ARROW IPN030102Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902102171), received between Dec 6, 2021 and Jan 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT "THE PATIENT PLANS TO UNDERGO RETROPERITONEAL TUMOR RESECTION SURGERY. AFTER ANESTHESIA INDUCTION INTUBATION, A FOUR LUMEN CENTRAL VENOUS CATHETER IS INSERTED THROUGH THE RIGHT SUBCLAVIAN CAVITY. THE THICK LUMEN CANNOT BE WITHDRAWN, WHILE THE OTHER THREE LUMENS CAN BE WITHDRAWN NORMALLY." 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 23986100 ↗
• MalfunctionAug 11, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT " WE WERE GOING TO ASPIRATE NORADRENALINE, TO CHANGE THE LINE WITH SEDATION WHERE PROPOFOL WAS ADMINISTERED. THE PATIENT HAD A 4-LUMEN CVC THAT WAS LOCATED ON THE LEFT SIDE OF THE NECK. DURING ASPIRATING NORADRENALINE, THE UNDERSIGNED DISCOVERS THAT PROPOFOL IS COMING OUT OF THE SYRINGE ALONG WITH BLOOD AND THAT IN THE LINE WHERE PROPOFOL IS ADMINISTERED, IT LOOKS LIKE AN AREA OF 4-5 CM CM WITH VACUUM OR AIR. THE PATIENT NO LONGER NEEDS NORADRENALINE AFTER ASPIRATION. THE ATTENDING PHYSICIAN INFORMS THE VISITING PHYSICIAN, WHO HAS NEVER SEEN THIS BEFORE. WHEN THE ATTENDING PHYSICIAN TRIES TO FLUSH THE LINE WITH NACL 0.9%, BLOOD COMES OUT IN THE LINE WHERE PROPOFOL IS ADMINISTERED. THE SAME IS TRIED WITH THE LINE WHERE PROPOFOL IS ADMINISTERED, WHERE BLOOD COMES OUT IN THE LINE WHERE NORADRENALINE HAS BEEN ADMINISTERED AND IT LOOKS LIKE VACUUM OR AIR AFTER THE BLOOD. IT IS DECIDED TO DISCON TINUE THE CVC AND INSERT 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 22770464 ↗
• MalfunctionApr 29, 2025Material Rupture; Material Rupture

  IT WAS REPORTED "INVOLVED 76-YEAR-OLD PATIENT ADMITTED TO INTENSIVE CARE FOR ENCEPHALOPATHY IN THE CONTEXT OF ACUTE RENAL FAILURE. THE BROWN HUB OF THE DISTAL LINE RUPTURED DURING CARE. THE RIGHT FEMORAL CENTRAL VENOUS LINE WAS INSERTED ON (B)(6) 2025. NO DIRECT CONSEQUENCES, AS THE LINE WAS CLAMPED IMMEDIATELY." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927839 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT " (B)(6) HOSPITAL, (B)(6), REPORTS A PRODUCT DEVIATION ON ARROW CVC. THE CVC SNAPPED OFF CLOSE TO THE LUER CONNECTION WHERE THE 3-WAY STOP COCK IS MOUNTED. FORTUNATELY, CLAMPS ON THE EXTENSION LINE WERE CLAMPED OFF SINCE THE LUMEN WAS NOT IN USE. THE CATHETER HAD BEEN IN THE PATIENT FOR 28 DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866111 ↗
• MalfunctionDec 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "WHEN THE USER ATTEMPTED TO FLUSH THE CATHETER AFTER PLACEMENT, LEAK WAS CONFIRMED NEAR THE JUNCTION HUB. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW KIT (LOT#: UNKNOWN). NO INJURY TO THE PATIENT OCCURRED". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401644 ↗
• MalfunctionDec 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: THE CVC WAS INSERTED IN JUGULAR ON 18 OCT 2021 IN THE CARDIAC CATHETERIZATION ROOM. THE CVC WAS FOUND ON 21 OCT 2021 AT 8.30 AM LEAK ING (HOLE) AT THE LEVEL OF THE DISTAL LINE. AIR WENT THROUGH THE TUBING OF THE LINE. THE PATIENT WAS SCHEDULED TO TAKE A PETSCAN AT 9.15 A.M. PARAMEDICS ARRIVED ON THE WARD BUT THE CATHETER HAD TO BE CHANGED. THIS DELAYED THE EXAM AND REQUIRED A REORGANIZATION OF THE SCHEDULE OF THE AMBULANCES. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12943668 ↗

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-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-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• 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-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-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-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-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
• 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

…and 9 more.