ARROW IPN036482Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20801902117223), received between Aug 26, 2022 and Nov 19, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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. 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.

• MalfunctionNov 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "WE HAVE HAD A REPORTED LEAK WITH THE WHITE PORT ON MML HAVING A HOLE AND LEAKING WHEN FLUSHING." THE LINE WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". IT WAS REPORTED "IT IS NOT FELT THAT THE DEVICE HAD ANY FACTOR IN THE PATIENT'S DEATH."

  Patient problems: Insufficient Information

  MAUDE report 23596107 ↗
• InjuryOct 7, 2022Unraveled Material; Unraveled Material

  MEDWATCH RECEIVED REPORTS: "WHILE PLACING A RIGHT FEMORAL MML, DR. (B)(6) WAS REMOVING THE GUIDEWIRE, DR. (B)(6) STATED THAT SHE FELT THAT THE LINE BROKE. SHE REMOVED THE MML, AND GUIDEWIRE AND IT WAS DISCOVERED THAT THE GUIDEWIRE WAS FRAYED AND PARTIALLY CAME APART, POTENTIALLY BECOMING CATASTROPHIC TO THE PATIENT. DR. (B)(6) DECIDED TO DISCONTINUE THE LINE INSERTION. DR. (B)(6) HELD PRESSURE OVER THE INSERTION SITE TO STOP THE BLEEDING. DR. (B)(6) THEN DECIDED TO PLACE A DIFFERENT MML AT A DIFFERENT SITE. THE GUIDEWIRE AND PACKAGING FOR THE MML WAS SAVED FOR FURTHER INVESTIGATION."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15563196 ↗
• InjuryAug 26, 2022Material Frayed; Difficult to Remove; Material Separation

  WHILE PLACING A RIGHT FEMORAL MML, DR. (B)(6) WAS REMOVING THE GUIDEWIRE, DR. (B)(6) STATED THAT SHE FELT THAT THE LINE ¿BROKE¿. SHE REMOVED THE MML, AND GUIDEWIRE AND IT WAS DISCOVERED THAT THE GUIDEWIRE WAS FRAYED AND PARTIALLY CAME APART, POTENTIALLY BECOMING CATASTROPHIC TO THE PATIENT. DR. (B)(6) DECIDED TO DISCONTINUE THE LINE INSERTION. DR. (B)(6) HELD PRESSURE OVER THE INSERTION SITE TO STOP THE BLEEDING. DR. (B)(6) THEN DECIDED TO PLACE A DIFFERENT MML AT A DIFFERENT SITE. THE GUIDEWIRE AND PACKAGING FOR THE MML WAS SAVED FOR FURTHER INVESTIGATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15310902 ↗

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-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-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-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-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-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-2000-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
• Z-1989-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
• 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-1981-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
• 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-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-1980-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC

…and 39 more.