Greatbatch Recalls ViaPeel Introducer Sheaths Due to Handle Detachment
Greatbatch Medical is recalling 5,000 ViaPeel PTFE Peelable Introducer 5FR devices because handles may detach during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical failure (handle detachment) that poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Greatbatch Medical is recalling 5,000 units of the ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006. The recall is due to reports that the handles on these devices may detach during use.
The affected devices are identified by Lot Number W3101005. The distribution pattern is listed as NY, indicating the devices were distributed in New York.
Healthcare providers and patients should stop using the affected devices and contact Greatbatch Medical for further instructions or a replacement.
The recalled product
- Product
- ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
- Manufacturer
- Greatbatch Medical
- Hazard
- Affected units
- 5,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: W3101005
Distribution
Distributed in 1 state:
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