ARROW IPN030885Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10801902105339), received between Dec 19, 2022 and Mar 16, 2026 — classified as 7 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Difficult to Flush

  IT WAS REPORTED THAT "DURING INSERTION IT WAS IMPOSSIBLE TO FLUSH THE MEDIAL LINE. THE CATHETER WAS REPLACED BY A DIFFERENT ONE." 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 24607706 ↗
• MalfunctionFeb 11, 2026Unraveled Material

  IT WAS REPORTED THAT " THERE HAVE BEEN THREE INCIDENTS OF THE GUIDEWIRE'S CORE BREAKING AND STRETCHING DURING ATTEMPTED CVC INSERTION. THERE IS A RISK OF PARTS OF THE GUIDEWIRE BEING LEFT IN THE PATIENT. " ADDITIONAL INFORMATION RECEIVED STATES "ALL THREE INCIDENTS OCCURRED IN THE SAME PATIENT, WHOSE CONDITION IS CURRENTLY STABLE. IN EACH INSTANCE, THE GUIDEWIRE WAS COMPLETELY REMOVED FROM THE VESSEL AS A SINGLE, INTACT PIECE, AND NO FRAGMENTATION OCCURRED. THE ONLY MEDICAL INTERVENTION REQUIRED WAS A CHEST X-RAY." THE XRAY SHOWED NO PERMANENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 3006425876-2026-0015, 3006425876-2026-00186, AND 3006425876-2026-00185.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313525 ↗
• MalfunctionFeb 11, 2026Unraveled Material

  IT WAS REPORTED THAT " THERE HAVE BEEN THREE INCIDENTS OF THE GUIDEWIRE'S CORE BREAKING AND STRETCHING DURING ATTEMPTED CVC INSERTION. THERE IS A RISK OF PARTS OF THE GUIDEWIRE BEING LEFT IN THE PATIENT. " ADDITIONAL INFORMATION RECEIVED STATES "ALL THREE INCIDENTS OCCURRED IN THE SAME PATIENT, WHOSE CONDITION IS CURRENTLY STABLE. IN EACH INSTANCE, THE GUIDEWIRE WAS COMPLETELY REMOVED FROM THE VESSEL AS A SINGLE, INTACT PIECE, AND NO FRAGMENTATION OCCURRED. THE ONLY MEDICAL INTERVENTION REQUIRED WAS A CHEST X-RAY." THE XRAY SHOWED NO PERMANENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 3006425876-2026-0015, 3006425876-2026-00186.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313463 ↗
• MalfunctionFeb 11, 2026Unraveled Material

  IT WAS REPORTED THAT " THERE HAVE BEEN THREE INCIDENTS OF THE GUIDEWIRE'S CORE BREAKING AND STRETCHING DURING ATTEMPTED CVC INSERTION. THERE IS A RISK OF PARTS OF THE GUIDEWIRE BEING LEFT IN THE PATIENT. " ADDITIONAL INFORMATION RECEIVED STATES "ALL THREE INCIDENTS OCCURRED IN THE SAME PATIENT, WHOSE CONDITION IS CURRENTLY STABLE. IN EACH INSTANCE, THE GUIDEWIRE WAS COMPLETELY REMOVED FROM THE VESSEL AS A SINGLE, INTACT PIECE, AND NO FRAGMENTATION OCCURRED. THE ONLY MEDICAL INTERVENTION REQUIRED WAS A CHEST X-RAY." THE XRAY SHOWED NO PERMANENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATE MDR NUMBERS INCLUDE: 3006425876-2026-0015 AND 3006425876-2026-00185.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313439 ↗
• MalfunctionDec 22, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "AFTER GA, HYPOTENSION. CVC INSERTED TO START INOTROPE. WHEN INSERTED GUIDEWIRE, ARRYTHMIA NOTED AND GUIDEWIRE WITHDRAWN. HOWEVER, THE GUIDEWIRE GOT STUCK. AFTER 1 MINUTE, WIRE REMOVED SUCCESSFULLY AND SPRING ON GUIDEWIRE WAS EXPOSED." ADDITIONAL INFORMATION RECEIVED STATES "THE PATIENT DEVELOPED ARRHYTHMIA AS THE GUIDEWIRE ADVANCED INTO THE RIGHT ATRIUM. THE ARRHYTHMIA RESOLVED AFTER ATTEMPTING TO WITHDRAW THE GUIDEWIRE. HOWEVER, THE GUIDEWIRE WAS NOTED TO BE STUCK AT THAT TIME." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Arrhythmia

