—#178949

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

FDA product code: LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K120660
Affected lot / code info: Lot Number REDQ3444 Exp: 02/28/2022

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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 do the following: 1. Our records show that your facility has purchased the product code affected by this voluntary recall. Do not use or further distribute any affected product. 2. Please check all inventory locations within your institution for the affected product code / lot number combination listed in the recall notice. If you have further distributed this product code / lot number, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from your shelves. 4. If you have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Email the completed Recall and Effectiveness Check Form to BDPI.CustomerSupportCenter@bd.com or fax it to BPV at 1-800-994-6772. 7. Once the Recall and Effectiveness Check Form has been completed and emailed to BDPI.CustomerSupportCenter@bd.com or faxed to BPV at 1-800-994-6772 and all information has been verified, the BPV C

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-08-14
Terminated: 2021-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178949. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.