CLASS I Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
RotaWire Elite and wireClip Torquer, Guidewire recalled
Boston Scientific is recalling RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy, distributed in 17 states. The recall was initiated on 9 Oct 2015 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0211-2016
- FDA event ID
- 72409
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Oct 2015
- FDA classified
- 12 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 9 Oct 2015 | Recall initiated by company | |
| 12 Nov 2015 | Classified by FDA | +34 days |
| 18 Nov 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa.
ArizonaCaliforniaDelawareFloridaGeorgiaIllinoisLouisianaMarylandMichiganMinnesotaNebraskaNew YorkPennsylvaniaSouth CarolinaTexasWashingtonWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lots: 18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 18362094, 18378161, 18379210, 18384443
Where was it sold?
Worldwide Distribution: US Distribution in the states of AZ, CA, DE, FL, GA, IL, LA, MD, MI, MN, NE, NY, PA, SC, TX, WA, and WI, and the countries of Belgium, Germany, Great Britain, Italy, Japan, and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 72409| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | RotaWire Elite and wireClip Torquer, Guidewire recalled | Boston Scientific | Packaging Defects | 17 states |
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |