Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models
FDA device recall Z-1914-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.
- Action taken
- Medtronic sent an Urgent Medical Device Recall letter, dated June 2015 to customers beginning June 12, 2015. The letter identified affected product, described the issue, requested that unused inventory be quarantined and returned to Medtronic. Customers should contact Customer Service at 800-854-3570 and reference RADAR #241958 to initiate a return and credit of product. Additionally a Customer Confirmation Certificate should be completed and faxed to 651-367-0612.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 1304 devices
- Distribution
- Worldwide Distribution - US Distribution including the states of : AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, and WI., and to the countries of : Belgium, Brazil, Canada, Colombia,
- Date initiated
- 2015-06-12
- Date posted
- 2015-06-26
- Date terminated
- 2016-03-09
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT (K875353) | Dlp, Inc. | 1988-03-22 |