—#189295

Product

C315-HIS Delivery Catheter

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K101885
Affected 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)

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Written notification letter titled, "MEDICAL DEVICE RECALL C315HIS DELIVERY CATHETER" was sent to all consignees on 09/09/2021 via 2-day UPS delivery. The letter instructs the consignee to take the following actions: "Check your inventory for the catheters identified in Table 1 above. If the product has been consumed, please complete the enclosed Customer Confirmation Form and email to xxxxx@medtronic.com. No further actions are required. " If there is unused identified product in your inventory, quarantine and return it to Medtronic. Contact Medtronic Customer Service at xxxxxxx to initiate a product return. Your local Medtronic Representative can assist you in the return of this product. o Note: Root cause is under investigation for this issue. Return of the identified product will aid the investigation. Please complete the enclosed Customer Confirmation Form and email to xxxxxx@medtronic.com." The letter also instructs the consignee to share the notice with all those who need to be made aware with their organization or to any organization where the potentially affected products have been transferred.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.

Timeline

Recall initiated: 2021-09-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189295. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.