DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
FDA device recall Z-2482-2025 · posted 2025-09-03 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- The catheters may not retain their shape.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DWF
- Quantity affected
- 25261 units
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2025-08-06
- Date posted
- 2025-09-03
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFANT VENT CATHETER 12001 W/SIDE VENT (K834039) | Dlp, Inc. | 1984-01-03 |