  MAUDE report 23864759 ↗
• MalfunctionDec 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR PERFORMS A PUNCTURE IN THE RIGHT SUBCLAVIAN VEIN, AND AS THE GUIDEWIRE IS PASSED, IT DEFORMS, CAUSING SEVERAL BENDS, SO IT IS REPLACED WITH ANOTHER CENTRAL VENOUS 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 23839404 ↗
• MalfunctionDec 3, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "RESUSCITATION PATIENT ON THE 2ND FLOOR, IN CRITICAL CONDITION, EMERGENCY PHYSICIAN PREPARES TO INSERT A CENTRAL VENOUS CATHETER INTO THE RIGHT SUBCLAVIAN VEIN. AFTER REMOVING THE DILATOR, UPON ATTEMPTING TO REMOVE THE GUIDEWIRE, THEY NOTICE THAT IT IS BENT AND CANNOT BE REMOVED, LEAVING IT INSIDE THE PATIENT'S RIGHT CLAVICULAR REGION." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER REPORTS THE GUIDEWIRE "DID NOT BEND; WHEN THE GUIDE WAS REMOVED, IT UNRAVELED." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DEATH DUE TO CAUSES ASSOCIATED WITH MORBIDITY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705165 ↗
• MalfunctionDec 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PLACEMENT OF THE CENTRAL VENOUS CATHETER IN THE RIGHT SUBCLAVIAN ACCESS, THE METALLIC GUIDEWIRE DID NOT SLIDE PROPERLY THROUGH THE NEEDLE, AND UPON REMOVAL OF THE METALLIC GUIDEWIRE, IT WAS OBSERVED THAT IT WAS BENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23692953 ↗
• MalfunctionDec 2, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "DIFFICULTY REMOVING THE METAL GUIDE. IT APPEARS TO OPEN IN TWO PARTS". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23692833 ↗
• MalfunctionDec 2, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING CVC PLACEMENT, THE NEEDLE, DILATED GUIDEWIRE, AND CATHETER WERE INSERTED WITHOUT DIFFICULTY. HOWEVER, REMOVING THE GUIDEWIRE PROVED DIFFICULT, REQUIRING THE GUIDEWIRE AND CATHETER TO BE REMOVED TOGETHER. UPON REMOVAL, THE GUIDEWIRE WAS FOUND TO BE BENT AND TWISTED. A DIFFERENT CATHETER FROM ANOTHER MANUFACTURER WAS USED." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23692779 ↗
• MalfunctionDec 2, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT "WHEN ATTEMPTING TO REMOVE THE CATHETER, IT BENT AT THE LEVEL OF THE SUBCUTANEOUS TISSUE, MAKING ITS REMOVAL DIFFICULT. THIS DELAYED THE START OF SURGERY AND CAUSED SKIN INJURY DUE TO THE BENDING OF THE CATHETER. A CATHETER FROM ANOTHER MANUFACTURER WAS USED WITHOUT ANY COMPLICATIONS". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23692718 ↗
• MalfunctionNov 18, 2025Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT "DURING THE CVC PLACEMENT PROCEDURE, THE ATTENDING PHYSICIAN, ATTEMPTING TO REMOVE THE GUIDEWIRE TO INTRODUCE THE CVC, EXPERIENCED DIFFICULTY REMOVING IT BECAUSE IT STRETCHED LIKE CHEWING GUM AND BECAME SOFT AND TORTUOUS. TWO MORE ATTEMPTS WERE MADE, BUT THE SAME FAILURE WAS DETECTED. A TOTAL OF THREE CVC DEVICES WERE FOUND TO HAVE FAILURES." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00950, AND 9680794-2025-00942.

  Patient problems: Insufficient Information

  MAUDE report 23585488 ↗
• MalfunctionNov 18, 2025Difficult to Remove; Material Too Soft/Flexible; Difficult to Remove; Material Too Soft/Flexible

  IT WAS REPORTED THAT "DURING THE CVC PLACEMENT PROCEDURE, THE ATTENDING PHYSICIAN, ATTEMPTING TO REMOVE THE GUIDEWIRE TO INTRODUCE THE CVC, EXPERIENCED DIFFICULTY REMOVING IT BECAUSE IT STRETCHED LIKE CHEWING GUM AND BECAME SOFT AND TORTUOUS. TWO MORE ATTEMPTS WERE MADE, BUT THE SAME FAILURE WAS DETECTED. A TOTAL OF THREE CVC DEVICES WERE FOUND TO HAVE FAILURES." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00951 AND 9680794-2025-00942.

