ARROW IPN030853Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902105216), received between Dec 20, 2024 and Apr 30, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Difficult to Advance

  IT WAS REPORTED THAT " DURING PLACEMENT OF THE CVC IN THE RIGHT INTERNAL JUGULAR VEIN, DIFFICULTY WAS ENCOUNTERED IN ADVANCING THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE, MAKING IT IMPOSSIBLE TO PROCEED AND REQUIRING REMOVAL OF BOTH NEEDLE AND GUIDEWIRE. THE PLACEMENT WAS THEN COMPLETED WITH A NEW CVC ON THE OPPOSITE SIDE OF THE PATIENT." 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 25043878 ↗
• MalfunctionMar 31, 2026Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT "CVC PLACEMENT GUIDED BY ULTRASOUND. VASCULAR PUNCTURE WITHOUT ANY COMPLAINTS, GUIDEWIRE IS PASSED THROUGH THE NEEDLE AND GETS STUCK A BIT INSIDE THE NEEDLE. THEN IT CANNOT BE REVERSED BUT STARTS TO WIND UP AT THE END THAT STICKS OUT OF THE NEEDLE. NEEDLE, WITH GUIDEWIRE STILL IN THE NEEDLE, IS REMOVED FROM THE PATIENT AND A NEW CVC SET IS USED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNAFFECTED BY THE INCIDENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741679 ↗
• MalfunctionJan 2, 2026Difficult to Remove

  IT WAS REPORTED THAT "AN INCIDENT OCCURRED ON (B)(6) 2025 IN THE OPERATING THEATRE. THE GUIDE WIRE FOR THE CENTRAL LINE REMAINED STUCK IN THE FEMALE PATIENT. IT WAS VERY DIFFICULT TO REMOVE IT AFTER THE CENTRAL LINE HAD BEEN INSERTED. NO CLINICAL CONSEQUENCES FOR THE PATIENT". ADDITIONAL INFORMATION RECEIVED STATES THE DEVICE "WAS KINKED EVEN THOUGH IT DID NOT ENCOUNTER ANY OBSTACLES". 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 23943026 ↗
• MalfunctionJun 17, 2025Obstruction of Flow; Difficult to Advance; Material Twisted/Bent; Obstruction of Flow; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT "AN INCIDENT OCCURRED ON (B)(6) 2025 IN SURGERY ROOM. THE GUIDE WAS BLOCKED IN THE CATHETER." FURTHER INFORMATION CLARIFIES "AFTER 7-8 CM, IT WAS IMPOSSIBLE TO ADVANCE ANY FURTHER AND IMPOSSIBLE TO REMOVE THE GUIDE FROM THE NEEDLE. WE HAD TO REMOVE THE ENTIRE NEEDLE. THE GUIDE CAME OUT ENTIRELY BUT COMPLETELY BENT AT THE EXIT POINT OF THE NEEDLE, AS IF IT HAD BEEN 'DAMAGED' OR 'TWISTED' BY THE TIP OF THE NEEDLE." ADDITIONAL INFORMATION RECEIVED STATES "THERE WERE THREE INCIDENTS EXACTLY THE SAME CONFIGURATION, IT WAS THE JUGULAR IN EACH CASE, BUT A DIFFERENT OPERATOR WAS INVOLVED IN EACH ACCIDENT." THE GUIDE WIRE WAS REMOVED AND ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER INCLUDE: 3006425876-2025-00597, 3006425876-2025-00599, AND 3006425876-2025-00600.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235968 ↗
• MalfunctionApr 16, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED " UPON INSERTION, THE GUIDEWIRE (AT SOME POINT) HAS COILED UP AND THE STEEL AROUND THE GUIDEWIRE HAD LOOSENED." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES "THE GUIDEWIRE BECAME STUCK IN THE NEEDLE (INTRODUCER) AND HAD TO BE PULLED OUT IN ITS ENTIRETY." A NEW SWG WAS INSERTED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21846807 ↗
• MalfunctionDec 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "WHILE IN USE, THE GUIDEWIRE DEFORMED". THE CONDITION OF THE PATIENT IS UNKNOWN. SEVERAL ATTEMPTS WERE MADE TO GET ADDITIONAL INFORMATION; HOWEVER, NOTHING WAS RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20988047 ↗
• MalfunctionDec 20, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "WHILE IN USE, THE GUIDEWIRE DEFORMED". THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20986882 ↗

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-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-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 · 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-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-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.