ARROW IPN030779Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10801902029017), received between May 27, 2021 and Mar 25, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Packaging Problem

  IT WAS REPORTED THAT "INCIDENT OCCURRED ON (B)(6) 2026, IN THE MEDICAL INTENSIVE CARE UNIT. AFTER THE INSERTION OF A CENTRAL VENOUS CATHETER IN THE LEFT JUGULAR VEIN, IT WAS OBSERVED THAT THE LENGTH OF THE CATHETER INSERTED (16 CM) DID NOT MATCH TO THE INDICATION ON THE SECONDARY PACKAGING (20 CM). THIS INCIDENT HAD NO CONSEQUENCES FOR THE PATIENT. A X-RAY WAS PERFORMED TO CONFIRM THE CORRECT PLACEMENT OF THE DEVICE. AFTER THIS INCIDENT, THE UNIT'S STOCK FROM THIS LOT# WAS CHECKED AND NO OTHER ISSUE WAS OBSERVED." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687972 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT " ON (B)(6) 2026 A FEMALE PATIENT WAS SENT TO THE PET CT SCAN DEPARTMENT. I RECEIVED A PHONE CALL FROM THE PET CT TEAM INFORMING ME THAT, DURING THE TRANSFER OF THE PATIENT, THE DISTAL LUMEN CAP CAME OFF. THE NURSE REPORTED THAT THE INCIDENT HAPPENED RIGHT IN FRONT OF HER; THE CLAMP WAS PROPERLY CLOSED AT THE TIME, AND SHE REACTED IMMEDIATELY BY APPLYING ANTISEPTIC COMPRESSES IN AN OCCLUSIVE MANNER TO THE END. WHEN THE PATIENT ARRIVED, I OBSERVED THAT THE DISTAL LUMEN OF THE TRIPLE LUMEN CENTRAL VENOUS CATHETER (INSERTED IN ICU ON (B)(6) 2026) WAS BROKEN BETWEEN THE CLAMP AND THE BROWN HUB. THE CLAMP WAS STILL SECURELY CLAMPED, AND THE COMPRESSES AND PROTECTIVE DRESSING WERE STILL IN PLACE. THE DOCTOR WAS INFORMED AND DECIDED TO REMOVE THE CENTRAL VENOUS CATHETER." THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558551 ↗
• InjuryOct 14, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "PATIENT UNDER NORADRENALINE ON THE PROXIMAL LINE, OVERPRESSURE OF THE ELECTRIC SYRINGE PUMP WHERE THE NORADRENALINE IS BEING PROVIDED THEREFORE TREATMENT IS INTERRUPTED. THERE WAS A SIGNIFICANT DECREASE OF ARTERIAL PRESSURE (SYSTOLE AT 5 MAP AT 40), DESATURATION DOWN AT 78% (PATIENT INTUBATED, SEDATED, VENTILATED AT 100% FIO2). THE NORADRENALINE WAS URGENTLY PROVIDED ON THE MEDIAL LINE." FURTHERMORE, IT WAS REPORTED "AFTER INFUSING THE NAD ON THE MEDIAN LINE, WE QUICKLY REGAINED A SATISFACTORY MEDIALE BLOOD PRESSURE." THE PATIENT WAS TRANSFERRED TO THE ICU DEPARTMENT. ADDITIONAL INFORMATION REPORTS "THE PATIENT SHOWED NO PARTICULAR SIGNS OR SYMPTOMS FOLLOWING THIS EVENT." THE PATIENT'S CURRENT STATUS IS REPORTED AS "STABLE".

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 20438703 ↗
• MalfunctionJan 8, 2024Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: INCIDENT OCCURRED ON (B)(6)2023. IN THE OPERATING THEATRE DURING A PUNCTURE IN THE LEFT JUGULAR VEIN UNDER ULTRASOUND, IT WAS FOUND THAT THE PUNCTURE NEEDLE COULD NOT BE INSERTED THROUGH THE GUIDE. THE GUIDE WAS STUCK IN THE NEEDLE, AND THE PROCEDURE WAS THEREFORE UNSUCCESSFUL. A COMPRESSION AND THE PRESENCE OF A VISIBLE HEMATOMA ON ULTRASOUND MADE IT IMPOSSIBLE TO PUNCTURE AGAIN ON THE LEFT WITH A 2ND KIT. SO A NEW PUNCTURE ON THE RIGHT WAS CARRIED OUT WITH A KIT FROM ANOTHER REFERENCE.

  Patient problems: Hematoma

  MAUDE report 18464100 ↗
• MalfunctionDec 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT "WE NOTICED THE DAMAGE WHEN TRYING TO INSERT THE CVC OVER THE SWG. THE CVC WAS THEN NOT USED AND REPLACED WITH ANOTHER ONE. THERE WAS NO DAMAGE TO THE PATIENT. AS NO USE OF FORCE WAS APPLIED BY THE ANESTHESIOLOGIST, WE ASSUME THAT THE CVC WAS REMOVED FROM THE PACKAGING IN EXACTLY THIS CONDITION". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373594 ↗
• MalfunctionDec 12, 2023Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: DURING THE INSERTION OF A CENTRAL CATHETER IN A PATIENT, THE DOCTOR ENCOUNTERED AN ISSUE. THE GUIDE WAS BLOCKED FROM INSERTION AND KINKED. ANOTHER DEVICE WAS USED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309153 ↗
• MalfunctionDec 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: DURING THE INSERTION OF A CENTRAL CATHETER IN A PATIENT, THE DOCTOR ENCOUNTERED AN ISSUE. WHEN THE GUIDE WAS INSERTED INTO THE DILATOR, THE GUIDE DEFORMED/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309121 ↗
• MalfunctionFeb 22, 2022Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED IT WAS DIFFICULT TO ADVANCE THE CATHETER ON THE GUIDE. THE CATHETER WAS BLOCKED AND THAT KINKED THE GUIDE. THE CATHETER WAS REMOVED AND THE SAME GUIDE WAS USED TO INSERT A NEW CATHETER AT THE SAME INSERTION SITE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581452 ↗
• MalfunctionMay 27, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT: "THE FLOW RATE OBSERVED ON THE MEDIUM LINE WAS UNEVEN (IRREGULAR)." IT WAS ALSO REPORTED "NORADRENALINE WAS INFUSED ON PROXIMAL LINE. SIGNIFICANT CHANGES IN BLOOD PRESSURE DURING BOLUSES ON THE MIDLINE. WE CHANGED THE DEVICE AND MADE THE SAME OBSERVATION." THE DEVICE WAS INSERTED 28 DAYS PRIOR. THE DEVICE WAS CHANGED AND REPLACED. IT WAS REPORTED THE PATIENT REMAINED IN THE HOSPITAL AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11895469 ↗
• MalfunctionMay 27, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED "THE FLOW RATE OBSERVED ON THE MEDIUM LINE WAS UNEVEN (IRREGULAR)." IT WAS ALSO REPORTED "THE NORADRENALINE WAS INFUSED ON THE PROXIMAL LINE. THE ADMINISTRATION OF BOLUS ON THE MEDIAN LINE LED TO A STRONG INCREASE IN BLOOD PRESSURE. THERE WAS STRONG SUSPICION OF BOLUSES OF NICOTINAMIDE ADENINE DINUCLEOTIDE. NO PRESSURE ALARM ON THE SYRINGE DRIVER." THE DEVICE HAD BEEN INSERTED 10 DAYS PRIOR. THE DEVICE WAS REPLACED. THE PATIENT REMAINED IN THE HOSPITAL AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11895093 ↗

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-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-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-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-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.