—#71725

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)

FDA product code: BTA — Pump, Portable, Aspiration (Manual Or Powered)
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K061205
Affected lot / code info: Serial #: 1163101 - 1163120

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250

Distribution

Distribution pattern: USA including states of OH, DE, CT, KY, AR, NY, MA, CA, GA, NC, MI, WI, TX, PA, MD, and country of CANADA.

Timeline

Recall initiated: 2008-04-25
Posted by FDA: 2008-09-04
Terminated: 2012-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71725. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.