Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Medtronic Palindrome Chronic Catheter Kit - 14.5 Fr/Ch (4.8 mm) x 23 cm [Manufacturer’s Product #: 8888145015; GTIN / UPN / Material #: 10884521013162, 20884521013169, 10884521013162, 10884521013162, 20884521013169, 10884521013162; Lot #: 2221700131, 2224200233, 2230400271, 2230400272] [HKMD No.: 200223]
According to the MHRA, the manufacturer is initiating a recall of four (4) specific lots of Palindrome 14.5 Fr/Ch (4.8 mm) x 23 cm Chronic Catheter Kits. Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body. As of 8 Aug 2023, there were six (6) reported complaints: five (5) complaints from China and one (1) from the United States. No serious injuries or deaths have been reported.
For further information, please visit https://mhra-gov.filecamp.com/s/d/xB5LtuLo44sSd1a6
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 Aug 2023