Palindrome Precision H Chronic Catheter (Unknown) – Incorrect Heparin Coating (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP
Lot Codes / Batch Numbers
GTIN: 20884521158082, 10884521158085 Lot Number: 2228000089, 2201700103, 2228000074
Products Sold
GTIN: 20884521158082, 10884521158085 Lot Number: 2228000089, 2201700103, 2228000074
A medical device manufacturer is recalling Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin C due to Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Recommended Action
Per FDA guidance
Medtronic issued Urgent Medical Device Recall Letter on 3/15/24. Letter states reason for recall, health risk and action to take: 1.Immediately quarantine and discontinue use of unused affected product (see Attachment A). 2. Return all unused products from your inventory to Medtronic. Please contact: rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). a.Credit for the returned affected product will be issued based on the RGA number. b. If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. 3. In addition, please complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory. 4. This notice should be passed on to those who need to be aware within your organization or to any organization including, but not limited to, nephrologists, intensivists, implanting and managing physicians, renal nurses, critical care nurses, or other dialysis staff where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. If you have questions regarding this communication, please contact your local representative or Customer Service at 800-962-9888, option 2 (Monday Friday 8:00 a.m. to 6:30 p.m.).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026