Teleflex Incorporated Announces Worldwide Recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
WAYNE, Pa.--(BUSINESS WIRE)--
Teleflex Incorporated (TFX) announces worldwide recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. The Arrow® IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart.
Teleflex Incorporated announced today that the U.S. Food and Drug Administration (FDA) has classified the recall of ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits as a Class I recall. FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
On 9-Feb-2016, Teleflex Incorporated initiated a worldwide recall of 47,140 units distributed to hospitals, clinics, and medical centers throughout the United States and globally. The ARROW® International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits are being recalled because the sheath body may become separated from the sheath hub. If the separation occurs, the patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss or exsanguination may occur. Interruption or loss of intra-aortic balloon pump treatment may also occur. At the time of the recall, there were 13 adverse events reported; including 6 serious injuries and 1 death.
Teleflex notified domestic distributors and customers via an Urgent Medical Device recall letter dated February 11, 2016. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.
Teleflex has notified the FDA of this action.
See table below for affected product codes. A full list of affected lot numbers can be found in the appendix to this notification.
| PRODUCTS AFFECTED | |||||
| Product Code | Lot | ||||
| IAB-05830-LWS | Reference Appendix | ||||
| IAB-05830-U | |||||
| IAB-05840-LWS | |||||
| IAB-05840-U | |||||
| IAB-06830-U | |||||
| IAB-06840-U | |||||
| IAB-S730C | |||||
| IAK-06845 | |||||
| IAK-S7IT | |||||
The original recall notice can be found at Teleflex’s website: http://www.teleflex.com/en/recall/Customer_letter_and_form_press_release.pdf
Consumers with questions may contact the company at 1-866-246-6990; 8am to 8pm, ET, Monday through Friday or at recalls@teleflex.com.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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