ARROW IPN030081Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801902102140), received between Jan 29, 2021 and Apr 15, 2026 — classified as 7 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Separation

  IT WAS REPORTED THAT "WHEN THE GUIDE WIRE WAS INSERTED, IT WOULDN'T GO THROUGH, AND WHEN THE GUIDE WIRE WAS REMOVED, IT BROKE AND OPENED UP, LEAVING PIECES OF THE WIRE IN THE CATHETER. IT WAS FIRST TRIED WITH THE CS-14402 AND THEN WITH THE CS-14403, HAVING THE SAME ISSUE WITH BOTH CVC". ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO THERAPY. THERE WAS NO PATIENT COMPLICATIONS OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL". ASSOCIATE MDR NUMBERS INCLUDE:3006425876-2026-00433.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887480 ↗
• InjuryMar 24, 2026Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT "ACCORDING TO THE REPORTED INFORMATION, THE PATIENT WAS IN THE OPERATING ROOM FOR A CVC INSERTION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE BECAME STUCK AND COULD NOT BE REMOVED FROM THE CATHETER. A LOSS OF INTEGRITY WAS OBSERVED, MAKING IT IMPOSSIBLE TO WITHDRAW THE SET (CATHETER AND GUIDEWIRE)". ADDITIONAL INFORMATION RECEIVED STATES "A PUNCTURE OF THE RIGHT SUBCLAVIAN VEIN IS PERFROMED WITH VENOUS RETURN ACHEIEVED ON THE SECOND ATTEMPT. USING THE SELDINGER TECHNIQUE THE GUIDWIRE IS ADVANCED RESULTING IN MULTIPLE KINKS THAT PREVENT FURTHER ADVANCEMENT. THE GUIDEWIRE IS WITHDRAWN. A PUNCTURE OF THE LEFT SUBCLAVIEIN VEIN IS PERFROMED, WITH VENOUS RETURNED ACHIEVED ON THE FIRST ATTEMPT. USING THE SELDINGER TECHNIQUE, THE GUIDEWIRE IS ADVANCED WITHOUT DIFFICULTY. A CENTRAL VENOUS CATHERTER IS INSERTED BUT CANNOT BE ADVANCED. AN ATTEMPT IS MADE TO REMOVE THE GUIDWIRE BUT IT CAN NOT BE EXTRACTED. LOSS OF CONSISTENCY AND STABILITY (FRAYING) OF THE GUIDEWIRE IS OBSERVED WITH A FRACTURE. A CHEST XRAY IS PERFROMED, SHOWING THE CATHETER GUIDEWIRE WITH LOOPS WITHIN THE VASCULAR TRACT." THE PATIENT WAS TRANSFERRED FOR EXTRACTION VIS PEDIATRIC CARDIAC CATHE

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 24673864 ↗
• MalfunctionMar 17, 2026Material Frayed; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING THE INSERTION OF THE CENTRAL VENOUS CATHETER, THE DEVICE MALFUNCTIONED, FRAYING THE GUIDE WIRE AND MAKING IT IMPOSSIBLE TO ADVANCE OR WITHDRAW THE GUIDE WIRE, AS IT BECAME STUCK INSIDE THE NEEDLE. IT WAS NECESSARY TO REMOVE THE ENTIRE PRODUCT (GUIDE NEEDLE) FROM INSIDE THE VESSEL". THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24616657 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "THE LUER-HUB (BROWN) LEAKAGE AT THE JUNCTION." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. 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 24344237 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "THE PATIENT DEVELOPED FEVER ASSOCIATED WITH BACTEREMIA DUE TO GRAM-NEGATIVE KLEBSIELLA PNEUMONIAE (MULTI-SENSITIVE), REQUIRING ADJUSTMENT OF ANTIBIOTIC THERAPY AND REMOVAL OF THE CENTRAL VENOUS ACCESS. DURING PLACEMENT OF A NEW CENTRAL VENOUS LINE, THE PATIENT DEVELOPED A LEFT HEMOTHORAX ASSOCIATED WITH HYPOVOLEMIC SHOCK DUE TO A "DEFECTIVE DEVICE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00832 AND 9680794-2025-00883.

