Open, Classified

DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

FDA Recall Z-2504-2021 · Posted None

Recalling FirmMedtronic Perfusion Systems

Recall StatusOpen, Classified

Product CodeDRA

Date Initiated2021-08-24

Product Quantity51,494 units

Reason for Recall

Potential for a wire protrusion through the left heart vent catheter tip

Firm Action

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 [email protected]. 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K834352ADULT VENT CATHETERDlp, Inc. · 1984-01-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.