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Thomas Medical Products Initiates Worldwide Recall Of Transseptal Sheath Introducer Kits

February 23, 2010

MALVERN, PA – FEBRUARY 23, 2010 – Thomas Medical Products (TMP) formally announced today a worldwide voluntary recall of the Transseptal Sheath Introducer Kits (tradenames:  HeartSpan™, CHANNEL FX, Torflex, Braided Transseptal Guiding Introducer Kit) due to reports of the sheath tip breaking off and separating while the sheath is in blood vessels, in use for cardiac procedures. 

The affected sheaths are used to pass heart catheters from the right to the left side of the heart by crossing the middle heart wall, or septum.  If the sheath tip breaks off during this procedure, the fragment could move, or embolize, through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart.  This could lead to permanent injury, such as a stroke or heart attack.

To date, TMP has received five (5) adverse event reports in which the transseptal sheath introducer tip became fragmented/separated.   These five occurrences were reported to affect health ranging from no clinical significance in four cases to tip fragment embolization in a coronary artery in the fifth caseThis recall is intended to minimize future sheath breakage and adverse events.

TMP is notifying all customers about this recall through notices sent to each customer.  TMP is 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 October 1, 2006 to December 28, 2009 and includes the following lot ranges and catalog numbers:

 

Lot Numbers:

25346

S21904

S22495

S24213

S28055





S20361

S21905

S22496

S24759

S28539





S20361X1

S21906

S22497

S25171

S28555





S20362

S21940

S22498

S25393

S28587





S20362X1

S21973

S22598

S25536

S28796





S20452

S22005

S22613

S25618

S29034





S20501

S22019

S22614

S25647

S29035





S20501X1

S22020

S22670

S26047

S29527





S20502

S22057

S22677

S26219

S29659





S20502X1

S22088

S22739

S26480

S29660





S20503

S22094

S22739X1

S26969

S29934





S20504

S22095

S22754

S26970

S30137





S20971

S22096

S22871

S27089

S30427





S20980

S22107

S22880

S27367

S30428





S21218

S22108

S22890

S27368

S30519





S21218X1

S22235

S22908

S27369







S21244

S22236

S22939

S27466







S21270

S22237

S22950

S27587







S21720X1

S22237X1

S22980

S27631







S21271

S22238

S23012

S27632







S21272

S22239

S23163

S27647







S21273

S22240

S23380

S27767







S21278

S22241

S23400

S27768







S21571

S22242

S23401

S27772







S21828

S22243

S23449

S27953







S21903

S22246

S23454

S27966







 

Catalog Numbers:

XD252500

XD252507

FCL-127-02

FCL-127-09

XD252501

XD252508

FCL-127-03



XD252502

XD252509

FCL-127-04



XD252503

TF8-38-62-5

FCL-127-05



XD252504

TF8-38-62-B1

FCL-127-06



XD252505

FCL-127-00

FCL-127-07



XD252506

FCL-127-01

FCL-127-08





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.

 

Contact Information

Veronica Botet
Name
Veronica Botet
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Division
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Veronica.Botet@ge.com