ARROW IPN036451Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10801902117110), received between Sep 12, 2023 and Apr 25, 2025 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (10 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Material Separation; Material Separation

  IT WAS REPORTED "COIL END OF WIRE WAS BROKEN OFF INSIDE OF PATIENT." ADDITIONAL INFORMATION RECEIVED REPORTS " PATIENT HAD TO UNDERGO A SUBSEQUENT PROCEDURE IN ORDER TO REMOVE THE END OF THE WIRE THAT WAS RETAINED INSIDE OF THEM." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21908635 ↗
• MalfunctionJan 14, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE END OF THE DILATOR FRAYED AFTER USE ON PATIENT. THE CONDITION OF THE PATIENT IS REPORTED TO BE 'FINE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148474 ↗
• MalfunctionJan 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DILATOR "LOOKS FRAYED AT THE END" AFTER BEING REMOVED FROM THE PATIENT. THE DOCTOR REPORTED THAT THIS HAS HAPPENED AT LEAST FOUR TIMES IN THE LAST TWO WEEKS. THE PATIENT IS FINE AND HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00038, 9680794-2025-00037 AND 9680794-2025-00036.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112339 ↗
• MalfunctionJan 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DILATOR "LOOKS FRAYED AT THE END" AFTER BEING REMOVED FROM THE PATIENT. THE DOCTOR REPORTED THAT THIS HAS HAPPENED AT LEAST FOUR TIMES IN THE LAST TWO WEEKS. THE PATIENT IS FINE AND HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00039, 9680794-2025-00038, 9680794-2025-00037 AND 9680794-2025-00036.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112314 ↗
• MalfunctionJan 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DILATOR "LOOKS FRAYED AT THE END" AFTER BEING REMOVED FROM THE PATIENT. THE DOCTOR REPORTED THAT THIS HAS HAPPENED AT LEAST FOUR TIMES IN THE LAST TWO WEEKS. THE PATIENT IS FINE AND HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00039, 9680794-2025-00038, 9680794-2025-00037 AND 9680794-2025-00036.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112242 ↗
• MalfunctionJan 9, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE DILATOR "LOOKS FRAYED AT THE END" AFTER BEING REMOVED FROM THE PATIENT. THE DOCTOR REPORTED THAT THIS HAS HAPPENED AT LEAST FOUR TIMES IN THE LAST TWO WEEKS. THE PATIENT IS FINE AND HAD NO HARM OR INJURY. THE ASSOCIATED EMDR REPORT NUMBERS ARE 9680794-2025-00039, 9680794-2025-00038, 9680794-2025-00037 AND 9680794-2025-00036.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111978 ↗
• MalfunctionMar 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: WHEN THEY ARE DILATING A VESSEL THE TISSUE DILATOR TIP IS "SHREDDING" AND WARPS AT THE TIP. THERE IS NO SEPARATION OF THE DEVICE AND NO HARM TO THE PATIENT. ANOTHER KIT IS OPENED TO RESOLVE. ASSOCIATED COMPLAINTS: 9680794-2024-00266 AND 9680794-2024-00265.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958654 ↗
• MalfunctionMar 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: WHEN THEY ARE DILATING A VESSEL THE TISSUE DILATOR TIP IS "SHREDDING" AND WARPS AT THE TIP. THERE IS NO SEPARATION OF THE DEVICE AND NO HARM TO THE PATIENT. ANOTHER KIT IS OPENED TO RESOLVE. ASSOCIATED COMPLAINTS: 9680794-2024-00266, 9680794-2024-00267 AND 9680794-2024-00265.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958628 ↗
• MalfunctionMar 22, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: WHEN THEY ARE DILATING A VESSEL THE TISSUE DILATOR TIP IS "SHREDDING" AND WARPS AT THE TIP. THERE IS NO SEPARATION OF THE DEVICE AND NO HARM TO THE PATIENT. ANOTHER KIT IS OPENED TO RESOLVE. ASSOCIATED COMPLAINTS: 9680794-2024-00266, 9680794-2024-00267 AND 9680794-2024-00265.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957562 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728735 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728703 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728674 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728582 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728555 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728450 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728376 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728355 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728335 ↗
• MalfunctionSep 12, 2023Wrong Label; Wrong Label

  THE COMPLAINT IS REPORTED AS: PACKAGE LIDSTOCK AND SIDE CARD DO NOT MATCH REGARDING THE SKU AND PRODUCT DESCRIPTION. THE LIDSTOCK IS SHOWING CDC-45703-XP1A AND THE SIDE CARD IS SHOWING CDC-42808-XP1A. THE TRAY SHOULD BE A DOUBLE LUMEN TRAY FOR CDC-42802-XP1A. THEY DISCOVERED THE TRAYS WERE MISLABELED AS THEY WERE IN SURGERY BUT STILL NEEDED TO USE THEM DUE TO NOT HAVING OTHER TRAYS TO TRADE OUT WITH AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728307 ↗

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-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-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
• 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-2000-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
• 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-1988-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1

…and 39 more.