Medtronic, Inc. 7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted
Brand
Medtronic, Inc.
Lot Codes / Batch Numbers
Lot Number: 21111255
Products Sold
Lot Number: 21111255
Medtronic, Inc. is recalling 7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11 Percutaneous catheter introdu due to Failure to insert the guidewire through the 18 gauge introducer needle. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure to insert the guidewire through the 18 gauge introducer needle
Recommended Action
Per FDA guidance
Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation.
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
FL, IL
Page updated: Jan 10, 2026