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ARROWRecalls & reported problems across all models

Teleflex Incorporated · 1,494 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

49 open recalls name at least one ARROW model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
9,043
Deaths reported
32
Injuries reported
533
Recalls
62

We found 1,494 models of ARROW by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 9,043 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2015 and Sep 30, 2026 — classified as 32 deaths, 533 injuries, 8,478 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (1,313 reports).

62 FDA recall records name at least one of these models by its device identifier, 49 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 169 reportsDec 2023: 166 reportsJan 2024: 197 reportsFeb 2024: 214 reportsMar 2024: 245 reportsApr 2024: 173 reportsMay 2024: 294 reportsJun 2024: 183 reportsJul 2024: 125 reportsAug 2024: 229 reportsSep 2024: 174 reportsOct 2024: 200 reportsNov 2024: 154 reportsDec 2024: 171 reportsJan 2025: 178 reportsFeb 2025: 141 reportsMar 2025: 122 reportsApr 2025: 155 reportsMay 2025: 158 reportsJun 2025: 150 reportsJul 2025: 161 reportsAug 2025: 125 reportsSep 2025: 97 reportsOct 2025: 138 reportsNov 2025: 178 reportsDec 2025: 129 reportsJan 2026: 167 reportsFeb 2026: 131 reportsMar 2026: 129 reportsApr 2026: 132 reportsMay 2026: 64 reportsJun 2026: 29 reportsJul 2026: 37 reportsAug 2026: 66 reportsSep 2026: 77 reportsOct 2026: 0 reports202420252026294
Last 36 months. The most recent month may be incomplete.

ARROW recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  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-2397-2026 · Root cause: Nonconforming Material/Component · names 26 of these models · Recall details · FDA record ↗

  2. 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-2396-2026 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

  3. 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-2394-2026 · Root cause: Nonconforming Material/Component · names 60 of these models · Recall details · FDA record ↗

  4. 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-2393-2026 · Root cause: Nonconforming Material/Component · names 14 of these models · Recall details · FDA record ↗

  5. 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-2391-2026 · Root cause: Nonconforming Material/Component · names 41 of these models · Recall details · FDA record ↗

  6. 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-2390-2026 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

  7. 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-2389-2026 · Root cause: Nonconforming Material/Component · names 7 of these models · Recall details · FDA record ↗

  8. 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-2388-2026 · Root cause: Nonconforming Material/Component · names 31 of these models · Recall details · FDA record ↗

  9. 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-2385-2026 · Root cause: Nonconforming Material/Component · names 44 of these models · Recall details · FDA record ↗

  10. 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-2384-2026 · Root cause: Nonconforming Material/Component · names 125 of these models · Recall details · FDA record ↗

  11. 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-2383-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  12. 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-2382-2026 · Root cause: Nonconforming Material/Component · names 11 of these models · Recall details · FDA record ↗

  13. 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-2381-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  14. 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-2380-2026 · Root cause: Nonconforming Material/Component · names 2 of these models · Recall details · FDA record ↗

  15. 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-2379-2026 · Root cause: Nonconforming Material/Component · names 3 of these models · Recall details · FDA record ↗

  16. 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-2378-2026 · Root cause: Nonconforming Material/Component · names 9 of these models · Recall details · FDA record ↗

  17. 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-2377-2026 · Root cause: Nonconforming Material/Component · names 18 of these models · Recall details · FDA record ↗

  18. 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-2376-2026 · Root cause: Nonconforming Material/Component · names 87 of these models · Recall details · FDA record ↗

  19. 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-2374-2026 · Root cause: Nonconforming Material/Component · names 6 of these models · Recall details · FDA record ↗

  20. 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-2373-2026 · Root cause: Nonconforming Material/Component · names 13 of these models · Recall details · FDA record ↗

  21. 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-2372-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  22. 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-2371-2026 · Root cause: Nonconforming Material/Component · names 48 of these models · Recall details · FDA record ↗

  23. 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 · names 16 of these models · Recall details · FDA record ↗

  24. 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-2369-2026 · Root cause: Nonconforming Material/Component · names 52 of these models · Recall details · FDA record ↗

  25. 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-2368-2026 · Root cause: Nonconforming Material/Component · names 56 of these models · Recall details · FDA record ↗

  26. 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-2367-2026 · Root cause: Nonconforming Material/Component · names 7 of these models · Recall details · FDA record ↗

  27. 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-2366-2026 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

  28. 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-2365-2026 · Root cause: Nonconforming Material/Component · names 5 of these models · Recall details · FDA record ↗

  29. 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-2364-2026 · Root cause: Nonconforming Material/Component · names 22 of these models · Recall details · FDA record ↗

  30. 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-2363-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

…and 32 older recalls, listed on each model's page.

Most reported ARROW problems

Device problems

  • Material Twisted/Bent1,313
  • Fluid/Blood Leak938
  • Material Separation618
  • Inflation Problem517
  • Physical Resistance/Sticking443
  • Leak/Splash395
  • Deformation Due to Compressive Stress382
  • Gas/Air Leak369

Patient problems

  • No Clinical Signs, Symptoms or Conditions6,585
  • Insufficient Information1,044
  • No Consequences Or Impact To Patient771
  • Foreign Body In Patient165
  • Needle Stick/Puncture83
  • Hemorrhage/Blood Loss/Bleeding70
  • Death42
  • Pain39

ARROW models

1,494 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

Recent ARROW adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Teleflex Incorporated products

All Teleflex Incorporated devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page