ARROW IPN915621Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10801902162066), received between Apr 29, 2024 and Sep 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

   Z-2394-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831572 ↗
• MalfunctionFeb 23, 2026Crack; Gas/Air Leak

  IT WAS REPORTED THAT "WHILE INSERTING NEEDLE INTO PATIENT FOR A CENTRAL LINE IT IMMEDIATELY RETURNED AIR WHICH IS NOT COMMON DURING THIS STAGE OF THE PROCEDURE. I WAS CONCERNED I HAD CAUSED A PNEUMOTHORAX BUT THE NEEDLE WAS NOT DEEP ENOUGH INTO THE SKIN. I ATTEMPTED FROM A DIFFERENT ANGLE A SECOND TIME AND AGAIN GOT AIR IN THE SYRINGE AFTER PENETRATING THE SKIN MINIMALLY. I AGAIN WITHDREW THE NEEDLE AND MOVED TO A DIFFERENT LOCATION. WHEN ACCESSING THE FEMORAL VEIN WITH THE SAME NEEDLE, WHILE BLOOD WAS FILLING UP THE SYRINGE, I DISCOVERED BLOOD COMING FROM A CRACK IN THE PLASTIC PART OF THE NEEDLE WHERE IT CONNECTED TO THE SYRINGE. I WAS STILL ABLE TO FINISH THE PROCEDURE WITH NO HARM TO THE PATIENT. NO SIGNS/SYMPTOMS OF PNEUMOTHORAX WHEN I FINISHED BUT A CHEST X-RAY WAS PERFORMED TO VERIFY." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL". THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT WAS IN CRITICAL CONDITION PRIOR TO USING THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413744 ↗
• MalfunctionJan 23, 2026Device Damaged Prior to Use

  IT WAS REPORTED THAT "CLINICIAN ENCOUNTERED A DAMAGED SPRING WIRE GUIDE INSIDE CENTRAL LINE KIT PRIOR TO USE". THERE WAS NO PATIENT INVOLVEMENT. A NEW SET WAS USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162046 ↗
• MalfunctionJun 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED "I WAS MADE AWARE BY THE DOCTOR THAT SHE HAD A PROBLEM WITH THE ATTACHED CVL KIT WHEN SHE ATTEMPTED USE THIS AFTERNOON. SHE REPORTED THAT THE WIRE SHREDDED WHEN SHE TRIED TO PASS IT." A NEW KIT WAS USED. 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 22166123 ↗
• MalfunctionJul 17, 2024Stretched; Stretched

  THE REPORT STATES: "79 YO MALE HAD COMPUTED TOMOGRAPHY ANGIOGRAPHY CHEST (R/O PULMONARY EMBOLISM). UPON ADMINISTRATION OF FLUSH, BLUE LUMEN OF CENTRAL VENOUS CATHETER EXPANDED AND SPLIT 2/3 OF THE EXTERNAL LENGTH OF SAID LUMEN. THE LINE WAS THEN CLAMPED AND ANOTHER LUMEN USED FOR COMPLETION OF THE EXAM. THE PATIENT DID NOT C/O ANY ISSUES. NO EVIDENCE OF INFILTRATION AT SITE NOR EVIDENCE OF CATHETER DAMAGE DISTALLY ON IMAGING /NO EXTRAVASATION OF SITE EITHER. CENTRAL LINE WAS IDENTIFIED AS POWER INJECTABLE. PATENCY OF THE LINE WAS OBTAINED BY RAD TECH WITHOUT INCIDENCE. HAND SALINE FLUSH WAS COMPLETED WITHOUT INCIDENCE. POWER INJECTOR LINE WAS CONNECTED TO LUMEN WITH 5ML/SEC MARKED ON THE HUB." THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759839 ↗
• MalfunctionApr 29, 2024Stretched; Stretched

  IT WAS REPORTED "EXTENSION LINE BALLOONING. QUERY THAT IR WENT TO PRESSURE INJECT THROUGH LINE WITH CLAMP IN PLACE, BUT IR STATES THAT THE LINE WAS NOT CLAMPED AND EVERYTHING WAS WORKING FINE PRIOR AND DURING PRESSURE INJECTION". THE LINE WAS REPLACED. 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 19202020 ↗

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-1980-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC
• Z-1997-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH
• 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-1999-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-427
• 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-1992-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
• 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

…and 39 more.