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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 88688

Description: C315-HIS Delivery Catheter

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 88688 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0173-2022
Event ID88688
Event DescriptionC315-HIS Delivery Catheter
Product TypeDevices
DistributionDistributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
Quantity591 units
Recall ReasonMedtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Device Classification20211103
Device Code InfoGTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)
Center Classification Date20211022
Recall Initiation Date20210909
Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initial Notification Letter
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