FREMONT, Calif.--()--On November 15, 2010 AngioScore Incorporated initiated a worldwide recall of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018” OTW, balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm. This recall was initiated because of a small number of reports from the field of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element, wherein the proximal end of the scoring element remains secured to the catheter. Retained device fragments or significant arterial injury due to device failure may occur which may lead to death, need for percutaneous catheter-based interventions to remove retained device fragments, increased exposure to anesthesia, and loss of limb. There have been no reported injuries related to this failure mode to date.
The company estimates that 14,775 affected products have been distributed in the United States and 2,907 affected products have been distributed outside the United States. FDA has classified this action as a Class I recall, meaning that FDA believes the use of this product may cause serious adverse health consequences or death.
This voluntary recall does not affect the AngioSculpt PTCA catheters, or any AngioSculpt PTA catheter balloon sizes (in millimeters): 0.014” OTW, 2.0x10, 2.0x20, 2.5x20, 3.0x20, 3.5x20; and 0.018”OTW, 4.0x40, 5.0x40, 6.0x40.
The recall includes the following model numbers and lot numbers:
|Part (REF) Number||Product Description||Lot Numbers|
|2076-4020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018” Platform, 137 cm, 4.0mmx20mm balloon size||All|
|2076-5020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018” Platform, 137 cm, 5.0mmx20mm balloon size||All|
|2076-6020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018” Platform, 137 cm, 6.0mm x20mm balloon size||All|
|2092-6020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018” Platform, 90 cm, 6.0mmx20mm balloon size||All|
|2105-6020||AngioSculpt PTA Scoring Balloon Catheter, OTW 0.018” Platform, 50 cm, 6.0mmx20mm balloon size||All|
AngioScore has notified the hospitals that have received the recalled product and has instructed these hospitals to cease the use of affected product and return the affected product to AngioScore.
The firm voluntarily recalled the products after observing the failure modes during bench top testing. FDA has been apprised of this action.
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.
- 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
Consumers with questions may contact AngioScore at 1-877-264-4692, Monday through Friday from 8:00 am to 5:00 pm Pacific Time.