TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias t
FDA device recall Z-1284-2015 · posted 2015-03-17 · Terminated
Recall details
- Recalling firm
- St Jude Medical
- Reason for recall
- A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
- Action taken
- St. Jude Medical sent a Service Bulletin to inform of a TactiSys Configuration File update that needs to be performed. A technical service personnel will visit each consignee and performed the software change on-site. For questions about this Service Bulletin, contact Technical Support (ETechsupport@sjm.com).
- Root cause
- Software design
- Status
- Terminated
- Product code
- OAE
- Quantity affected
- 89
- Distribution
- US Nationwide Distribution in the states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL IN, KS, LA, MD, MA, MI, MN,MS, NE, NV,NH, NM, NY, NC, OH, OK OR, PA, TN, TX, UT, VA,WA.
- Date initiated
- 2014-11-25
- Date posted
- 2015-03-17
- Date terminated
- 2015-05-06
- Location
- Saint Paul, MN
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