CLASS II Device recall · Reported 24 Oct 2012 · FDA Enforcement Report

Leveen Coaccess Introducer Set recalled by Boston Scientific

Boston Scientific is recalling Leveen Coaccess Introducer Set. The recall was initiated on 17 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial Catalog Number: MOO1262250 with lot numbers: 12303537, 12304530, 12318677, 12376281, 12516197, 12526599, 12564932, 12863427, 12868931, 12900282, 13020097, 13075108, 13093464, 13131129, 13364410, 13487647, 13488797, 13489157, 13563682, 13600249, 13629070, 13659872, 13759829, 13767726, 13892916, 14024827, 14119996, 14141754, 14215317, 14218162, 14218163, 14218164, 14268381, and 14273987.

Quantity recalled19,716 units distributed total all products

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-0081-2013
FDA event ID: 63336
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 17 Sep 2012
FDA classified: 18 Oct 2012
Reported: 24 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

17 Sep 2012	Recall initiated by company
18 Oct 2012	Classified by FDA	+31 days
24 Oct 2012	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

Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.

Product as listed by the FDA

Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

Where it was distributed

Distributed in Brazil, Portugal and Hong Kong.

Questions about this recall

Is Leveen Coaccess Introducer Set recalled?

Yes. Boston Scientific recalled Leveen Coaccess Introducer Set on 17 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0081-2013.

Why was it recalled?

Which lots are affected?

Material Catalog Number: MOO1262250 with lot numbers: 12303537, 12304530, 12318677, 12376281, 12516197, 12526599, 12564932, 12863427, 12868931, 12900282, 13020097, 13075108, 13093464, 13131129, 13364410, 13487647, 13488797, 13489157, 13563682, 13600249, 13629070, 13659872, 13759829, 13767726, 13892916, 14024827, 14119996, 14141754, 14215317, 14218162, 14218163, 14218164, 14268381, and 14273987.

Where was it sold?

Distributed in Brazil, Portugal and Hong Kong.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

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