  Patient problems: Bacterial Infection

  MAUDE report 23476722 ↗
• InjuryOct 15, 2025Material Disintegration; Physical Resistance/Sticking; Material Disintegration; Physical Resistance/Sticking

  IT WAS REPORTED "DURING PLACEMENT OF A NEW CENTRAL VENOUS LINE, THE PATIENT DEVELOPED A LEFT HEMOTHORAX ASSOCIATED WITH HYPOVOLEMIC SHOCK DUE TO A "DEFECTIVE DEVICE"." ADDITIONAL INFORMATION RECEIVED STATES "DURING THE PLACEMENT OF A NEW CENTRAL VENOUS ACCESS, AFTER ASEPSIS AND ANESTHESIA, THE AREA WHERE THE CATHETER WILL BE INSERTED (LEFT JUGULAR VEIN) IS VISUALIZED TOPICALLY, THE NEEDLE IS INSERTED, AND BLOOD RETURN IS CONFIRMED. AFTER THIS, A METAL GUIDE IS INSERTED, WHICH PASSES WITHOUT COMPLICATIONS IN A SINGLE ATTEMPT. AFTER THIS, IT IS DILATED WITH THE DILATOR THAT COMES WITH THE DEVICE, AND FINALLY, THE CATHETER IS INSERTED, WHICH HAD BEEN TESTED AND HAD RETURN IN THE NUMBERS. ONCE THE RETURN HAS BEEN VERIFIED, THE METAL GUIDE INSIDE THE CATHETER IS REMOVED, AND RESISTANCE IS EVIDENT AT THE MOMENT OF REMOVAL. WHEN THIS OCCURS, THE PROCEDURE GUIDELINES SUGGEST COMPLETELY REMOVING THE DEVICES TO AVOID ANY VASCULAR COMPROMISE. IT IS THEN EVIDENT THAT FROM THE TIP OF THE CATHETER INWARD, WHICH WOULD BE INTERNALLY IN THE YOUNGEST, IT WAS COMPLETELY DESTROYED AND DISINTEGRATED, SO THE DEVICE WAS REMOVED IN ITS ENTIRETY." FURTHER INFORMATION PROVIDED STATES "AFTER REMOVING THE DEV

