ARROW IPN915623Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902162080), received between Jul 3, 2023 and May 26, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Separation; Unraveled Material

  IT WAS REPORTED THAT THE SPRING WIRE GUIDE (SWG) WAS OBSERVED TO BE BROKEN/DAMAGED. THE TIMING AND CIRCUMSTANCES UNDER WHICH THE SWG DAMAGE OCCURRED WERE NOT SPECIFIED. FOLLOW-UP INQUIRIES WERE MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THE DEVICE FAILURE AND PATIENT OUTCOME; HOWEVER, NO RESPONSE OR FURTHER INFORMATION WAS RECEIVED AS OF THE DATE OF THE INITIAL MDR SUBMISSION.

  Patient problems: Insufficient Information

  MAUDE report 25283192 ↗
• MalfunctionMay 26, 2026Deformation Due to Compressive Stress; Insufficient Device Problem Information

  IT WAS REPORTED THAT IN THE EMERGENCY DEPARTMENT (ED), THE SPRING WIRE GUIDE (SWG) WAS OBSERVED TO BE BROKEN/DAMAGED BUT NOT SEPARATED. THE TIMING AND CIRCUMSTANCES UNDER WHICH THE SWG DAMAGE OCCURRED WERE NOT SPECIFIED. FOLLOW-UP INQUIRIES WERE MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THE DEVICE FAILURE AND PATIENT OUTCOME; HOWEVER, NO RESPONSE OR FURTHER INFORMATION WAS RECEIVED AS OF THE DATE OF THE INITIAL MDR SUBMISSION.

  Patient problems: Insufficient Information

  MAUDE report 25282879 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED "NO DEVIATION FROM HOSPITAL STANDPOINT. EQUIPMENT WAS BROKEN IN THE PACKAGING FROM MANUFACTURER." THIS WAS FOUND DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22123408 ↗
• MalfunctionOct 25, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "THE WIRE WAS ADVANCED INTO THE VEIN, AND ULTRASOUND CONFIRM VENOUS PLACEMENT OF THE WIRE. UNFORTUNATELY, ON REMOVAL ON THE NEEDLE, THE TIP OF THE WIRE BECAME FRAYED. AS SUCH IT WAS UNSAFE TO USE THIS WIRE, IT WAS PROMPTLY REMOVED, AND I OBTAINED A NEW STERILE WIRE. AFTER A NEW NEEDLESTICK, I THREADED A NEW WIRE INTO THE INTERNAL JUGULAR AND CONFIRM VENOUS PLACEMENT BY ULTRASOUND. SUBSEQUENTLY A SKIN NICK WAS PERFORMED, AND THE NEEDLE TRACT WAS DILATED. THE CATHETER WAS THEN THREADED SMOOTHLY OVER THE GUIDE WIRE AND THE GUIDE WIRE WAS REMOVED. APPROPRIATE BLOOD RETURN WAS OBTAINED EACH LUMEN OF THE CATHETER WAS EVACUATED OF AIR AND FLUSHED WITH STERILE SALINE. THE CATHETER WAS THEN SUTURED IN PLACE TO THE SKIN AND A STERILE DRESSING APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. BLOOD LOSS WAS MINIMAL." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENT ION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20532261 ↗
• MalfunctionJan 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "WHEN REMOVING THE GUIDE WIRE DURING CENTRAL LINE PLACEMENT, WIRE WAS SHEARED ON REMOVAL".

  Patient problems: Insufficient Information

  MAUDE report 18524028 ↗
• MalfunctionJul 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE CARDIO THORACIC SURGEON TRIMMED THE END OF THE CATHETER WHILE PERFORMING SURGERY ON THE HEART. THE CATHETER WAS CUT AFTER PLACEMENT, NOT PRIOR TO PLACEMENT. THERE WAS "AN UNUSUAL WHITE RUBBER PIECE NOTED IN ONE OF THE LUMENS, WHICH WAS ADHERENT WITHIN THE CATHETER". THE CUSTOMER REPORTED THE SURGEON TRIMS THE TIP OF THE CATHETER BECAUSE "THE END IS NEAR THE SITE OF SURGICAL REPAIR IN THE HEART AND THEY DON'T WANT HEALING IMPAIRED. WHEN THE CATHETER IS TOO LONG IT'S NEAR THE SURGICAL SITE AND IN THE FIELD OF SURGERY MAKING IT DIFFICULT TO WORK AROUND". THE PATIENT'S CURRENT CONDITION WAS UNKNOWN. IT WAS REPORTED "NO IMMEDIATE HARMS REPORTED".

  Patient problems: Insufficient Information

  MAUDE report 17321537 ↗
• MalfunctionJul 3, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  PHYSICIAN REPORTED PRIOR INCIDENT IN WHICH THE GUIDEWIRE UNRAVELED WHEN REMOVING THE DILATOR OFF OF THE WIRE. NO SPECIFIC EVENT DETAILS OR PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17249403 ↗
• MalfunctionJul 3, 2023Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THE PHYSICIAN WAS PERFORMING AN OVER THE WIRE CATHETER INSERTION AND WHEN THE PHYSICIAN PULLED OFF THE DILATOR OVER THE WIRE, THE TIP OF THE WIRE STARTED TO UNRAVEL. THE PHYSICIAN WAS ABLE TO PULL THE WIRE OUT, NO FOREIGN BODY WAS LEFT IN THE PATIENT. ANOTHER ARROW KIT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17249201 ↗

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-1992-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-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-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-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-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-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

…and 39 more.