CLASS I Device recall · Reported 27 Nov 2013 · FDA Enforcement Report

Thunder¿ Steerable Guidewire recalled by Medtronic Vascular

Medtronic Vascular is recalling Thunder¿ Steerable Guidewire, distributed nationwide in the US. The recall was initiated on 21 Oct 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesG13A00116 G13A00936 GV260 GV846

Quantity recalled1205

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-0267-2014
FDA event ID: 66567
Recalling firm: Medtronic Vascular, Danvers, MA
Classification: Class I
Status: Terminated
Recall initiated: 21 Oct 2013
FDA classified: 15 Nov 2013
Reported: 27 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Oct 2013	Recall initiated by company
15 Nov 2013	Classified by FDA	+25 days
27 Nov 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Product as listed by the FDA

THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Where it was distributed

Worldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guyana, Honduras, Hong Kong,Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Montenegro, Nepal, Netherlands, New Zealand, Nepal, Nicaragua, Norway, Oman, Poland, Portugal Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, United Kingdom, Uruguay, and Yemen.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Stores named: Target

Questions about this recall

Is Thunder¿ Steerable Guidewire recalled?

Yes. Medtronic Vascular recalled Thunder¿ Steerable Guidewire on 21 Oct 2013. The recall is Class I and its status is Terminated. Recall number Z-0267-2014.

Why was it recalled?

Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

Which lots are affected?

G13A00116 G13A00936 GV260 GV846

Where was it sold?

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Vascular

All 227

Reported	Class	Recall	Company	Reason	Where
18 May 2022Device	CLASS II	Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon recalled	Medtronic Vascular	Sterility	Nationwide
18 May 2022Device	CLASS II	Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter recalled	Medtronic Vascular	Sterility	Nationwide
1 Dec 2021Device	CLASS II	Endurant IIs Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide
1 Dec 2021Device	CLASS II	Endurant II Stent Graft System recalled by Medtronic Vascular	Medtronic Vascular	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide