Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using eth

FDA device recall Z-2224-2017 · posted 2017-05-22 · Terminated

Recall details

Recalling firm

Vascular Solutions, Inc.

Reason for recall

Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI determined that material used in catheter construction may detach from within the lumen of the distal tip during use.

Action taken

The firm, Vascular Solutions, sent an "URGENT: Medical Device Recall" letter dated April 25, 2017, to all affected consignees. The letter described the problem and the product involved in the recall and actions to be taken. Consignees were instructed to identify location of all unused product in your possession; immediately cease further use or distribution, remove any unused product , place it in a secure area, and complete and return the VSI Account Inventory Form by email to: customerservice@vascom or fax to (763)656-4251. VSI Customer Service Department will contact consignees for return authorization of the product. If you have any specific questions or concerns regarding this matter, please contact your local sales representative or call 763-656-4300.

Root cause

Process control

Status

Terminated

Product code

DQY

Quantity affected

13,551 (7,054 are unexpired)

Distribution

Worldwide Distribution - US (nationwide): including states of: AK, AL, AR, AZ, CA, CO, CT, DC,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, ME, MI, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH

Date initiated

2017-04-25

Date posted

2017-05-22

Date terminated

2019-11-05

Location

Maple Grove, MN

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