FDA Medical Device Recalls (openFDA)
St Jude Medical: St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
- Recall number
- Z-0177-2015
- Recalling firm
- St Jude Medical
- Product
- St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
- Status
- Terminated
- Initiated
- 2014-10-14
- Posted
- 2014-11-06
- Terminated
- 2014-12-10
- Reason
- St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
- Root cause
- Labeling mix-ups
- Action
- St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.
- Quantity
- 26
- Distribution
- US Distribution including the states of CA, GA, NJ, NY, OR and PA.
- Lot, serial or model codes
- Batch # 4671318
- 510(k) numbers
- ["K894500"]
- PMA numbers
- not on file
- Product code
- DRF
- Firm FEI
- 3007562768
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28