ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN
Lot Codes / Batch Numbers
Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047, 5282885, and 5834997.
Products Sold
Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047, 5282885, and 5834997.
A medical device manufacturer is recalling ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model due to ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.
Recommended Action
Per FDA guidance
Consignees were sent a "Medical Device Recall" letter dated 7/1/08. The letter described the product, problem and action to be taken. The letter also requested to complete and return The Field Action Reconciliation Form. For further information, please contact Customer Service at 800-716-6700.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WV, WI
Page updated: Jan 10, 2026