ARROW IPN033138Recalls & reported problems
Teleflex Incorporated · Central Venous Catheterization Set · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902100542), received between Aug 12, 2024 and Aug 12, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Missing Information” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Missing Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2024Missing Information; Missing Information
IT WAS REPORTED THAT: "ITEM WITHOUT CENTIMETER MARKINGS ON CATHETERS. CUSTOMER NOTICED THIS ON ALL CATHETERS FROM STOCK." ASSOCIATED COMPLAINTS: 9680794-2024-00759, 9680794-2024-00760, 9680794-2024-00761, 9680794-2024-00762, 9680794-2024-00763 AND 9680794-2024-00764.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958616 ↗MalfunctionAug 12, 2024Missing Information; Missing Information
IT WAS REPORTED THAT: "ITEM WITHOUT CENTIMETER MARKINGS ON CATHETERS. CUSTOMER NOTICED THIS ON ALL CATHETERS FROM STOCK." ASSOCIATED COMPLAINTS: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958584 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.