ARROW IPN036438Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10801902117189), received between Mar 23, 2021 and Jun 4, 2025 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

54 other recalls cover devices cleared under the same FDA submission (K071538); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED "CUSTOMER STATES THAT AFTER THE CATHETER WAS PLACED ~ 48 HOURS LATER ONE OF THE PIGTAILS CRACKED AND BEGAN LEAKING. THEY ARE NOT SURE WHICH PIGTAIL." THE CVC WAS REMOVED. 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 22144277 ↗
• MalfunctionNov 25, 2024Backflow; Gas/Air Leak; Backflow; Gas/Air Leak

  IT WAS REPORTED THAT "PATIENT'S POWER INJECTABLE CENTRAL LINE WAS USED FOR ADMINISTRATION OF CONTRAST FOR CT SCAN. BROWN, DISTAL PORT WAS USED. WHEN CONTRAST INJECTION LINE WAS REMOVED, DISTAL LINE WAS FILLED AIR. BLOOD WAS BACK FLOWING INTO LINE AND IT BECAME UNUSABLE." THE LINE WAS REPLACED AT THE BEDSIDE ON (B)(6) 2024. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "AWAKE, ALERT, AND CLINICALLY STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772731 ↗
• InjuryJan 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: 20CM OF OUTER SPRING WIRE SEPARATED AND WAS RETAINED IN THE PATIENT. THE FOREIGN OBJECT WAS IDENTIFIED BY XRAY APPROX. 5 DAYS AFTER CVC PLACEMENT. THE PATIENT WAS TRANSFERRED TO SURGERY FOR REMOVAL OF THE PIECE OF WIRE. NO HARM TO THE PATIENT IS KNOWN CURRENTLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18562475 ↗
• MalfunctionJan 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: THEY ARE HAVING ISSUES WITH THE CENTRAL LINE KITS. THE GUIDE WIRE IS SEPARATING DURING USE ON PATIENT. THERE WAS A DELAY OF CARE DUE TO HAVING TO REPEAT THE PROCEDURE BUT THERE WAS NO OTHER HARM REPORTED. THE PATIENT RECEIVED THE NECESSARY TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535622 ↗
• MalfunctionJan 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: THEY ARE HAVING ISSUES WITH THE CENTRAL LINE KITS. THE GUIDE WIRE IS SEPARATING DURING USE ON PATIENT. THERE WAS A DELAY OF CARE DUE TO HAVING TO REPEAT THE PROCEDURE BUT THERE WAS NO OTHER HARM REPORTED. THE PATIENT RECEIVED THE NECESSARY TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533364 ↗
• MalfunctionJan 18, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: THEY ARE HAVING ISSUES WITH THE CENTRAL LINE KITS. THE GUIDE WIRE IS UNCOILING. THERE WAS A DELAY OF CARE DUE TO HAVING TO REPEAT THE PROCEDURE BUT THERE WAS NO OTHER HARM REPORTED. THE PATIENT RECEIVED THE NECESSARY TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533356 ↗
• MalfunctionJan 18, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: THEY ARE HAVING ISSUES WITH THE CENTRAL LINE KITS. THE GUIDE WIRE IS UNCOILING. THERE WAS A DELAY OF CARE DUE TO HAVING TO REPEAT THE PROCEDURE BUT THERE WAS NO OTHER HARM REPORTED. THE PATIENT RECEIVED THE NECESSARY TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533340 ↗
• MalfunctionAug 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643700 ↗
• MalfunctionAug 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643401 ↗
• MalfunctionAug 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642969 ↗
• MalfunctionAug 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642877 ↗
• MalfunctionAug 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642815 ↗
• MalfunctionAug 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642758 ↗
• MalfunctionAug 29, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642720 ↗
• MalfunctionAug 25, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628646 ↗
• MalfunctionAug 25, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628258 ↗
• MalfunctionAug 25, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625479 ↗
• MalfunctionAug 25, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  CUSTOMER REPORTS THE NEEDLE BENDS AFTER INSERTION INTO THE PATIENT "WITH LITTLE FORCE/TORQUE AND ONLY WHILE IN SOFT ISSUE" AND WHEN THE NEEDLE HAS BEEN RETRACTED OUT OF THE PATIENT "ANY ATTEMPT TO CORRECT THE NEEDLE STRUCTURE RESULTS IN SNAPPING AT THE BASE NEAR THE SYRINGE PORT HUB". THERE WAS NO PATIENT HARM, "ONLY PROLONGED PROCEDURAL TIME AND MULTIPLE PROCEDURAL ATTEMPTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625342 ↗
• MalfunctionJun 25, 2021Unraveled Material; Unraveled Material

