TactiSys Quartz Pack — Class II medical device recall Z-1284-2015
Terminated recall by St Jude Medical, reported 2015-03-25, distributed nationwide. A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
| Recall number | Z-1284-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical, Saint Paul, MN, United States |
| Recall initiated | 2014-11-25 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-05-06 |
| Distributed | Nationwide (US) |
| Quantity | 89 |
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 use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.
Reason for recall
A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1284-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.