Z-1284-2024Class I

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular...

Name: Z-1284-2024 CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular...
Creator: Medos International Sarl
Published: 2024-02-02
License: https://open.fda.gov/license/

Medos International SARL / initiated 2024-02-02 / Open, Classified

FDA source

Medos International Sarl began a recall of CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use on 2024-02-02. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1284-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-02-02
Posted: 2024-03-13
Recalling firm: Medos International SARL
Product: CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Product code: QJP Catheter, Percutaneous, Neurovasculature
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.
FDA 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 [email protected] 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"
Quantity in commerce: 1343 units
Distribution: Worldwide distribution.
Product codes and lots: a) GS9080SD: UPDATED 4/4/2024 UDI-DI 10886704082316, Lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719, 31154809, 31160736, 31174927, 31178955, 31189206, 31194710, 31194733, 31208988, 31212653, 31212661; b) GS9090SD: UPDATED 4/4/2024 UDI-DI 10886704082293, Lot numbers: 31094249, 31103843, 31108260, 31116484, 31116485, 31121039, 31121040, 31121043, 31121044, 31133637, 31133638, 31140740, 31140952, 31146720, 31150968, 31150969, 31154810, 31154811, 31160737, 31160738, 31168610, 31168611, 31174928, 31174930, 31178956, 31178957, 31178958, 31189207, 31189208, 31194711, 31194712, 31194734, 31194735, 31204436, 31208989, 31208990, 31208991, 31212654, 31212655, 31212663, 31225738; c) GS9095SD: UDI-DI 10886704082323, Lot Numbers: 31208992, 31212656

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1284-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1284-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-13

Product code QJP

K192804Class IICEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cmMedos International SARL / cleared 2020-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)