ARROW IPN924166Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10801902208702), received between Feb 14, 2023 and Sep 3, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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-2370-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " THE PEEL AWAY SHEATH/DILATOR INCIDENT HAPPENED AT TIP OF SHEATH. THE SHEATH MUSHROOMED AT TIP BUT ALSO BENT THE SHEATH. THE INSERTER HELD LOW ON THE SHEATH." THE PICC WAS PLACED WITH A NEW SHEATH. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00685, 9680794-2025-00686, 9680794-2025-00738, AND 9680794-2025-00723.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951640 ↗
• MalfunctionAug 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "DURING INSERTION SHEATH/DILATOR BUCKLED MICRO PUNCTURE KIT HAD TO BE USED". A SECOND ATTEMPT WAS COMPLETED SUCCESSFULLY WITH A NEW SHEATH. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00685, 9680794-2025-00686, 9680794-2025-00738, AND 9680794-2025-00723.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814235 ↗
• MalfunctionAug 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "DURING INSERTION SHEATH/DILATOR BUCKLED MICRO PUNCTURE KIT HAD TO BE USED". A SECOND ATTEMPT WAS COMPLETED SUCCESSFULLY WITH A NEW SHEATH. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00685, 9680794-2025-00686, 9680794-2025-00738, AND 9680794-2025-00723.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814175 ↗
• MalfunctionFeb 27, 2025Material Separation; Material Separation

  IT WAS REPORTED "TAB BROKE FROM SHEATH WHILE ATTEMPTING TO PEEL SHEATH. THE INSERTER WAS ABLE TO PEEL AWAY THE SHEATH WITH THE SINGLE TAB". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21477465 ↗
• MalfunctionFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED "TAB BROKE FROM SHEATH WHILE ATTEMPTING TO PEEL SHEATH. THE INSERTER WAS ABLE TO PRY THE SHEATH APART WITH A FINGERNAIL". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457219 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED "PEEL AWAY SHEATH THAT DID NOT BREAK APART, THE PLASTIC WING BROKE OFF". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356235 ↗
• MalfunctionJun 14, 2024Material Separation; Material Separation

  IT WAS REPORTED "HANDLE OF SHEATH BROKE OFF DURING INSERTION. THEY OPENED A STAND ALONE SHEATH." THERE WAS NO PATIENT HARM OR INJURY.NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536295 ↗
• MalfunctionJun 2, 2024Separation Problem; Separation Problem

  IT WAS REPORTED "WHEN THE TWO SIDES OF THE PEEL-AWAY SHEATH WERE SEPARATED, IT WAS NOTED THAT ONE OF THE SEAMS IN THE SHEATH HAD APPEARED TO HAVE SEPARATED IRREGULARLY AND HAD A A SERRATED EDGE. THE DEVICE FUNCTIONED NORMALLY BUT HAD AN ABNORMAL APPEARANCE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444861 ↗
• MalfunctionFeb 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "2 SEPARATE DILATORS PEELED BACK ON THEMSELVES DURING INSERTIONS." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER IS 9680794-2024-00213.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730680 ↗
• MalfunctionFeb 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "2 SEPARATE DILATORS PEELED BACK ON THEMSELVES DURING INSERTIONS." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBER IS 9680794-2024-00212.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730673 ↗
• MalfunctionFeb 14, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "DILATOR KINKED BACK ON ITSELF." THE DEVICE WAS REMOVED AND A NEW PEELAWAY SHEETH/DILATOR WAS USED. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707364 ↗
• MalfunctionJan 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: ONE SIDE OF THE PEEL-AWAY SHEATH BROKE OFF WHILE ATTEMPTING TO SEPARATE THE TWO HALVES. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594371 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: WHEN REMOVING PEEL AWAY SHEATH DURING PICC INSERTION, THE TAB BROKE OFF ONE SIDE OF THE SHEATH. THE SHEATH WAS REMOVED IN ITS ENTIRETY. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490945 ↗
• MalfunctionJan 3, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: GLIDE THRU SHEATH WRINKLED ON INSERTION. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "FINE". NO PATIENT INJURY/CONSEQUENCE OR MEDICAL INTERVENTION REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18433612 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT: THE SHEATH IN THE KIT WAS NOT SMOOTH. THERE WAS A RIPPLE LONG THE EDGE OF THE SHEATH (DESCRIBED AS A "SPUR"). THE PHYSICIAN DID NOT ADVANCE IT ALL THE WAY INTO THE PATIENT SO AS NOT TO CAUSE TRAUMA. THE CASE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595572 ↗
• MalfunctionAug 10, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED WHEN THE INSERTER WENT TO THREAD GUIDEWIRE, THE WIRE THREADED THROUGH THE NEEDLE AND VESSEL WITHOUT RESISTANCE. WHEN THE INSERTER PULLED BACK TO REMOVE WIRE, THE WIRE WAS STUCK AND WOULD NOT REMOVE EASILY. THE WIRE AND NEEDLE WERE REMOVED TOGETHER , AND ANOTHER KIT WAS USED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17506105 ↗
• MalfunctionMar 6, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: PICC ADVANCED AND TIP TRACKER APPEARS TO SHOW TWO CIRCLES IN THE AREA OF RIGHT SHOULDER REGION. PICC RETRACTED AND READVANCED WITH SAME CIRCLES AND PICC APPEARED DOWN. WHITE LUMEN WITH NO BLOOD RETURN. RN STATED THE PICC STYLET "DIDN'T FEEL RIGHT" AND REMOVED THE PICC AND STYLET. BOTH THE PICC AND STYLET HAD A BEND IN IT APPROXIMATELY 4-5 INCHES FROM THE DISTAL TIPS. THE STYLET WAS FULLY INTACT AND REINSERTED INTO THE PICC. A BUDDY WIRE WAS ADDED INTO THE SECOND LUMEN. BOTH LUMENS WERE FLUSHED WITH SALINE. PICC READVANCED AND TIP TRACKER DID NOT DISPLAY THE PICC ADVANCING. THE NAVICURE STYLET WAS REMOVED AND REPLACED WITH A TIP TRACKER STYLET AND THE T-PIECE STILL DID NOT SHOW THE ADVANCING OF THE PICC. IT WAS REPORTED THE PATIENT WAS STARTING TO LOSE A LOT OF BLOOD AND ALSO DROPPING OXYGEN SATURATION. THE PICC WAS REMOVED AND A CAPPED DILATOR PLACED. THE VASCULAR POSITIONING SYSTEM EQUIPMENT WAS CHANGED OUT AND PICC REINSERTED. TIP TRACKER SHOWED PICC ENTERING FROM THE RIGHT AND WENT DOWN. LACK OF BLOOD RETURN FROM WHITE LUMEN. PICC RETRACTED 2CM WITH BLOOD RETURN FROM BOTH LUMENS. THE PATIENT'S OXYGEN SATURATION REBOUNDED TO AN ACCEPTABLE LEVEL AND A

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Oxygen Saturation

  MAUDE report 16485998 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE PEELING THE SHEATH, THE INSERTER TORE OFF ONE OF THE WHITE WINGS. THE PATIENT WAS NOT HARMED , AND THE INSERTER WAS ABLE TO PULL THE REMAINING SHEATH OUT OF THE PATIENT'S SKIN AND PROCEED WITH INSERTION. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376521 ↗