  THE COMPLAINT IS REPORTED AS: WHILE PLACING CENTRAL LINE, GUIDEWIRE BECAME DIFFICULT TO PULL OUT. WHILE PULLING OUT THE GUIDEWIRE, IT UNRAVELED IN MD'S HAND. WAS ABLE TO EXTRACT REMAINDER OF GUIDEWIRE. MD INSPECTED WIRE AND NOTED THAT ALL SECTIONS WERE INTACT. THERE WAS NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065303 ↗
• MalfunctionMay 10, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: WHEN THE DOCTOR WAS REMOVING THE WIRE, HE NOTICED THE WIRE HAD SEPARATED INSIDE THE PATIENT. XRAYS WERE TAKEN, AND REVEALED A SMALL CURVILINEAR METALLIC DENSITY OVERLYING THE RIGHT FEMORAL HEAD. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION AND THE PIECE OF WIRE WAS NOT REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS. NO DELAY IN TREATMENT. AT THE TIME OF THIS REPORT THE PATIENT HAD BEEN TRANSFERRED TO ANOTHER FACITLY FOR AN UNRELATED ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11803663 ↗
• MalfunctionMay 5, 2021Material Deformation; Material Deformation

  CUSTOMER REPORTED "THE J WIRE ON THE GUIDEWIRE LOOKS AS THOUGH IT IS ABOUT TO FALL OFF".THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776942 ↗
• MalfunctionApr 6, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE COMPLAINT IS REPORTED AS: DURING INSERTION, THE WIRE WAS UNABLE TO THREAD THROUGH THE CATHETER. THE USER TESTED IT INITIALLY AND IT WAS "A BIT STICKY" BUT THE USER TRIED TO DILATE THE CATHETER BY SLIDING THE WIRE THROUGH TWICE. THIS HELPED A LITTLE HOWEVER THE USER WAS UNABLE TO WITHDRAW THE WIRE THROUGH THE CATHETER ONCE IT WAS PLACED. THE CATHETER AND WIRE WERE REMOVED TOGETHER AND ANOTHER CATHETER WAS PLACED ON THE OPPOSITE SIDE. THE DEVICE DID NOT CAUSE INJURY OR DEATH, BUT IT WAS REPORTED THE PATIENT HAD A HEMATOMA. THE PATIENT'S CONDITION WAS REPORTED AS "GUARDED".

  Patient problems: Hematoma

  MAUDE report 11622311 ↗
• MalfunctionMar 23, 2021Material Integrity Problem; Material Integrity Problem

  THE COMPLAINT IS REPORTED AS: THE USER TRIED TO USE THE PRODUCT AND FOUND THAT THE ECHOGENIC NEEDLE WOULD NOT DRAW UP BLOOD. THE SYRINGE DID NOT HAVE ANY RESISTANCE WHEN PULLING IT BACK TO DRAW. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557745 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071538. One submission often covers many models, so check the product and lot details in each record.

• Z-2376-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
• Z-1914-2026 · Mar 11, 2026 · Open, Classified
  ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-4
• Z-2123-2026 · Jan 7, 2026 · Open, Classified
  Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
• Z-0002-2024 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
• Z-0003-2024 · Aug 10, 2023 · Open, Classified
  Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
• Z-0352-2023 · Oct 27, 2022 · Terminated
  Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-
• Z-0351-2023 · Oct 27, 2022 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
• Z-1604-2022 · May 25, 2022 · Open, Classified
  TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
• Z-1987-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
• Z-1994-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
• Z-1993-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1
• Z-1980-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
• Z-1996-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; P
• Z-1990-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
• Z-1979-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LD

…and 39 more.