ARROW IPN918835Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902184419), received between May 14, 2026 and Jun 25, 2026 — classified as 3 malfunctions.

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

24 other recalls cover devices cleared under the same FDA submission (K862056); 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.

• MalfunctionJun 25, 2026Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING CENTRAL VENOUS CATHETER (CVC) PLACEMENT, THE SPRING WIRE GUIDE (SWG) WAS UNABLE TO ADVANCE THROUGH THE INTRODUCER NEEDLE INTO THE VEIN. WHEN THE USER ATTEMPTED TO WITHDRAW THE SWG, RESISTANCE WAS ENCOUNTERED, AND THE GUIDEWIRE BECAME STUCK WITHIN THE NEEDLE. DURING REMOVAL, THE SWG WAS OBSERVED TO STRETCH. AS A RESULT, BOTH THE INTRODUCER NEEDLE AND THE SWG WERE REMOVED FROM THE PATIENT SIMULTANEOUSLY. FOLLOWING REMOVAL FROM THE PATIENT, THE SWG WAS SUCCESSFULLY SEPARATED FROM THE NEEDLE WITHOUT FURTHER ISSUE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627550 ↗
• MalfunctionMay 29, 2026Entrapment of Device; Material Separation; Unraveled Material

  IT WAS REPORTED THAT DURING CENTRAL VENOUS CATHETER (CVC) INSERTION VIA THE INTERNAL JUGULAR VEIN; THE SPRING WIRE GUIDE (SWG) BECAME STUCK WITHIN THE PATIENT AND UNRAVELED UPON REMOVAL. ADDITIONAL INFORMATION INDICATED THAT COMPUTED TOMOGRAPHY (CT) PERFORMED IMMEDIATELY FOLLOWING THE EVENT CONFIRMED THAT A FRAGMENT OF THE SWG REMAINED IN THE SOFT TISSUES OUTSIDE OF THE VASCULAR SYSTEM. NO MEDICAL INTERVENTION WAS UNDERTAKEN TO REMOVE THE RETAINED FRAGMENT. THE PATIENT SUBSEQUENTLY DIED ON (B)(6) 2026 DUE TO UNDERLYING DISEASE. THE DEATH WAS NOT ATTRIBUTED TO THE REPORTED DEVICE ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25334772 ↗
• MalfunctionMay 14, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE ANESTHESIOLOGIST OBSERVED THE DISTAL EXTENSION LINE TO BE OBSTRUCTED AND NOT PATENT. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO DETERMINE WHETHER ANY MEDICAL INTERVENTION WAS REQUIRED. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25178565 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K862056. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• Z-1118-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
• Z-0723-2019 · Nov 14, 2018 · Terminated
  Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide sho
• Z-2819-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous cath
• Z-2818-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous cathe
• Z-2336-2018 · May 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single
• Z-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• Z-1982-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
• Z-1978-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
• Z-1332-2018 · Dec 22, 2017 · Terminated
  (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12
• Z-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
• Z-0652-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat
• Z-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
• Z-0648-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.