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Thomas Medical Products Initiates Worldwide Recall Of Safesheath® CSG® Sheath Introducer

January 29, 2010

MALVERN, PA – January 29, 2010 – Thomas Medical Products (TMP) formally announced today a worldwide voluntary recall of the SafeSheath® CSG® Sheath Introducer due to reported fragmentation and embolization of the radiopaque (RO) soft tip during use due to material degradation.   

SafeSheath® CSG® Sheath Introducer is a hemostatic introducer system with infusion side port that is intended for the introduction of various types of pacing or defibrillator leads, developed and manufactured by Thomas Medical Products, and distributed by Pressure Products, Inc. (PPI).

To date, TMP has received 38 adverse event reports in which the SafeSheath CSG introducer tip became separated.  In situations where this occurs in a patient with a cardiac septal defect or a patent foramen ovale (PFO), the sheath tip fragment could potentially pass from the right into the left cardiac chambers and systemic arterial circulation.  From there, the fragmented tip could embolize to any part of the body, including a vital structure such as the brain or heart, leading to permanent injury such as stroke or myocardial infarction.  This recall is intended to minimize future occurrences and adverse events.

TMP and PPI are notifying all customers about this recall through notices sent to each customer.  TMP and PPI are also arranging for return of all unused products.  Customers with questions may contact TMP at 1-866-466-3003 or tmpinfo@ge.com, between the hours of 8:30 AM to 5:00 PM EST. 

The recall encompasses products distributed from December 1, 2005 to December 14, 2009 and includes the following lot ranges and catalog numbers:

Lot Numbers:

S16176

S18974

S20331

S23021

S24852

S25807

S27504

S29767

S17215

S19051

S20491

S23022

S24906

S25896

S27610

S29813

S17216

S19060

S20494

S23052

S24907

S26039

S27611

S29823

S17248

S19135

S20505

S23092

S24931

S26039X1

S27617

S29879

S17349

S19153

S20704

S23103

S24951

S26040

S27646

S30059

S17447

S19161

S20713

S23111

S24956

S26040X1

S27670

S30257

S17448

S19173

S20848

S23112

S24958

S26088

S27876

S30060

S17449

S19174

S21002

S23225

S24978

S26095

S27895

S30258

S17478

S19175

S21071

S23384

S25050

S26183

S27913

S99009X1

S17596

S19196

S21115

S23387

S25051

S26183X1

S27914

S99010X1

S17640

S19262

S21128

S23388

S25052

S26345

S27924

S99011X1

S17675

S19264

S21236

S23402

S25082

S26554X1

S27952

S99052X1

S17789

S19290

S21557

S23403

S25097

S26570X1

S28054

S27349

S17790

S19291

S21650

S23492

S25121

S26571X1

S28214

S27401

S17795

S19292

S21651

S23507

S25140

S26576

S28215

 

S17864

S19409

S21652

S23508

S25141

S26635X1

S28232

 

S18000

S19428

S21695

S23543

S25142

S26636X1

S28272

 

S18004

S19450

S22085

S23618

S25239

S26637X1

S28273

 

S18290

S19564

S22160

S23795

S25241

S26752

S28283

 

S18291

S19742

S22216

S23926

S25323

S26754

S28326

 

S18336

S19743

S22228

S23927

S25324

S26833

S28360

 

S18337

S19756

S22229

S23956

S25353

S26834

S28391

 

S18352

S19757

S22244

S24026

S25404

S26912

S28460

 

S18529

S19906

S22282

S24027

S25433

S27030

S28485

 

S18535

S19959

S22302

S24101

S25469

S27031

S28564

 

S18593

S19961

S22367

S24174

S25486

S27032

S28576

 

S18670

S19966

S22368

S24175

S25487

S27056

S28731

 

S18725

S19991

S22371

S24341

S25494

S27057

S28808

 

S18736

S20007

S22396

S24353

S25497

S27186

S28894

 

S18744

S20019

S22397

S24354

S25590

S27241

S28939

 

S18745

S20101

S22491

S24355

S25590X1

S27242

S29270

 

S18861

S20154

S22675

S24619

S25594

S27321

S29492

 

S18862

S20170

S22676

S24620

S25720

S27325

S29669

 

S18952

S20297

S22746

S24772

S25721

S27434

S29736

 

S18962

S20298

S23020

S24800

S25806

S27503

S29766

 

Catalog Numbers:

CSG/MSP-00-09

CSGWORLEY109M

CSG/90-09

CSGWORL19M

CSG-KR-90-09

CSGWORBC19M

CSG/WORLEY-1-09

CSGWORLBC19M

CSG-WORLEY-Bcor-1-09

CSGWORBC29M

CSG/WORLEY/L/Bcor-1-09

CSG/Worley/BCor-1-07

CSG/WORLEY-2-09

CSG/Worley/BCor-2-07

CSG/WORLEY/Bcor-2-09

CSG/WORLEY/BCOR-M-09

CSGMSP0009M

CSG/Worley/R-1-09

TMP has informed the U.S. Food and Drug Administration (FDA) of this action.  Any adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178


Contact Information

Autumn Latimore
Name
Autumn Latimore
Job Title
Division
GE Healthcare
Phone
4147214013
Fax
Mobile
2624972753
Email
Autumn.Latimore@ge.com