Bard Nautilus Delta Port Kits Recalled for ECG Signal Loss
Bard Peripheral Vascular is recalling specific Nautilus Delta Port Kits due to a risk of losing the intravascular ECG signal during placement procedures.
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 is classified as FDA Class II, and the hazard involves a risk of harm (loss of ECG signal during a medical procedure) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 95 units of specific POWERPORT CLEARVUE and NAUTILUS DELTA Port Kit combinations. The affected products include 6F and 8F CHRONOFLEX Catheters and the NAUTILUS DELTA Tip Confirmation System. These devices are implantable access devices designed to provide repeated access to the vascular system.
The recall was initiated because certain product code and lot number combinations may experience a lack of or loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA Tip Confirmation System. The affected units were distributed nationwide in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI, and VA.
Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further information regarding the recall and potential replacement or repair options. The specific affected lot numbers are REBR1147, REBR1148, REBR1149, REBT0471, RECQ2162, and REBR1150.
The recalled product
- Product
- POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT…
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 95
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 (5)
- REBR1147
- REBR1148
- REBR1149
- REBT0471
- RECQ2162 and REBR1150
Distribution
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