Agency classClass IOur severity:Severe FDA (Devices)·Z-1312-2022·Announced 2022-07-13

Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk

Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall carries an FDA Class I designation, which mandates a minimum severity level of 4. Although no illnesses or injuries have been reported, the potential for fluid leakage in a critical dialysis access device poses a direct risk to patient safety during essential treatment.

Plain-English summary

Covidien LLC is recalling Palindrome Precision Chronic Catheters, sterile single-use medical devices intended for vascular access in acute and chronic hemodialysis, apheresis, and infusion therapy. The company has identified a potential leaking condition within the hub component of certain catheters due to an internal void between the lumens.

During use, this inter-lumen void may cause unanticipated fluid to return or escape from the device. This leaking condition could compromise the safety and effectiveness of treatment.

Approximately 213,589 affected units have been distributed worldwide, including throughout all U.S. states and territories, as well as internationally. Healthcare providers and patients should discontinue use of affected catheters and consult with their medical team regarding alternative vascular access options.

The recalled product

Product: Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Manufacturer: Covidien Llc
Category: Medical Device — Vascular Access / Dialysis
Hazard: device-leak
hub-defect
Affected units: 213,589

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Code Information organized as "Model No.
Serial No.
GTIN": 8888123400
1729700111
20884521012933
8888123400
1831000130
1904600085
8888133500
2012100128
20884521013060
8888119360P
2007800129
10884521157699
2034400078
1720000102
20884521157696
1904200103
1923400228
1932300203

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 9 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Covidien Llc

See all →

Moderate
EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
Moderate
Covidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
Moderate
Covidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Shiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Moderate
Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10

Same hazard · device leak