Class 2 Device Recall Medela Vario 18 Vaccum Pump

• Date Initiated by Firm: April 25, 2008
• Date Posted: September 04, 2008
• Recall Status: Terminated on May 15, 2012
• Recall Number: Z-2168-2008
• Recall Event ID: 48612
• 510(K)Number: K061205
• Product Classification: Pump, Portable, Aspiration - Product Code BTA
• Product: Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450)
• Code Information: Serial #: 1163101 - 1163120
• FEI Number: 2182207
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 800 53rd Ave NE; PO Box 1250; Minneapolis MN 55440-1250
• For Additional Information Contact: 763-514-5174
• Manufacturer Reason for Recall: The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.
• FDA Determined Cause: Employee error
• Action: Affected customers contacted by letter "Medtronic Urgent: Medical device Recall April 2008" that indicates that some Medela Vario 18 Vacuum Pumps were provided with an incorrect Suction Jar Lid that did not have the correct Conical Connection for the Vacuum Tube and the method to obtain a replacement part if needed. The letter requires customers to locate the Vacuum Pump serial number and compare it against the Serial Number on the Reply Form provided. Next customers are to review the Suction Jar Lid and check the part number. "Reply form and Instruction for Receiving Replacement Lid " included. Contact Medtronic 1-800-707-0933 for assistance.
• Quantity in Commerce: 1500 pumps (20 affected)
• Distribution: USA including states of OH, DE, CT, KY, AR, NY, MA, CA, GA, NC, MI, WI, TX, PA, MD, and country of CANADA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BTA