Devices

Device Recall Vascular Solutions, Pronto V4, Extraction Catheter

Model / Serial
Model Lot # 4005 (5.5F) 551391 551513 551579 551861 4006(6F) 551034 551178 551514 551578 551581 551583 4007 (7F) 551106 551249 552116 4008 (8F) 551107551362 551577 552163
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, FL, ID, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK ,OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Product Description
Vascular Solutions, Pronto¿ V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall. || The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Manufacturer
Vascular Solutions, Inc.
1 Event
- Recall of Device Recall Vascular Solutions, Pronto V4, Extraction Catheter

Manufacturer

Vascular Solutions, Inc.

Manufacturer Address
Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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