Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0625-2022 — Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (A

U.S. FDA — Device Enforcement · United States · 2022-01-11 · Class I

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0625-2022
Date of alert
2022-01-11
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
TELEFLEX MEDICAL INC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10801902121315
Reported risk: The firm received reports indicating PTD tip separation during use.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.