RotaWire Elite and wireClip Torquer — Class I medical device recall Z-0212-2016
Terminated recall by Boston Scientific Corporation, reported 2015-11-18, distributed in AZ, CA, DE, FL, GA, IL, LA, MD…. Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire M
| Recall number | Z-0212-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2015-10-09 |
| Classified | 2015-11-12 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2017-10-13 |
| Distributed | AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, WI |
| Countries outside the US | BE, DE, GB, IT, JP, ZA |
| Reason classes | device malfunction |
| Lot numbers | 18141187, 18194620, 18220238, 18261834, 18285502, 18303265, 18390089 |
| Model numbers | H802233300, H802233301 |
Product
RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0212-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.