ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vas...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3022-2018.
The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3022-2018.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3022-2018.
Micro Therapeutics Inc, Dba Ev3 Neurovascular
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Micro Therapeutics Inc, Dba Ev3 Neurovascular Recall FAQ
Micro Therapeutics Inc, Dba Ev3 Neurovascular is the subject of a surgical devices safety report: ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vas.... The notice was published on August 10, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 67 units are potentially affected.