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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

ev3 Initiates Voluntary Recall of Specific Lots of NanoCross™ .014" OTW PTA Dilatation Catheter
 

Contacts:
Rachel Bloom Baglin
Vice President, Communications
Vascular Therapies
508-261-6651
rachel.bloombaglin@covidien.com
 

Bruce Farmer
Vice President
Public Relations
508-452-4372
bruce.farmer@covidien.com
 

Cole Lannum, CFA
Vice President
Investor Relations
508-452-4343
cole.lannum@covidien.com
 

FOR IMMEDIATE RELEASE – Plymouth, MN – December 23, 2010 - ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross™ .014" OTW PTA Dilatation Catheter due to the potential for the catheter shaft to crack or break during use. Cracking or breaking of the catheter shaft may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization. The device failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, tissue, injury, infarct, bleeding and/or death.  The Food and Drug Administration (FDA) has classified the recall as a Class I recall.  FDA classifies a recall as Class I when the agency believes there is a reasonable probability that the use of the recalled product will cause serious adverse health consequences or death.

The NanoCross 0.014" OTW PTA Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.  The NanoCross Dilatation Catheter is not an implant.  It is removed and discarded after the procedure is completed.

The voluntary recall affects certain lots of the NanoCross .014" OTW PTA Dilatation Catheters manufactured between May 27, 2010, and October 18, 2010.  Only the NanoCross .014" OTW PTA Dilatation Catheters from lot numbers listed below is affected by this action.  All affected healthcare facilities have been notified of this action in a letter dated November 10, 2010. Healthcare facilities should take immediate action to locate and remove from use the specified NanoCross PTA Dilatation Catheters.  Detailed steps were provided in the Customer Notification letter for return and disposition of affected products. 

Affected ev3 NanoCross™ .014" OTW PTA Dilatation Catheter Product Catalog / Lot Numbers 

Cat. # AB14W020040150

Lot Numbers:

8631564

8664386

8703047

8743036

8745610

8749903

8784866

8792531

8821432

8837969

8847440

8871669

9209927

Cat. # AB14W020080150

Lot Numbers:

8672990

8710423

8778807

8778808

8789928

8811586

8837970

9153521

9222820

Cat. # AB14W020120150

Lot Numbers:

8672994

8755401

8755602

8755604

8784858

8795999

8810475

9023725

9050028

9074214

9088260

9146365

9198871

9209680

9235823

9248597

9254604

9266768

Cat. # AB14W020150150

Lot Numbers:

8746781

8784859

8798136

8827211

8851945

8964937

 

 

 

 

 

 

 

Cat. # AB14W020210150

Lot Numbers:

8778745

8778748

8778749

8789891

8810468

8821428

9097151

9195071

9214883

9216811

9221177

9231361

9238413

Cat. # AB14W025040150

Lot Numbers:

8746902

8746903

8749908

8784864

8810470

8826743

8846663

8915544

8985597

9235612

Cat. # AB14W025080150

Lot Numbers:

8664384

8711789

8741778

8778813

8796007

8821434

8846664

9218102

9232283

Cat. # AB14W025120150

Lot Numbers:

8722274

8722275

8722277

8741791

8745616

8815365

8815410

9013770

9023719

9082516

9097149

9178997

9222934

9254886

9270248

 


Cat. # AB14W025150150

Lot Numbers:

8789931

8810473

8827208

8854221

8877645

8989919

9237414

Cat. # AB14W025210150

Lot Numbers:

8744140

8757219

8826331

8826333

8826336

9082532

9155514

9180316

9209447

9222907

9233059

9238795

Cat. # AB14W030040150

Lot Numbers:

8630847

8703042

8703044

8703050

8737491

8741794

8755622

8789946

8796008

8841532

8842327

8847442

8871667

8916474

8985601

9217289

9221183

Cat. # AB14W030080150

Lot Numbers:

8674379

8710383

8745612

8757468

8795994

8816902

8838736

9153523

9203512

9221180

9232658

9237412

 

Cat. # AB14W030120150

Lot Numbers:

8711873

8741781

8755603

8784854

8792133

8810472

9023729

9062683

9097148

9179000

9224585

9231360

9248574

9254782

9286411

Cat.# AB14W030150150

Lot Numbers:

8741786

8749899

8789924

8810474

8836819

8871664

8970944

Cat.# AB14W030210150

Lot Numbers:

8815676

8816203

8816467

8821338

8821419

8836748

8847435

9083740

9148256

9194250

9216747

9221182

9235807

9263491

Cat.# AB14W035040150

Lot Numbers:

8705822

8784860

8853567

8989918

Cat.# AB14W035080150

Lot Numbers:

8757061

8815414

9078466

9248425

Cat.# AB14W035120150

Lot Numbers:

8703049

8815409

9078464

9208441

9286249

Cat.# AB14W035150150

Lot Numbers:

8822758

Cat.# AB14W035210150

Lot Numbers:

8789883

8828189

9208439

9221817

Cat.# AB14W040040150

Lot Numbers:

8629968

8657024

8755600

8755601

8755625

8789935

8821431

8842537

8877650

8970943

9209903

Cat.# AB14W040080090

Lot Numbers:

9220075

9225648

Cat.# AB14W040080150

Lot Numbers:

8722279

8749882

8787509

8822999

9216848

9224246

9237413

Cat.# AB14W040120150

Lot Numbers:

8738444

8749895

8778810

8789939

8822880

9000723

9018516

9097147

9194251

9204433

9248553

9263037

9283623

Cat.# AB14W040210150

Lot Numbers:

8741777

8751214

8784853

8810467

8822411

8836749

9235780

9245449

Cat.# AB14W040150150

Lot Numbers:

8747184

8796001

8837761

8873813

 

 

The lot numbers for all NanoCross .014” OTW PTA Dilatation catheters are clearly printed on the front and sides of the product packaging.

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone. 

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