The Recall Desk
SevereFDA (Devices)·Z-1315-2022·Announced 2022-07-13

Palindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect

Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I designation requires minimum severity score of 4. Although no illnesses or deaths have been reported, the defect in a critical dialysis catheter where unintended fluid return could cause serious patient harm justifies this classification.

Plain-English summary

Covidien has recalled the Palindrome Precision HSI Chronic Catheter, a sterile single-use medical device prescribed for acute and chronic hemodialysis, apheresis, and infusion. The recall affects 25,765 units with worldwide distribution across all U.S. states and territories and numerous countries internationally.

The catheters are being recalled because of a potential leaking condition in the hub component. Specifically, an inter-lumen void (an internal gap) in the hub may cause unintended fluid to return during use, potentially compromising the safety of the dialysis treatment.

Patients currently using these catheters should contact their healthcare provider or dialysis facility immediately to determine if their device is affected. Healthcare providers and facilities should verify product serial numbers against the recall list and discontinue use of recalled units. For information on replacement options and additional assistance, contact Covidien or the U.S. Food and Drug Administration.

The recalled product

Product
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Manufacturer
Covidien Llc
Hazard
  • fluid-leak
  • device-defect

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": 8888119369P
  • 2031800118
  • 10884521157736
  • 8888119369P
  • 1914400127
  • 20884521157733
  • 1914400128
  • 1933700096
  • 1934400105
  • 2001400076
  • 2005600026
  • 2012100180
  • 2012100187
  • 2017500127
  • 2021000082
  • 2026000164
  • 2028200156
  • 2028200165

Distribution

Distributed nationwide across the United States.