Recall Z-1284-2024 ยท QJP Catheter, Percutaneous, Neurovasculature
Medos International Sarl
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
| Date | Mar 13, 2024 (initiated Feb 2, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 1343 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192804 | CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath Medos International SARL, Feb 27, 2020 |