  Patient problems: Insufficient Information

  MAUDE report 23585462 ↗
• MalfunctionNov 18, 2025Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT "DURING THE CVC PLACEMENT PROCEDURE, THE ATTENDING PHYSICIAN, ATTEMPTING TO REMOVE THE GUIDEWIRE TO INTRODUCE THE CVC, EXPERIENCED DIFFICULTY REMOVING IT BECAUSE IT STRETCHED LIKE CHEWING GUM AND BECAME SOFT AND TORTUOUS. TWO MORE ATTEMPTS WERE MADE, BUT THE SAME FAILURE WAS DETECTED. A TOTAL OF THREE CVC DEVICES WERE FOUND TO HAVE FAILURES." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00951, 9680794-2025-00950.

  Patient problems: Insufficient Information

  MAUDE report 23585425 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT " THE COMPLAINT RECEIVED AND DESCRIBED BY OUR CLIENT WAS THAT AFTER ADMITTING 2 PATIENTS TO THE OPERATION ROOM AND PUTTING THE CATHETER, THEY BOTH DEVELOPED SEPSIS. THE CLIENT HAS CARRIED BIOLOGICAL TEST THAT SHOWED THE PRESENCE OF SERRATIA MARCESCENS, THEY PERFORMED THE SAME TEST ON OTHER PATIENT AFTER REMOVING THE CATHETER WITH THE SAME BATCH NUMBER AND FOUND THE SAME RESULT." THE PATIENT UNDERTOOK ANTIBIOTIC THERAPY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00898 AND 3006425876-2025-00899.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 23199423 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT " THE COMPLAINT RECEIVED AND DESCRIBED BY OUR CLIENT WAS THAT AFTER ADMITTING 2 PATIENTS TO THE OPERATION ROOM AND PUTTING THE CATHETER, THEY BOTH DEVELOPED SEPSIS. THE CLIENT HAS CARRIED BIOLOGICAL TEST THAT SHOWED THE PRESENCE OF SERRATIA MARCESCENS, THEY PERFORMED THE SAME TEST ON OTHER PATIENT AFTER REMOVING THE CATHETER WITH THE SAME BATCH NUMBER AND FOUND THE SAME RESULT ." THE PATIENT UNDERTOOK ANTIBIOTIC THERAPY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00899.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 23199413 ↗
• MalfunctionJul 30, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "WHEN INSERTING THE CVC AFTER LOCATING AND PUNCTURING THE VEIN, THE DOCTOR INSERTED THE GUIDEWIRE WITHOUT DIFFICULTY. THEN HE SPREAD THE INSERTION POINT AND INSERTED THE CATHETER. WHEN THE GUIDEWIRE WAS REMOVED, IT HAD UNRAVELED AND WAS LESS RIGID. FINALLY, THE GUIDEWIRE WAS COMPLETELY REMOVED, AND THE CATHETER WAS ALSO REMOVED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22667703 ↗
• MalfunctionJul 8, 2025Difficult to Remove; Difficult to Advance; Material Twisted/Bent; Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED "WHEN THE ANESTHESIOLOGIST INSERTS A CENTRAL VENOUS CATHETER, THE GUIDE EASILY LOSES ITS SHAPE AND DOES NOT ALLOW ITS PROPER 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 22437935 ↗
• MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THERE WAS A LEAK IN THE DISTAL LINE: THE DRUG (PROPOFOL) WAS NOT INFUSED OR WAS INFUSED SUBCUTANEOUSLY. IT HAD SIGNIFICANT CONSEQUENCES SUCH AS A LONGER HOSPITAL STAY. PRODUCT WENT UNDER THE SKIN AND OUTSIDE THE SKIN. THE CATHETER WAS CHANGED AS SOON AS THE PROBLEM WAS NOTED." ADDITIONAL INFORMATION RECEIVED ON JUNE 03, 2025 INDICATED THAT "THE CLINICAL CONSEQUENCE WAS A LONGER HOSPITAL STAY AND THE PATIENT'S CLINICAL CONDITION IS NOW STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290153 ↗
• MalfunctionJun 4, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED "THE PATIENT ENTERS THE EMERGENCY SERVICE IN POOR GENERAL CONDITION. THEY ARE TRANSFERRED TO THE RESUSCITATION ROOM, WHERE THEY PRESENT INSTABILITY AND A CENTRAL VENOUS CATHETER IS PLACED. THE PROCEDURE IS PERFORMED WITH TWO INTENTIONS: THE FIRST IS TO GUIDE USING A DOUBLE GUIDE, AND THE SECOND IS THAT THE CATHETER CANNOT BE INSERTED IF A NEW KIT IS OPENED. THE PROCEDURE IS CARRIED OUT WITHOUT COMPLICATIONS." ADDITIONAL INFORMATION RECEIVED STATES " TWO ATTEMPTS ARE MADE TO PASS A TRILUMEN CENTRAL VENOUS CATHETER WITHOUT SUCCESS, AT THE FIRST ATTEMPT THE GUIDEWIRE BENDS AND THE CATHETER CANNOT BE USED. A NEW CVC KIT MUST BE UNCOVERED AND ON THIS OCCASION THE PROCEDURE IS PERFORMED WITHOUT COMPLICATIONS. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140578 ↗
• InjuryMay 6, 2025Material Separation; Material Separation

