Abbott Vascular, Inc. Recalls

FDA
2
Total Recalls
1
Agencies
Feb 2008
First Recall
Jul 2014
Latest Recall

Showing 1-2 of 2 recalls

FDA

HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.

Abbott Vascular sent an Urgent Device Recall letter dated November A recall communication letter dated November 25, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. The letter informs the customers of the 9 part numbers and 9 description of the products. Abbott Vascular is instructing the customers that the returned products will be replaced with similar products pending availability. Abbott Vascular has attached a customer response form for customers along with the customer notification letter. For questions regarding this recall call 951-914-2400.

FDA

StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: Abbott Vascular Inc., 400 Saginaw Drive, Redwood City, CA 94063

Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.

On 1/31/07, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned to its sales rep.