FDA Device recall Z-0211-2016
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy
- FDA Device
- Class I
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class I recall of RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy by Boston Scientific, citing boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Ro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0211-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-10-09 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, WI |
Product
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation designed for plaque modification and debulking in vascular interventions. This system is designed to travel over a specialized 0.009 guidewire to guide the path of burr travel to deliver therapy where intended. The guidewires are intended for use with the Rotablator Rotational Atherectomy System.
Reason
Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.
Identifiers
| code_info | Lots: 18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 18362094, 18378161, 18379210, 18384443 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0211-2016%22
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