Abbott Recalls HT Connect Peripheral Guide Wires Due to Coating Delamination
Abbott Vascular is recalling HT Connect Peripheral Guide Wires because a small number of devices show partial delamination of the PTFE coating.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abbott Vascular, Inc. has initiated a recall of the HT Connect Peripheral Guide Wires. The recall is due to a small number of devices exhibiting partial delamination of the PTFE coating.
The affected products include various lengths and types of HT Connect and HT Connect Flex guide wires, identified by specific part numbers and lot numbers. A total of 54,895 units were distributed, with 5,356 units distributed in the United States and the remainder distributed internationally to numerous countries.
Healthcare providers and patients should check their inventory and records for the specific part numbers and lot numbers listed in the official recall notice. If a device is found to be affected, it should be removed from service and returned to Abbott Vascular according to their instructions.
The recalled product
- Product
- 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
- Manufacturer
- Abbott Vascular, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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