Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): C315-HIS Delivery Catheter

Is my product affected?

C315-HIS Delivery Catheter

• UPC 00763000160180

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling 591 unused C315HIS Delivery Catheters across three lots due to reports that leads cannot be passed through the catheter. The affected catheters were distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.

The recalled lots are: C315HIS02 (Lot Number 0010567341), C315HIS03 (Lot Number 10568899), and C315HIS04 (Lot Number 10568900). The source does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

Details from the source

Reason for recall: Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. Distribution: Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan. Quantity: 591 units Lot/code info: GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls