Recall Z-0917-2020 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Bard Peripheral Vascular Inc
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
| Date | Aug 14, 2019 |
| Status | Terminated |
| Reason | The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention. |
| Root cause | Labeling mix-ups |
| Action | On 8/14/2019, a "Urgent Medical Device Recall Notification was sent to consignees via FedEx. Shortly after sending the original customer letter on 08/14/2019, the firm realized that customers may experience issues identifying the affected Lot Number in their inventory if they searched by the Product Code CQF7584. On 9/10/2019, the firm sent a 2nd notice explaining that although CQF7584 is the affected Product Code that they purchased, the actual Product Code listed on the package labeling is CQF7582. In addition to providing details about the recall products, the notification ask customer to d |
| Quantity | 286 Units |
| Distribution | US: NJ, NY, OH, PA, VA, SC, GA, AR, TX, MA, NC, TN, LA, AZ, MS, FL, AL,MD, CA, HI, MO, CO, WI, DC, KY, IL, MN, IN, KS, OK, CT, MT, WA, ND, IA, WA, WV, PR OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120660 | CONQUEST 40 PTA DILATATION CATHETER Bard Peripheral Vascular, Inc., Mar 15, 2012 |