODUCT, RESULTING IN FOREIGN BODY BEING LEFT INSIDE PATIENT'S RADIAL ARTERY. ADDITIONAL SURGERY, XRAYS, AN ANESTHESIA WERE DONE TO REMOVE THE FOREIGN PIECE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE" AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 22043526 ↗InjuryMay 6, 2025Material Separation; Material Separation
IT WAS REPORTED, "TIP BROKE OFF IN PATIENT ARTERY. PATIENT HAD ARTERIAL LINE INSERTED IN ED, FOLLOWING THE PATIENT PROCEDURES, PACU NURSE REMOVED ARTERIAL LINE FROM PATIENT, TIP OF THE ARTERIAL CANNULA WAS MISSING AND LEFT IN THE PATIENT'S RADIAL ARTERY. VASCULAR MEDICAL TEAM WAS CONSULTED AND REPORTED NO NEED TO RETRIEVE TIP OF ARTERIAL CANNULA FROM PATIENT RADIAL ARTERY. PACU NURSE INFORMED TREATING ANAESTHETIST, NEUROVASCULAR OBSERVATIONS AND ONGOING MONITORING OF THE PATIENT. ULTRASOUND WAS USED TO DETERMINE IF TIP PRESENT IN ARTERY (WAS CONFIRMED), ANAESTHETIST CONTACTED GEN SURGICAL AND VASCULAR TEAM FOR CONSULT. NO FURTHER INTERVENTION/EXPLORATION. PATIENT CONTINUED TO MONITOR NVO OVERNIGHT." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Foreign Body In Patient
MAUDE report 21967520 ↗MalfunctionMay 2, 2025Material Deformation; Material Deformation
IT WAS REPORTED "THE GUIDE WIRE IS DIFFICULT TO PUSH AND HAS BECOME DEFORMED." 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 "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951459 ↗
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, ClassifiedDescription/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, ClassifiedArrow 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, ClassifiedArrow 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-1968-2018 · Apr 11, 2018 · TerminatedRadial Arterial Access Kit; Product Code: ASK-04001-BID2
- Z-2019-2018 · Apr 11, 2018 · TerminatedArterial Catheterization Kit; Product Code:NA-04550-1A
- Z-1972-2018 · Apr 11, 2018 · TerminatedRadial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
- Z-1970-2018 · Apr 11, 2018 · TerminatedRadial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
- Z-1969-2018 · Apr 11, 2018 · TerminatedArterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
- Z-1971-2018 · Apr 11, 2018 · TerminatedArterial 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-1282-2018 · Oct 26, 2017 · TerminatedRadial Artery Catheterization Kit; Model: AK-04020
- Z-1283-2018 · Oct 26, 2017 · TerminatedRadial Artery Catheterization Kit; Model: AK-04020-C
- Z-1285-2018 · Oct 26, 2017 · TerminatedRadial Artery Catheterization Kit; Model: AK-04122
- Z-1286-2018 · Oct 26, 2017 · TerminatedRadial Artery Catheterization Kit; Model: AK-04220
- Z-1284-2018 · Oct 26, 2017 · TerminatedRadial Artery Catheterization Kit; Model: AK-04120
…and 17 more.
Other WIRE, GUIDE, CATHETER devices
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- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.