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 case. This 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 |
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S20361 | S21905 | S22496 | S24759 | S28539 |
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S20361X1 | S21906 | S22497 | S25171 | S28555 |
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S20362 | S21940 | S22498 | S25393 | S28587 |
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S20362X1 | S21973 | S22598 | S25536 | S28796 |
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S20452 | S22005 | S22613 | S25618 | S29034 |
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S20501 | S22019 | S22614 | S25647 | S29035 |
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S20501X1 | S22020 | S22670 | S26047 | S29527 |
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S20502 | S22057 | S22677 | S26219 | S29659 |
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S20502X1 | S22088 | S22739 | S26480 | S29660 |
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S20503 | S22094 | S22739X1 | S26969 | S29934 |
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S20504 | S22095 | S22754 | S26970 | S30137 |
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S20971 | S22096 | S22871 | S27089 | S30427 |
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S20980 | S22107 | S22880 | S27367 | S30428 |
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S21218 | S22108 | S22890 | S27368 | S30519 |
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S21218X1 | S22235 | S22908 | S27369 |
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S21244 | S22236 | S22939 | S27466 |
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S21270 | S22237 | S22950 | S27587 |
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S21720X1 | S22237X1 | S22980 | S27631 |
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S21271 | S22238 | S23012 | S27632 |
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S21272 | S22239 | S23163 | S27647 |
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S21273 | S22240 | S23380 | S27767 |
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S21278 | S22241 | S23400 | S27768 |
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S21571 | S22242 | S23401 | S27772 |
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S21828 | S22243 | S23449 | S27953 |
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S21903 | S22246 | S23454 | S27966 |
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Catalog Numbers:
XD252500 | XD252507 | FCL-127-02 | FCL-127-09 |
XD252501 | XD252508 | FCL-127-03 |
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XD252502 | XD252509 | FCL-127-04 |
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XD252503 | TF8-38-62-5 | FCL-127-05 |
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XD252504 | TF8-38-62-B1 | FCL-127-06 |
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XD252505 | FCL-127-00 | FCL-127-07 |
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XD252506 | FCL-127-01 | FCL-127-08 |
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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.
Notes to Editors