  Patient problems: Hemothorax; Pain

  MAUDE report 23277662 ↗
• MalfunctionJul 16, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "AFTER TWO SUCCESSFUL PUNCTURE ATTEMPTS, IT WAS NOT POSSIBLE TO INSERT THE GUIDEWIRE INTO THE LEFT INTERNAL JUGULAR VEIN. THE LEFT FEMORAL VEIN WAS USED INSTEAD, OBTAINING VENOUS RETURN ON THE FIRST ATTEMPT. UNDER FLUOROSCOPIC GUIDANCE, A CENTRAL VENOUS CATHETER (4 FR, 13 CM) WAS PLACED AFTER DILATORS, VERIFYING ITS CORRECT POSITION AND VENOUS RETURN. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, WITH MINIMAL BLEEDING AND THE APPLICATION OF A STERILE PATCH". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22523346 ↗
• MalfunctionJul 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "OBSTRUCTION OF THE CENTRAL CATHETER LUMEN IS REPORTED, POSSIBLY DUE TO THE USE OF MEDICATIONS, ALTHOUGH NO PRECIPITATION IS OBSERVED IN THE EQUIPMENT. ATTEMPTS ARE MADE TO CLEAR THE OBSTRUCTION, BUT WITHOUT SUCCESS. THE CATHETER DOES NOT RETURN AND DOES NOT ALLOW THE MEDICATION TO PASS THROUGH. HEPARIN IS DILUTED TO A CONCENTRATION OF 1 ML/10 ML IN A 0.9% SALINE SOLUTION AND DOUBLE-DISTILLED WATER. THE AVAILABLE PERIPHERAL ROUTE IS USED AND THE DOCTORS ARE NOTIFIED OF THE SITUATION." THERE WAS 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 22506334 ↗
• MalfunctionJul 15, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "AN ATTEMPT WAS MADE TO PLACE THE CENTRAL VENOUS CATHETER (CVC) INITIALLY BY PUNCTURING THE RIGHT INTERNAL JUGULAR VEIN UNDER ULTRASOUND GUIDANCE. ALTHOUGH VENOUS RETURN WAS OBTAINED, THE GUIDEWIRE COULD NOT BE ADVANCED . TWO ADDITIONAL ATTEMPTS WERE MADE IN THE LEFT INTERNAL JUGULAR VEIN, WITHOUT SUCCESS. AFTER REPOSITIONING THE PATIENT (HIP ELEVATION, ABDUCTION, AND FLEXION OF THE EXTREMITIES), AND WITH ANTISEPSIS AND A STERILE FIELD, A PUNCTURE OF THE LEFT INGUINAL REGION WAS PERFORMED. SINCE THE GUIDEWIRE COULD NOT BE PASSED, IT WAS DECIDED TO MAKE AN INCISION MEDIAL TO THE FEMORAL PULSE. THE LEFT FEMORAL VEIN WAS IDENTIFIED, AND THE 13 CM, 4FR CATHETER WAS FINALLY INSERTED, WITH FLUOROSCOPIC CONFIRMATION OF ITS CORRECT POSITION." ECCHYMOSIS WAS OBSERVED THE PREVIOUS PUNCTURE SITES. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WERE NO PATIENT COMPLICATIONS BECAUSE OF THE ECCHYMOSIS.

  Patient problems: Easy Bruising

  MAUDE report 22506109 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED "CATHETER GUIDEWIRE BROKEN AT TIP." THIS WAS FOUND PRIOR TO USE. 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 22457475 ↗
• MalfunctionJul 7, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT "WHEN PASSING THE GUIDE WIRE, IT FRAYED, MAKING IT IMPOSSIBLE TO USE. IT WAS NECESSARY TO OPEN A NEW CATHETER FOR PASSAGE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414141 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PATIENT WITH DYSFUNCTIONAL RIGHT SUBCLAVIAN 4'13 CENTRAL VENOUS CATHETER, SO THE ON-DUTY INTENSIVIST PROCEEDS TO CHANGE THE CATHETER FOR A GUIDEWIRE. WHEN PURGING THE PROXIMAL ROUTE, A LEAK PROXIMAL TO THE BUTTERFLY IS OBSERVED." THE USER CHANGED TO A NEW SET. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941970 ↗
• MalfunctionApr 23, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED "FOUR ATTEMPTS ARE MADE TO PLACE A CENTRAL VENOUS CATHETER." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THE ATTEMPTS WERE THE "IT WAS INDICATED IN THE REFERRED AREA THAT THE METAL GUIDEWIRE WAS NOT ADVANCED, WHICH PREVENTED VENOUS RETURN FROM BEING OBTAINED AND CONSEQUENTLY THE CENTRAL VENOUS CATHETER WAS NOT INSTALLED." THE CUSTOMER ALSO STATES, THIS WAS THE "PROBABLE CAUSE OF THROMBOSIS IN PATIENT". THE CATHETER WAS REMOVED AND ENOXAPARIN WAS PRESCRIBED EVERY 12 HOURS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "PROGRESSING FAVORABLY". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2025-00318 AND 9680794-2025-00325.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21889595 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "AT THE END OF CENTRAL VENOUS CATHETER INSTALLATION BY GENERAL SURGERY SURGEONS, SIGNS OF THROMBOSIS ARE OBSERVED, REPORTED BY A NEUROSURGERY RESIDENT. DURING THE SAME PROCEDURE, CVC PLACEMENT WAS PERFORMED, INITIALLY IN THE FEMORAL ARTERY AND ATTEMPTED BILATERALLY WITHOUT OBTAINING RETURN OR GUIDE PASSAGE; AND FINALLY, IT WAS SUCCESSFUL IN THE LEFT SUBCLAVIAN ARTERY. ON ADMISSION TO THE FLOOR, THE PATIENT WAS DESCRIBED AS HAVING INCREASED VOLUME WITH ERYTHEMATOUS COLORATION OF THE RIGHT LOWER EXTREMITY, PULSES OF ADEQUATE INTENSITY, CAPILLARY REFILL OF 2 SECONDS, NEGATIVE GODETTE'S SIGN, NO PAIN ON THIGH OR LEG PRESSURE, NEGATIVE HOMANS' AND OLOW'S SIGNS, THE PATIENT WAS DIAGNOSED WITH FEMORAL DEEP VEIN THROMBOSIS, SO A DOPPLER ULTRASOUND (US) OF SAID EXTREMITY WAS REQUESTED, WHERE HE VERBALLY CONFIRMED THE DIAGNOSIS DUE TO THE RECENT DIAGNOSIS OF THROMBOSIS, AND WAS EVALUATED BY HEMATOLOGY, WHO REQUESTED BH LABORATORIES, IN ADDITION TO ADDING TREATMENT WITH ENOXAPARIN (1 MG/KG/DO) C/12H," THE PATIENT'S CURRENT CONDITION IS DESCRIBED AS "PROGRESSING FAVORABLY".

