Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endo
FDA device recall Z-0187-2014 · posted 2013-11-08 · Terminated
Recall details
- Recalling firm
- St. Jude Medical
- Reason for recall
- St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabled. These units have a cable connector configuration that is different than intended.
- Action taken
- Consignees were sent a St. Jude Medical "Urgent Medical Device Notice" dated 11 October 2013. The letter was addressed to Cath lab manger / Risk Manger. The letter described the problem and the product involved in the recall. The letter stated that it is acceptable to continue using these devices as long as the product is used in accordance with the IFU.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- OAD
- Quantity affected
- 46
- Distribution
- Nationwide Distribution including the states of KY, OH, TX, MA, and NC.
- Date initiated
- 2013-10-11
- Date posted
- 2013-11-08
- Date terminated
- 2014-06-09
- Location
- Plymouth, MN
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