Open, Classified

Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

FDA Recall Z-1314-2022 · Posted 2022-07-07

Recall StatusOpen, Classified

Product CodeMSD

Date Initiated2022-06-08

Product Quantity2,462 units

Reason for Recall

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Firm Action

Medtronic distributed a recall notification to customers by mail on 06/08/2022. Customers were instructed to immediately quarantine and discontinue use for specific lots of chronic hemodialysis catheters, which are to be returned to Medtronic. If customers have further distributed product, they are asked to forward the information from the recall notification to those recipients. All customers are asked to complete and return the Consignee Product Retrieval Confirmation Form to [email protected]. Additionally, consignees are asked to share the notice within their organization and retain it for their records regarding the retrieval of unused product. If a consignee is aware of any adverse events associated with recalled product, they are to submit a report to FDA via Medwatch. Customers with any questions can contact their Medtronic Representative or call Customer Service at 800-962-9888, option 2. ***Updated 8/16/22*** Medtronic has created a website to help customers identify affected product: https://www.medtronic.com/covidien/en-us/products/c/renal-care-recall-lookup-tool.html#lotLookupTool

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123196PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATHCovidien · 2013-01-31

Official Source

View FDA Recall →

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