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ARROW IPN924172Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Two-Lumen PICC pre-loaded with Arrow(R) NaviCurve(TM) Stylet · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
13
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10801902208764), received between May 10, 2024 and Sep 3, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 9 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

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

Device problems

  • Material Separation11
  • Break3
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 3, 2025Material Separation; Material Separation

    IT WAS REPORTED "A PATIENT IN A CONFUSED MENTAL STATE GRASPED AND SEPARATED AN EXTENSION LINE HUB FROM THE EXTENSION." THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22951591 ↗
  • MalfunctionJun 20, 2025Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED "PICC INSERTED ON (B)(6) 2025. A CXR ON (B)(6) REVEALED A KINK INTERNALLY, 4.8 CM FROM THE INSERTION SITE, THAT ADVERSELY AFFECTED CATHETER PERFORMANCE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22298836 ↗
  • MalfunctionJun 11, 2024Material Separation; Material Separation

    IT WAS REPORTED "GLIDE-THRU SHEATH HANDLES BROKE OFF DURING INSETION OF PICC LINE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19509583 ↗
  • MalfunctionJun 11, 2024Material Separation; Material Separation

    IT WAS REPORTED "GLIDE-THRU SHEATH HANDLES BROKE OFF DURING INSERTION OF PICC LINE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19509409 ↗
  • MalfunctionJun 11, 2024Material Separation; Material Separation

    IT WAS REPORTED "GLIDE-THRU SHEATH HANDLES BROKE OFF DURING INSETION OF PICC LINE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS"UNKNOWN" AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19509300 ↗
  • MalfunctionJun 11, 2024Break; Break

    IT WAS REPORTED "WHITE TABS BROKE DURING INSERTION OF PICC LINE." 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 19508794 ↗
  • MalfunctionJun 10, 2024Material Separation; Material Separation

    IT WAS REPORTED THAT "GLIDE-THRU SHEATH HANDLES BROKE OFF DURING INSETION OF PICC LINE". THE SHEATH WAS REMOVED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTOIN REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19497920 ↗
  • MalfunctionJun 10, 2024Material Separation; Material Separation

    IT WAS REPORTED THAT "GLIDE-THRU SHEATH HANDLES BROKE OFF DURING INSETION OF PICC LINE". THE SHEATH WAS REMOVED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTOIN REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19497884 ↗
  • MalfunctionJun 10, 2024Material Separation; Material Separation

    IT WAS REPORTED THAT "GLIDE-THRU SHEATH HANDLES BROKE OFF DURING INSETION OF PICC LINE". THE SHEATH WAS REMOVED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTOIN REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19497860 ↗
  • MalfunctionJun 7, 2024Material Separation; Material Separation

    IT WAS REPORTED "WHITE TABS BROKE DURING INSERTION OF PICC LINE." 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 19482462 ↗
  • MalfunctionJun 2, 2024Material Separation; Material Separation

    IT WAS REPORTED "GLIDE-THRU SHEATH HANDLES BROKE OFF DURING INSETION OF PICC LINE". 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 19444866 ↗
  • MalfunctionMay 10, 2024Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT: "INSERTER HAD 2 MICROINTRODUCERS BREAK. THE BREAK OCCURED BETWEEN THE HANDLE OF THE MICROINTRODUCER AND THE SHEATH PORTION ON 2 SEPERATE KITS, AND 2 SEPERATE INSERTERS". THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19284011 ↗
  • MalfunctionMay 10, 2024Break; Material Separation; Break; Material Separation

    IT WAS REPORTED THAT: "INSERTER HAD 2 MICROINTRODUCERS BREAK. THE BREAK OCCURED BETWEEN THE HANDLE OF THE MICROINTRODUCER AND THE SHEATH PORTION ON 2 SEPERATE KITS, AND 2 SEPERATE INSERTERS". THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. ASSOCIATED COMPLAINTS: 9680794-2024-00443.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19283998 ↗

Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices

All Catheter, intravascular, therapeutic, long-term greater than 30 days devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.