Bard UltraClip breast tissue marker recall due to separation risk
Bard Peripheral Vascular is recalling UltraClip breast tissue markers because the metal marker may separate from the needle before use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product where the device may fail during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bard Peripheral Vascular (BPV) is recalling 3,085 units of the BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. The device is intended to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
The recall was initiated because some devices with the affected product code and lot number combinations may have the metal tissue marker separated from the needle prior to use. The affected lots are distributed worldwide, including the USA and Europe.
Healthcare providers and consumers should stop using the affected devices and contact Bard Peripheral Vascular for instructions on how to return them.
The recalled product
- Product
- BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 3,085
Distribution
Distributed nationwide across the United States.
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