ARROW IPN036236Recalls & reported problems
Teleflex Incorporated · Central Venous Catheterization Set · Class 2 · Implant
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902121148), received between Apr 16, 2025 and Apr 16, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
1 other recall cover devices cleared under the same FDA submission (K781978); 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking
IT WAS REPORTED "THE SWG WAS UNABLE TO PASS THROUGH THE DILATOR DURING THE PROCEDURE BECAUSE OF RESISTANCE. THEREFORE, THE KIT WAS REPLACED WITH A NEW KIT TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OCCURRED." ADDITIONAL INFORMATION RECEIVED STATES "THERE WAS A BURR LIKE DEFORMATION NEAR THE HUB ON THE DILATOR". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21847613 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K781978. One submission often covers many models, so check the product and lot details in each record.
- Z-2396-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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