ARROW IPN030749Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902104738), received between Jan 16, 2024 and Jun 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Migration; Migration

  IT WAS REPORTED BY CLINICAL STAFF AT THE HOSPITAL: "ULTRASOUND-GUIDED PLACEMENT OF A 2-LUMEN CVC IN THE RIGHT JUGULAR. ATRAUMATIC POSITIONING. DURING THE POSITIONING TESTS, A PERFECTLY FUNCTIONING PROXIMAL LUMEN WAS HIGHLIGHTED, AND THE DISTAL LUMEN FUNCTIONING WELL IN INFUSION, BUT NOT FUNCTIONING WELL IN SUCTION. AFTER WASHING, THE DISTAL LUMEN ALSO WORKED WELL IN SUCTION, ALLOWING BLOOD SAMPLES TO BE TAKEN FROM THIS LUMEN. AFTER POSITIONING A CT SCAN WAS PERFORMED FOR OTHER REASONS, HIGHLIGHTED THE PRESENCE OF A PNEUMOTHORAX AND MALPOSITION OF THE CVC, WHICH CAUSED THE DETACHMENT OF THE RIGHT PLEURA GOING DOWN BETWEEN THE MEDIASTINUM AND THE RIGHT PLEURA. THERE WAS NO CONSEQUENCE FOR THE PATIENT, WHO DIED IMMEDIATELY AFTERWARDS FOR STERCORACEOUS PERITONITIS FROM MASSIVE INTESTINAL PERFORATION." ADDITIONAL INFORMATION FROM THE CLINICAL STAFF AT THE HOSPITAL: "PATIENT ADMITTED TO THE EMERGENCY ROOM ON (B)(6), FOR RECURRENT FALLS AT HOME RESULTING IN LEFT TEMPORO-PARIETAL LACERATION AND TRAUMA TO THE RIGHT HIP: PATIENT FOUND ON THE GROUND BY HER SON. A DRAIN WAS PLACED AND REMOVED ON (B)(6). UPON ADMISSION: CACHECTIC, ENGAGED, SARCOPENIC PATIENT. HIS SON HAS REPORTED A PROGRESSIVE

  Patient problems: Pneumothorax

  MAUDE report 19536338 ↗
• MalfunctionApr 23, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, "ON (B)(6) 2024, SEVERAL TIMES DURING THE NIGHT AND THE PREVIOUS NIGHT THE ALARMS OF THE PUMP WENT OFF BECAUSE THE LINE OF THE CVC WAS CONSTANTLY KINKED AND HAD TAKEN A WRONG POSITION. SEVERAL TIMES THE DEVICE WAS REPOSITIONED. AT 0330, THE FEMALE PATIENT RANG THE NURSE AGAIN BECAUSE THE PUMP WAS ALARMING OCCLUSION. TUBING WAS CHECKED AGAIN AND ROLLED UP BEHIND HER NECK. THERE WERE SMALL TRACES OF BLOOD ON THE PILLOW. WITH THE SUDDEN APPEARANCE OF A BLOOD FLOW-RETURN IN THE TUBING. THE LINE WAS IMMEDIATELY CLAMPED. IT WAS OBSERVED THAT THE TUBING WAS CRACKED. HENCE THERE WAS A BLOOD FLOW-RETURN. THE CLEAR OCCLUSIVE DRESSING WAS APPLIED ON THE PARTIALLY RUPTURED LINE. THE CVC WAS REMOVED. PATIENT WAS POSITIONED IN DECUBITUS AND O2 HIGH CONCENTRATION INFUSED. A BRAIN SCAN WAS PERFORMED. PATIENT HAD NO UNUSUAL CLINICAL SIGNS SHE WAS CLOSELY MONITORED. THERE WAS NO REPORTED GAS EMBOLISM." THE PATIENT'S CURRENT CONDITION WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164781 ↗
• MalfunctionMar 29, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "WITH THE SUDDEN APPEARANCE OF A BLOOD FLOW-RETURN IN THE TUBING. THE LINE WAS IMMEDIATELY CLAMPED. IT WAS OBSERVED THAT THE TUBING WAS CRACKED.HENCE THERE WAS A BLOOD FLOW-RETURN. THE TEGADERM WAS APPLIED ON THE PARTIALLY RUPTURED LINE." THE CVC WAS REMOVED AND A BRAIN SCAN WAS PERFORMED. NO PATIENT HARM OR INJURY. IT WAS REPORTED "THE PATIENT HAD NO UNUSUAL CLINICAL SIGNS SHE WAS CLOSELY MONITORED. THERE WAS NO GAS EMBOLISM." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19008072 ↗
• MalfunctionJan 16, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "DURING INSERTION OF A PORTACATH, THE GUIDE DETERIORATED. THE GUIDE UNRAVELLED OVER 5 MILLIMETERS. THE ANAESTHETIST REALIZED THIS WHEN HE HAD DIFFICULTY REMOVING THE GUIDE." NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518753 ↗

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-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-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-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-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.