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21864171 ↗
• InjuryFeb 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "DURING INSERTION ON JUGULAR, THE SMALLER DILATATOR BROKE INSIDE THE PATIENT AND ONE PIECE OF IT REMAINED IN. A SMALL CUT ON THE VEIN HAD TO BE DONE TO BE ABLE TO REMOVE THE DILATOR'S PIECE LEFT INSIDE. THREE SUTURE POINTS WERE NEEDED TO CLOSE IT OFF. RISK THAT THE DILATOR'S PIECE WOULD HAVE MIGRATED INTO THE BLOODSTREAM. THE PIECE OF DILATOR WAS REMOVED FROM THE VEIN ENTIRELY. ONCE OUT THE VEIN, THE DILATOR BROKE OFF INTO EVEN SMALLER PIECES. AS THE SWG WAS ALREADY IN PLACE, THE SECOND DILATOR (LONGER ONE) WAS USED INSTEAD TO SUCCESSFULLY FINALIZE THE INSERTION OF THE CVC".

  Patient problems: Foreign Body In Patient

  MAUDE report 21313940 ↗
• InjuryFeb 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "DURING INSERTION ON JUGULAR, THE SMALLER DILATATOR BROKE INSIDE THE PATIENT AND ONE PIECE OF IT REMAINED IN. A SMALL CUT ON THE VEIN HAD TO BE DONE TO BE ABLE TO REMOVE THE DILATOR'S PIECE LEFT INSIDE. THREE SUTURE POINTS WERE NEEDED TO CLOSE IT OFF. RISK THAT THE DILATOR'S PIECE WOULD HAVE MIGRATED INTO THE BLOODSTREAM. THE PIECE OF DILATOR WAS REMOVED FROM THE VEIN ENTIRELY. ONCE OUT THE VEIN, THE DILATOR BROKE OFF INTO EVEN SMALLER PIECES. AS THE SWG WAS ALREADY IN PLACE, THE SECOND DILATOR (LONGER ONE) WAS USED INSTEAD TO SUCCESSFULLY FINALIZE THE INSERTION OF THE CVC".

  Patient problems: Foreign Body In Patient

  MAUDE report 21313857 ↗
• MalfunctionJan 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "CATHETER GUIDE WIRE BROKE AND REMAINED INSIDE THE CATHETER".

