CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single

FDA device recall Z-1284-2024 · posted 2024-03-13 · Open, Classified

Recall details

Recalling firm: Medos International Sarl
Reason for recall: Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
Action taken: Johnson&Johnson MedTech/DePuy Synthes issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 02/02/2024 via letter delivered by FedEx. The notice explained the issue and the risk and requested the affected inventory be quarantined and the notice be disseminated to all appropriate personnel. Further instructions state: "Complete the Business Reply Form (BRF) confirming receipt of this notice and scan and email signed form to OneMD-Field-Actions@its.jnj.com or fax it to (305) 265-6889, Attention Line: Cerebase FA2350411. Please return the BRF even if you do not have product subject to this recall. Follow instructions in the letter and immediately call 1-844-483-3882 to return any inventory of CEREBASE DA Guide Sheath devices subject to this recall. To receive credit reimbursement, customers must return product subject to this recall. Attention Line: Cerebase FA2350411"
Root cause: Under Investigation by firm
Status: Open, Classified
Product code: QJP
Quantity affected: 1343 units
Distribution: Worldwide distribution.
Date initiated: 2024-02-02
Date posted: 2024-03-13
Location: Le Locle, Switzerland

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm (K192804)	Medos International SARL	2020-02-27