ARROW IPN038527Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902142167), received between Apr 29, 2026 and May 26, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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-2384-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT "THE NURSE PRACTITIONER DURING INITIAL INSERTION OF THE CENTRAL VEIN CATHETER (CVC) OBSERVED THAT THE GUIDEWIRE BROKE (EXTERNAL TO THE PATIENT)." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE , " AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284408 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT THE PROVIDER ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO WITHDRAW THE GUIDEWIRE THROUGH THE CATHETER. DURING THIS PROCESS, THE GUIDEWIRE FRACTURED WHILE BOTH THE GUIDEWIRE AND CATHETER WERE STILL POSITIONED WITHIN THE PATIENT. AN X-RAY WAS PERFORMED, WHICH CONFIRMED THAT NO FRAGMENTS REMAINED WITHIN THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THE DIAGNOSTIC IMAGING PERFORMED TO CONFIRM THE ABSENCE OF RETAINED FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281079 ↗
• MalfunctionApr 29, 2026Physical Resistance/Sticking

  IT WAS REPORTED "THE CATH WOULD NOT THREAD OVER THE GUIDEWIRE." THIS WAS FOUND PRIOR TO USE. THE CUSTOMER REPORTED SIMILAR INCIDENTS HAS OCCURED HOWEVER FURTHER DETAILS WERE NOT PROVIDED FOR THOSE INCIDENTS. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2026-00380 AND .

  Patient problems: Insufficient Information

  MAUDE report 25033255 ↗
• MalfunctionApr 29, 2026Physical Resistance/Sticking

  IT WAS REPORTED "THE CATH WOULD NOT THREAD OVER THE GUIDEWIRE." THIS WAS FOUND PRIOR TO USE. THE CUSTOMER REPORTED SIMILAR INCIDENTS HAS OCCURED HOWEVER FUTHER DETAILS WERE NOT PROVIDED FOR THOSE INCIDENTS. ASSOCIATED MDR NUMBERS INCLUDE: (B)(4) AND (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032979 ↗

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-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-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-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-1995-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product
• 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
• 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-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.