  Patient problems: Insufficient Information

  MAUDE report 21273691 ↗
• InjuryJan 2, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE INSERTION OF A CENTRAL CATHETER. THE SPRING-WIRE GUIDE (SWG) COULD NOT BE REMOVED. THE CATHETER WAS INSERTED PRIOR TO THE PLANNED SURGICAL PROCEDURE. DURING THE INSERTION, RESISTANCE WAS ENCOUNTERED AS THE CATHETER DESCENDED ALONG THE SGW. DUE TO THIS RESISTANCE, AN X-RAY WAS PERFORMED, WHICH REVEALED THAT THE SGW HAD LOOPED INSIDE THE PATIENT. MEDICAL INTERVENTION WAS NECESSARY TO ADDRESS THE ISSUE, AND THE SURGEON SUCCESSFULLY REMOVED THE GUIDEWIRE. IT WAS NOTED THAT NO SKIN INCISION WAS MADE BEFORE USING THE DILATOR, AND DURING THE DESCENT OF THE CATHETER ALONG THE GUIDEWIRE, THERE WAS A BLOCKAGE AFTER A FEW CENTIMETERS, PROMPTING THE X-RAY. ADDITIONALLY, THE CENTRAL LINE INSERTION PROCEDURE WAS NOT PERFORMED USING ULTRASOUND. A NEW CATHETER WAS INSERTED INTO LEFT JUGULAR VEIN. NO PATIENT HARM OR INJURY. THE CURRENT STATUS OF THE PATIENT IS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient

  MAUDE report 21057052 ↗
• MalfunctionDec 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "CATHETER KINKED (OBSTRUCTED), UNABLE TO PASS GUIDE WIRE".

  Patient problems: Insufficient Information

  MAUDE report 20986691 ↗
• MalfunctionDec 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG KINKED DURING USED ON THE PATIENT. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913745 ↗
• MalfunctionDec 4, 2024Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED "CATHETER DYSFUNCTION, BALLOON FORMATION WAS DETECTED IN THE CATHETER BODY." THE USER CHANGED TO A NEW SET. THERE IS 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 20842901 ↗
• MalfunctionDec 3, 2024Material Separation; Material Separation

  IT WAS REPORTED "FRACTURED METAL GUIDEWIRE UPON REMOVAL FROM THE CATHETER." THE DEVICE WAS REMOVED AND REPLACED. 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 20835806 ↗
• MalfunctionSep 10, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "AFTER PERFORMING THE PUNCTURE, WHEN PASSING THE GUIDE THREAD, IT STUCK INSIDE THE NEEDLE. THE GUIDE WIRE JUST ENTERED THE TIP AND MADE MEMORY. AT THE SAME MOMENT, ANOTHER CATHETER WAS OPENED AND THE PASSAGE WAS PERFORMED SUCCESSFULLY"." THE USER CHANGED TO A NEW SET. 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 20179314 ↗
• MalfunctionAug 26, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT " THEY CATHETERIZE AND WHEN THEY REMOVE THE GUIDEWIRE, THEY NOTICE PRESSURE (IT DOESN'T COME OUT SMOOTHLY). THEY TAKE OUT THE ENTIRE CATHETER AND IT COMES OUT FRAYED." ANATOMICAL INSERTION SITE OF THE DEVICE: NECK. DEVICE REMOVED AND USED ANOTHER CATHETER SUCCESSFULLY BUT THERAPY GOT DELAYED, NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062956 ↗
• MalfunctionJun 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT DURING THE INSERTION. THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE." 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 19444827 ↗

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, Classified
  Description/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-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• Z-1118-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
• Z-0723-2019 · Nov 14, 2018 · Terminated
  Arrow 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-2818-2018 · Jul 10, 2018 · Terminated
  HANDS-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-2819-2018 · Jul 10, 2018 · Terminated
  HANDS-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-2336-2018 · May 11, 2018 · Terminated
  Multi-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 · Terminated
  ARROWg+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 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• Z-1978-2018 · Apr 11, 2018 · Terminated
  Two-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-0652-2018 · Oct 17, 2017 · Terminated
  Multi 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-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
• Z-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
• Z-0648-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.