DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- August 24, 2021
- Recall Number
- Z-2504-2021
- Quantity
- 51,494 units
- Firm Location
- Brooklyn Park, MN
Reason for Recall
Potential for a wire protrusion through the left heart vent catheter tip
Distribution
Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, Colombia, Costa Rica, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Norway, Pakistan, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, Yemen.
Lot / Code Info
Model/Reference Number 12116, Lot Number (GTIN Number): 2018080039 (20643169086719), 2018091020 (20643169086719), 2018100911 (20643169086719), 2018111023 (20643169086719), 2018111419 (20643169086719), 2019120925 (20643169086719), 2018080039 (00673978462943), 2018091020 (00673978462943), 2018100911 (00673978462943), 2018111023 (00673978462943), 2018111419 (00673978462943), 2018120581 (20643169086719), 2018120581 (00673978462943), 2018120582 (20643169086719), 2018120582 (00673978462943), 2018121084 (20643169086719), 2018121084 (00673978462943), 2019010456 (20643169086719), 2019010456 (00673978462943), 2019010764 (20643169086719), 2019010764 (00673978462943), 2019020136 (20643169086719), 2019020136 (00673978462943), 2019020368 (20643169086719), 2019020368 (00673978462943), 2019020758 (20643169086719), 2019020758 (00673978462943), 2019030720 (20643169086719), 2019030720 (00673978462943), 2019031167 (20643169086719), 2019031167 (00673978462943), 2019040262 (20643169086719), 2019040262 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Expiration date range: 09/30/2020 - 05/19/2024
Root Cause
Process control
Action Taken
On about 08/24/2021, Medtronic notified customers via 2-day tracked mail letter titled, "URGENT MEDICAL DEVICE RECALL DLP Left Heart Vent Catheters." The letter instructed customers identify and quarantine all affected DLP Left heart Vent Catheters, return all unused affected product in inventory to Medtronic by contacting Medtronic Customer Service at 1-800-854-3570 and to contact your local Medtronic Representative can assist you in the return of this product, and complete and return the provided Customer Confirmation Form and email to rs.cfqfca@medtronic.com. Additional instructions included to notify anyone within your organization that should be aware or to any organization where the potentially affected devices have been transferred.