HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 101

FDA device recall Z-0558-2014 · posted 2013-12-20 · Terminated

Recall details

Recalling firm

Abbott Vascular, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

DQX

Quantity affected

54,895 units total (5,356 units in US)

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Australia, French Guyana, Macedonia, South Korea, Austria, Germany, Malaysia, Spain, Bahrain, Greece, Martinique, Sweden, Belgium, Hong

Date initiated

2013-11-25

Date posted

2013-12-20

Date terminated

2014-07-14

Location

Temecula, CA