Recalls / —

—#188977

Product

DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only

FDA product code: DRA — Catheter, Steerable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K834352
Affected lot / code info: Model/Reference Number 12118, Lot Number (GTIN Number): 2018080452 (20643169086702), 2018080452 (00673978462950), 2018090435 (20643169086702), 2018090435 (00673978462950), 2018100525 (20643169086702), 2018100525 (00673978462950), 2018111024 (20643169086702), 2018111024 (00673978462950), 2018111421 (20643169086702), 2018111421 (00673978462950), 2019020369 (20643169086702), 2019020369 (00673978462950), 2019030426 (20643169086702), 2019030426 (00673978462950), 2019031168 (20643169086702), 2019031168 (00673978462950), 2019041190 (20643169086702), 2019041190 (00673978462950), 2019060424 (20643169086702), 2019060424 (00673978462950), 2019070714 (20643169086702), 2019070714 (00673978462950), 2019070715 (20643169086702), 2019070715 (00673978462950), 2019080686 (20643169086702), 2019080686 (00673978462950), 2019081292 (20643169086702), 2019081292 (00673978462950), 2019090394 (20643169086702), 2019090394 (00673978462950), 2019091081 (20643169086702), 2019091081 (00673978462950), 2019100159 (20643169086702), 2019100159 (00673978462950), 2019101446 (20643169086702), 2019101446 (00673978462950), 2019111051 (20643169086702), 2019111051 (00673978462950), 2019120418 (20643169086702), 2019120418 (00673978462950), 2020010051 (20643169086702), 2020010051 (00673978462950), 2020010446 (20643169086702), 2020010446 (00673978462950), 2020020094 (20643169086702), 2020020094 (00673978462950), 2020020764 (20643169086702), 2020020764 (00673978462950), 2020021113 (20643169086702), 2020021113 (00673978462950), 2020040403 (20643169086702), 2020040403 (00673978462950), 2020041125 (20643169086702), 2020041125 (00673978462950), 2020041431 (20643169086702), 2020041431 (00673978462950), 2020050353 (20643169086702), 2020050353 (00673978462950), 2020050919 (20643169086702), 2020050919 (00673978462950), 2020060370 (20643169086702), 2020060370 (00673978462950), 2020060673 (20643169086702), 2020060673 (00673978462950), 2020070374 (20643169086702), 2020070374 (00673978462950), 2020080075 (20643169086702), 2020080075 (00673978462950), 2020120620 (20643169086702), 2020120620 (00673978462950), 2021010035 (20643169086702), 2021010035 (00673978462950), 201906C177 (20643169086702), 201906C177 (00673978462950), 2017090238 (00673978462950), 2018080450 (20643169086702), 2018080451 (20643169086702), 2018090065 (20643169086702), 2018091021 (20643169086702), 2018100523 (20643169086702), 2018100524 (20643169086702), 2018120893 (20643169086702), 2019010457 (20643169086702), 2019010765 (20643169086702), 2019011214 (20643169086702), 2019020007 (20643169086702), 2019030064 (20643169086702), 2019030065 (20643169086702), 2019030721 (20643169086702), 2019031169 (20643169086702), 2019040844 (20643169086702), 2019040845 (20643169086702), 2019040846 (20643169086702), 2019041191 (20643169086702), 2019050167 (20643169086702), 2019050577 (20643169086702), 2019050846 (20643169086702), 2019051127 (20643169086702), 2019060219 (20643169086702), 2019060220 (20643169086702), 2019060687 (20643169086702), 2019060985 (20643169086702), 2019060986 (20643169086702), 2019070613 (20643169086702), 2019071115 (20643169086702), 2019081002 (20643169086702), 2019090072 (20643169086702), 2019090393 (20643169086702), 2019091025 (20643169086702), 2019100418 (20643169086702), 2019101095 (20643169086702), 2019110084 (20643169086702), 2019111050 (20643169086702), 2019120927 (20643169086702), 2020010052 (20643169086702), 2020011621 (20643169086702), 2020020472 (20643169086702), 2020030065 (20643169086702), 2020050354 (20643169086702), 2020050700 (20643169086702), 2020060067 (20643169086702), 2020060068 (20643169086702), 2020060964 (20643169086702), 2020060965 (20643169086702), 2020070055 (20643169086702), 2020070655 (20643169086702), 2020070969 (20643169086702), 2020071273 (20643169086702), 2020081034 (20643169086702), 2020090632 (20643169086702), 2020110762 (20643169086702), 2020120079 (20643169086702), 2020120621 (20643169086702), 2021010553 (20643169086702), 2021011168 (20643169086702), 2021011169 (20643169086702), 2021011170 (20643169086702), 2021031116 (20643169086702), 2021031308 (20643169086702), 2021031309 (20643169086702), 2021040093 (20643169086702), 2021040871 (20643169086702), 2021041149 (20643169086702), 2021050635 (20643169086702), 201901C051 (20643169086702), 201903C128 (20643169086702), 201905C013 (20643169086702), 201906C176 (20643169086702), 202011C198 (20643169086702), 202106C012 (20643169086702), 202106C013 (20643169086702), 202106C014 (20643169086702), 202106C020 (20643169086702), 202106C021 (20643169086702). Expiration date range: 09/30/2020 - 05/19/2024

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

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.

Timeline

Recall initiated: 2021-08-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188977. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.