Drug recall
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
FDA recall event 67893 · Class I · Micro Therapeutics Inc, Dba Ev3 Neurovascular
Key facts
| Event ID | 67893 |
|---|---|
| Recall numbers | Z-1453-2014, Z-1454-2014 |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Product type | Devices |
| Products | Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal., Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. |
| Initiation date | Apr 1, 2014 |
| Report date | Apr 23, 2014 |
| Termination date | Oct 31, 2014 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 1000220862 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: