Bard Conquest 40 PTA Dilation Catheter Recalled for Packaging Error
Bard Peripheral Vascular Inc. is recalling 286 units of Conquest 40 PTA Dilation Catheters because packaging incorrectly listed the balloon size, posing a risk of vessel injury.
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 injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling 286 units of Bard Conquest 40 PTA Dilation Catheters (Lot REDQ3444, Exp: 02/28/2022). The recall involves two specific configurations: 8mm X 20mm x 75cm (CQF7582) and 8mm x 40mm x 75cm (CQF7584). The products were distributed to facilities in 35 US states, the District of Columbia, and Puerto Rico.
The recall was initiated because the catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size of 8mm X 40mm. If this labeling error is not detected by the medical user, the longer-than-expected balloon may be advanced to the lesion. Upon inflation, this could result in the dilation of non-diseased vessels, kidneys, or sections of AV dialysis fistulae, potentially causing varying degrees of injury that may require additional medical or surgical intervention.
No specific illnesses or injuries have been reported in the source text. Healthcare facilities and consumers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 286
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 REDQ3444 Exp: 02/28/2022
Distribution
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