ARROW IPN030757 (REF CS-12854-E)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902028980), received between May 18, 2021 and Jan 28, 2022 — classified as 3 malfunctions.

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

• MalfunctionJan 28, 2022Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED SOME LUMENS OF THE CVC WERE OBSTRUCTED AND COULDN'T BE USED. IT FIRST OCCURRED WITH THE BLUE LUMEN, WHERE SEDATION WITH DORMICUM AND SUFENTA AND RINGER'S WAS ADMINISTERED AT A FLOW OF AT LEAST 10 ML/HR UP TO 42 ML/HR. THE GREY MEDIAL LUMEN WAS ALSO OCCLUDED. THE OCCLUSION ALARM SOUNDED SEVERAL TIMES AND IT WAS POSSIBLE TO IRRIGATE AGAINST RESISTANCE, BUT SUDDENLY THIS WAS NO LONGER POSSIBLE. THERE WAS NO PATIENT INJURY. ANOTHER LUMEN WAS USED. IT WAS REPORTED THE CVC WAS CUT OPEN AND THERE WAS A LARGE BLOOD CLOT IN THE SYSTEM. IT WAS REPORTED THE PATIENT WAS ON VENTILATION WITH COVID AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388623 ↗
• MalfunctionJan 28, 2022Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTED SOME LUMENS OF THE CVC WERE OBSTRUCTED AND COULDN'T BE USED. IT FIRST OCCURRED WITH THE BLUE LUMEN, WHERE SEDATION WITH DORMICUM AND SUFENTA AND RINGER'S WAS ADMINISTERED AT A FLOW OF AT LEAST 10 ML/HR UP TO 42 ML/HR. THE GREY MEDIAL LUMEN WAS ALSO OCCLUDED. THE OCCLUSION ALARM SOUNDED SEVERAL TIMES AND IT WAS POSSIBLE TO IRRIGATE AGAINST RESISTANCE, BUT SUDDENLY THIS WAS NO LONGER POSSIBLE. THERE WAS NO PATIENT INJURY. ANOTHER LUMEN WAS USED. IT WAS REPORTED THE CVC WAS CUT OPEN AND THERE WAS A LARGE BLOOD CLOT IN THE SYSTEM. IT WAS REPORTED THE PATIENT WAS ON VENTILATION WITH COVID AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387757 ↗
• MalfunctionMay 18, 2021Unraveled Material; Unraveled Material

  IT WAS REPORTED THE GUIDEWIRE WAS UNRAVELED DURING REMOVAL. THERE WAS NO CONSEQUENCE FOR THE PATIENT, ONLY AN INCREASE OF THE TIME OF THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845087 ↗

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-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-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-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-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
• 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

…and 9 more.