St Jude Medical Recalls TactiSys Quartz Pack for Configuration Update
St Jude Medical is recalling 89 TactiSys Quartz Packs because a configuration update is needed to ensure the device appropriately recognizes all TactiCath catheters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a software configuration update to ensure proper device recognition. There are no reported injuries, illnesses, or fatalities, and the hazard is procedural rather than a direct physical defect causing harm.
Plain-English summary
St Jude Medical is recalling 89 units of the TactiSys Quartz Pack (PN-004 400). This medical device is used for percutaneous catheter radiofrequency ablation of atrial cardiac arrhythmias and allows for the visualization of contact force between the TactiCath quartz catheter tip and the heart wall.
The recall is being conducted because a configuration update is required on the TactiSys system to appropriately recognize all TactiCath catheters. The affected units were distributed nationwide in the United States, specifically 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, and WA.
Healthcare facilities and users should contact St Jude Medical for instructions on how to perform the necessary configuration update. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for…
- Manufacturer
- St Jude Medical
- Affected units
- 89
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 30078
- 30118
- 30368
- 30059
- 30098
- 30169
- 30110
- 30042
- 30108
- 30066
- 30067
- 30117
- 30172
- 30063
- 30061
- 30060
- 30161
- 30183
- 30129
- 30097
Distribution
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