Z-0917-2020Class II

Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended...

Name: Z-0917-2020 Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended...
Creator: Bard Peripheral Vascular Inc
Published: 2019-08-14
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2019-08-14 / Terminated / root cause: labeling and UDI

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F... on 2019-08-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0917-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-14
Posted: 2020-01-30
Terminated: 2021-02-26
Recalling firm: Bard Peripheral Vascular Inc
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
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: 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 tag: labeling and UDI
FDA 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 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 [email protected] or fax it to BPV at 1-800-994-6772. 7. Once the Recall and Effectiveness Check Form has been completed and emailed to [email protected] or faxed to BPV at 1-800-994-6772 and all information has been verified, the BPV C
Quantity in commerce: 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
Product codes and lots: Lot Number REDQ3444 Exp: 02/28/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0917-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0917-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-05	2020-01-30

Product code LIT

K120660Class IIConquest 40 Pta Dilatation CatheterBard Peripheral Vascular, Inc. / cleared 2012-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)