  IT WAS REPORTED, "THE PATIENT HAD BEEN DISINTUBATED THE DAY BEFORE. HE WAS MOBILIZED BY THE NURSE TO GET TO THE CHAIR. DURING MOBILIZATION, THE BLUE AND WHITE FIXATION HUBS PULLED OUT OF THE EXTENSION LINES. BOTH LINES WERE QUICKLY CLAMPED. THE PATIENT SOON PRESENTED RESPIRATORY DISTRESS (SUSPECTED GASEOUS PULMONARY EMBOLISM). HE WAS PLACED IN THE LEFT LATERAL DECUBITUS POSITION. THE PATIENT WENT INTO RESPIRATORY ARREST. THE PATIENT WAS RESUSCITATED. THE PATIENT IS NOW UNDER OBSERVATION IN INTENSIVE CARE AND HIS CONDITION IS STATIONARY. AT THE TIME OF THE INCIDENT, THE CENTRAL LINE WAS BEING USED TO ADMINISTER A 0.9 NACL SOLUTION. THE CENTRAL LINE HAS BEEN REPLACED. ADDITIONAL INFORMATION RECEIVED STATES "THE PATIENT IS STILL IN INTENSIVE CARE AND IS AT THE END OF HIS LIFE. THE DOCTORS ARE GOING TO SUGGEST TO THE FAMILY THAT CARE BE DISCONTINUED. THEY CONSIDER THAT THE EVENT THAT OCCURRED (SUSPECTED GAS EMBOLISM, RESPIRATORY ARREST AND RESUSCITATION) IS NOT RESPONSIBLE FOR HIS CRITICAL CONDITION, BUT THAT IT UNDOUBTEDLY ACCELERATED THINGS. THEY ARE AWARE THAT THE EVENT OCCURRED BECAUSE OF "MISS TREATING" OF THE PATIENT, AND THAT EXCESSIVE TENSION ON THE LINES (BLUE AND WHITE) IS RE

  Patient problems: Respiratory Arrest

  MAUDE report 21967895 ↗
• MalfunctionMay 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE GUIDE BENDS AND DOES NOT ALLOW TO BE PLACED." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21951534 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED " TWO PIECES - THE DILATOR BROKE DURING INSERTION OF THE CENTRAL CATHETER." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00468 AND 3006425876-2025-00467.

  Patient problems: Insufficient Information

  MAUDE report 21941337 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED " TWO PIECES - THE DILATOR BROKE DURING INSERTION OF THE CENTRAL CATHETER." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00468 AND 3006425876-2025-00467.

  Patient problems: Insufficient Information

  MAUDE report 21941334 ↗
• MalfunctionApr 15, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED "THE CLIENT REFERS THAT WHEN THE GUIDE WAS ADVANCED, IT CAME UNDONE, THEY WERE ABLE TO REMOVE IT COMPLETELY." ADDITIONAL INFORMATION RECEIVED REPORTS "THE GUIDE IS UNRAVELING WHEN INSERTED, IT IS COMPLETELY REMOVED." 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 21838888 ↗

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-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-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• 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-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-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
• 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-0654-2018 · Oct 17, 2017 · Terminated
  Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; 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

…and 9 more.