Z-1634-2024Class II

Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin...

Name: Z-1634-2024 Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin...
Creator: Covidien LP
Published: 2024-03-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-03-15 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LP began a recall of Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet-... on 2024-03-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1634-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-15
Posted: 2024-04-24
Recalling firm: Medtronic, Inc.
Product: Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected] 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 [email protected] 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.).
Quantity in commerce: 305 units
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.
Product codes and lots: GTIN: 20884521157733 Lot Number: 2318500118

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1634-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1634-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24
Z-1635-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24

Product code MSD

K123196Class IIPalindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter, Palindrome Precision Hsi Chronic CathCovidien / cleared 2013-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)