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
Recalls naming this device
- 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
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- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.