FDA Medical Device Recalls (openFDA)
St. Jude Medical: US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
- Recall number
- Z-0174-2014
- Recalling firm
- St. Jude Medical
- Product
- US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy.
- Status
- Terminated
- Initiated
- 2013-10-11
- Posted
- 2013-11-06
- Terminated
- 2016-03-10
- Reason
- St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).
- Root cause
- Error in labeling
- Action
- The firm, St. Jude Medical (SJM), sent a "Urgent Medical Device Notice" dated 11 October 2013 to its consignees. The letter described the problem, the product involved in the recall and the actions to be taken. The consignees were instructed to discard the IFU received with the batches and replace it with the IFU received in conjunction with the notification letter. SJM has determined that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU. If you have any questions, contact Vice President, Quality, at 651-756-5402.
- Quantity
- 59
- Distribution
- US distribution: KS, MA, UT,TX, KY, OH.
- Lot, serial or model codes
- Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242.
- 510(k) numbers
- not on file
- PMA numbers
- ["P110016S003"]
- Product code
- OAD
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- 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