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Open, Classified

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

FDA Recall Z-2481-2025 · Posted 2025-09-03

Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2025-08-06
Product Quantity41200 units

Reason for Recall

The catheters may not retain their shape.

Firm Action

Medtronic Cardiac Surgery issued an Urgent Medical Device Recall notice to its consignees on 08/06/2025 via UPS 2nd day delivery. The notice explained the issue with the device, potential harms if used, and requested the following: Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " " " Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this . " Please maintain a copy of this communication in your records. Although the issue has been corrected for newly manufactured lots, please be aware that Medtronic will have limited product availability for these items over the next few months. If the product is unavailable, you may work with your sales representative to explore potential replacement options that Medtronic can offer. Alternatively, Medtronic will issue a credit note if a suitable replacement is not available. For questions, please contact your Medtronic Field Representative.

Root Cause

Process change control

Distribution Pattern

Worldwide - US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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